Event Date |
Update Type |
Comment |
06 Jan 2021 |
Phase Change - Preregistration
|
Preregistration for Renal failure in USA (PO) before January 2021 [160]
Updated 08 Jan 2021
|
06 Jan 2021 |
Regulatory Status
|
The US FDA accepts regulatory application for Renal failure for review [160]
Updated 08 Jan 2021
|
06 Jan 2021 |
Regulatory Status
|
The US FDA grants priority review to a regulatory application for Renal failure [160]
Updated 08 Jan 2021
|
06 Jan 2021 |
Regulatory Status
|
The US FDA sets Prescription Drug User Fee Action date for Renal failure during second quarter of 2021. [160]
Updated 08 Jan 2021
|
23 Dec 2020 |
Trial Update
|
Nagoya Graduate School of Medicine terminates a clinical trial for Cardiovascular disorders in Japan (UMIN000027422)
Updated 06 Jan 2021
|
30 Nov 2020 |
Phase Change - Registered
|
Registered for Chronic heart failure (In the elderly, In adults) in Japan (PO) [164]
Updated 22 Dec 2020
|
19 Nov 2020 |
Regulatory Status
|
AstraZeneca expects regulatory decision for Chronic heart failure (In the elderly, In adults) in Japan (PO) in Q4 2020 [30]
Updated 19 Nov 2020
|
19 Nov 2020 |
Regulatory Status
|
AstraZeneca expects regulatory decision for Chronic heart failure (In the elderly, In adults) in China (PO) in the first half of 2021 [30]
Updated 19 Nov 2020
|
13 Nov 2020 |
Regulatory Status
|
AstraZeneca announces intention to submit regulatory filings for Renal failure in the US, in Q4 2020 [30]
Updated 08 Jan 2021
|
13 Nov 2020 |
Scientific Update
|
Updated efficacy data from the phase III DECLARE-TIMI 58 trial in Type-2 diabetes mellitus presented at the American Heart Association Scientific Sessions (AHA-2020) [118] [117]
Updated 22 Dec 2020
|
13 Nov 2020 |
Scientific Update
|
Updated efficacy data from a phase III trial in Chronic heart failure presented at American Heart Association Scientific Sessions 2020 (AHA-2020) [182]
Updated 22 Dec 2020
|
05 Nov 2020 |
Phase Change - Marketed
|
Launched for Chronic heart failure (In the elderly, In adults) in Norway, Liechtenstein, Iceland, European Union (PO) [161]
Updated 01 Dec 2020
|
05 Nov 2020 |
Phase Change - Registered
|
Registered for Chronic heart failure (In adults, In the elderly) in Iceland, Norway, Liechtenstein (PO) [161]
Updated 01 Dec 2020
|
05 Nov 2020 |
Phase Change - Registered
|
Registered for Chronic heart failure (In the elderly, In adults) in European Union (PO) [161]
Updated 09 Nov 2020
|
04 Nov 2020 |
Phase Change - Marketed
|
Launched for Type 2 diabetes mellitus in Sweden, Belgium, Indonesia, Philippines, Argentina, Brazil, Hungary (PO) before November 2020
Updated 04 Nov 2020
|
22 Oct 2020 |
Trial Update
|
Astrazeneca plans a phase II MIRACLE trial for Heart failure (Combination therapy) in December 2020 (NCT04595370) (EudraCT2020-003126-23)
Updated 22 Dec 2020
|
19 Oct 2020 |
Regulatory Status
|
The Committee for Medicinal Products for Human Use recommends approval of dapagliflozin (Forxiga®) for Chronic heart failure in European Union [162]
Updated 20 Oct 2020
|
05 Oct 2020 |
Regulatory Status
|
Dapagliflozin receives Breakthrough Therapy status for Renal failure in USA [166]
Updated 06 Oct 2020
|
01 Oct 2020 |
Regulatory Status
|
the NMPA approved an update to the label for dapagliflozin to include the positive CV outcomes and renal data from the DECLARE-TIMI 58 phase III trial in adults with Type 2 diabetes mellitus in China [30]
Updated 19 Nov 2020
|
21 Sep 2020 |
Scientific Update
|
Updated efficacy data from the phase III DECLARE-TIMI 58 trial in Type-2 diabetes mellitus presented at the 56th Annual Meeting of the European Association for the Study of Diabetes (EASD-2020) [119]
Updated 04 Nov 2020
|
07 Sep 2020 |
Phase Change - III
|
AstraZeneca terminates a phase III trial for Type 2 diabetes mellitus (Adjunctive treatment) in Thailand, Vietnam and China (PO) owing to business decision (NCT03608358)
Updated 18 Sep 2020
|
30 Aug 2020 |
Scientific Update
|
Adverse event and efficacy data from a phase III DAPA-CKD trial in Renal failure released by AstraZeneca [188]
Updated 02 Sep 2020
|
29 Aug 2020 |
Scientific Update
|
Adverse events data from the phase III DAPA-HF trial in Chronic heart failure presented at the ESC Congress 2020 - Annual Congress of the European Society of Cardiology (ESC-Card-2020) [181]
Updated 03 Nov 2020
|
27 Aug 2020 |
Phase Change - III
|
Phase-III clinical trials in COVID-2019 infections in Brazil (PO) before August 2020 (NCT04350593)
Updated 26 Nov 2020
|
17 Jul 2020 |
Regulatory Status
|
AstraZeneca receives Special Protocol Assessment for phase III DAPA-MI trial in Heart failure [190]
Updated 20 Jul 2020
|
17 Jul 2020 |
Regulatory Status
|
Dapagliflozin receives Fast track status from the US FDA for Heart failure following acute myocardial infarction (MI) [190]
Updated 20 Jul 2020
|
16 Jul 2020 |
Trial Update
|
AstraZeneca, Uppsala Clinical Research Center and Minap plans a phase III DAPA-MI trial in Heart failure in United Kingdom in December 2020 (NCT04564742) (EudraCT2020-000664-31) [190]
Updated 22 Dec 2020
|
09 Jul 2020 |
Trial Update
|
AstraZeneca completes a phase III DETERMINE preserved trial in Heart failure in USA, Argentina, Brazil, Bulgaria, Canada, Denmark, Italy, Japan, South Korea, Slovakia, South Africa, Sweden (PO) (NCT03877224)
Updated 29 Sep 2020
|
07 Jul 2020 |
Financial Update
|
Credit Suisse financial data update
Updated 12 Jul 2020
|
06 Jul 2020 |
Phase Change - Marketed
|
Launched for Chronic heart failure (In the elderly, In adults) in India (PO) after July 2020 [165]
Updated 10 Jul 2020
|
05 Jul 2020 |
Phase Change - Registered
|
Registered for Chronic heart failure (In the elderly, In adults) in India (PO) [165]
Updated 10 Jul 2020
|
04 Jul 2020 |
Phase Change - Preregistration
|
Preregistration for Chronic heart failure (In adults, In the elderly) in India (PO) before July 2020 [165]
Updated 10 Jul 2020
|
03 Jul 2020 |
Phase Change - II/III
|
Phase-II/III clinical trials in COVID-2019 infections (Combination therapy) in United Kingdom (PO) (NCT04393246)
Updated 09 Sep 2020
|
16 Jun 2020 |
Scientific Update
|
Efficacy data from a phase III DAPA-HF trial in Heart failure presented at the 80thAmerican Diabetes Association (ADA-2020) [180]
Updated 18 Jun 2020
|
12 Jun 2020 |
Trial Update
|
AstraZeneca completes the phase III DAPA-CKD trial in Renal failure in US, Canada, Denmark, South Korea, Poland, Russia, Spain, Sweden, Germany, Hungary, Ukraine, Brazil, Argentina, Vietnam, Peru, Philippines, China, India, Japan Mexico, and the UK (PO) (NCT03036150)
Updated 02 Sep 2020
|
12 Jun 2020 |
Scientific Update
|
Pharmacodynamics data from a phase II trial in Prediabetic state presented at the 80th Annual Scientific Sessions of the American Diabetes Association (ADA-2020) [201]
Updated 21 Aug 2020
|
12 Jun 2020 |
Scientific Update
|
Updated efficacy data from the phase III DECLARE-TIMI 58 trial in Type-2 diabetes mellitus presented at the 80th Annual Scientific Sessions of the American Diabetes Association (ADA-2020) [120]
Updated 21 Aug 2020
|
06 May 2020 |
Phase Change - Registered
|
Registered for Chronic heart failure (In the elderly, In adults) in USA (PO) [158]
Updated 08 May 2020
|
23 Apr 2020 |
Phase Change - III
|
Phase-III clinical trials in COVID-2019 infections in Europe (PO) [10]
Updated 27 Apr 2020
|
15 Apr 2020 |
Phase Change - III
|
Phase-III clinical trials in COVID-2019 infections in USA (PO) (NCT04350593) [10]
Updated 27 Apr 2020
|
06 Apr 2020 |
Trial Update
|
AstraZeneca completes a Phase-III clinical trials in Type-2 diabetes mellitus (In adolescents, In children, In adults) in Hungary, Israel, Mexico, Romania, Russia, United Kingdom, USA, (PO) (NCT02725593)
Updated 28 Apr 2020
|
31 Mar 2020 |
Trial Update
|
University Medical Center Hamburg-Eppendorf and AstraZeneca terminates a phase III trial for Type-2 diabetes mellitus (Combination therapy) in Germany due to delay in patient enrolment (PO, Tablet) (NCT03419624)
Updated 09 Apr 2020
|
30 Mar 2020 |
Trial Update
|
AstraZeneca terminates phase III DAPA-CKD trial in Renal failure in US, Canada, Denmark, South Korea, Poland, Russia, Spain, Sweden, Germany, Hungary, Ukraine, Brazil, Argentina, Vietnam, Peru, Philippines, China, India, Japan Mexico, and the UK (PO) due to early benefits [184] (NCT03036150)
Updated 02 Apr 2020
|
28 Mar 2020 |
Scientific Update
|
Efficacy data from the phase III DECLARE-TIMI 58 trial in Type-2 diabetes mellitus presented at the American College of Cardiology and World Congress of Cardiology (ACC-2020) [122] [121]
Updated 29 May 2020
|
11 Mar 2020 |
Phase Change - III
|
AstraZeneca temporarily suspends recruitment on a phase III trial for Type 2 diabetes mellitus (Adjunctive treatment) in Vietnam, Thailand (PO) to streamline current resources and re-evaluate study overall timeline (NCT03608358)
Updated 17 Mar 2020
|
10 Mar 2020 |
Phase Change - III
|
Phase-III clinical trials in Type 2 diabetes mellitus (Adjunctive treatment) in Vietnam (PO) before March 2020(NCT03608358)
Updated 17 Mar 2020
|
07 Mar 2020 |
Trial Update
|
AstraZeneca completes the phase III DETERMINE-reduced trial for Heart failure (In adults, In the elderly) in US, Canada, South Korea, Brazil, Denmark, Japan, Slovakia, South Africa and Sweden (PO) (NCT03877237) (EudraCT2018-003442-16)
Updated 03 Apr 2020
|
01 Mar 2020 |
Phase Change - Clinical
|
Clinical trials in Heart failure (Prevention, In the elderly) in Australia (PO) (ACTRN12619001393145)
Updated 11 Mar 2020
|
29 Jan 2020 |
Active Status Review
|
Dapagliflozin is still in phase III trials for Type 2 diabetes mellitus (Adjunctive treatment, In adolescents, In children) in USA, Australia, Argentina, United Kingdom, Ukraine, Turkey, Thailand, Taiwan, Russia, Romania, Philippines, New Zealand, Mexico, Malaysia, South Korea, Italy, Israel, India, Colombia, Chile, Brazil, Canada, Finland, Poland (PO) (NCT03199053)
Updated 29 Jan 2020
|
06 Jan 2020 |
Regulatory Status
|
FDA assigns PDUFA action date in second quarter of 2020 for dapagliflozin for Chronic heart failure [159]
Updated 08 May 2020
|
06 Jan 2020 |
Phase Change - Preregistration
|
Preregistration for Chronic heart failure (In the elderly, In adults) in USA (PO) before January 2020 [159]
Updated 08 Jan 2020
|
06 Jan 2020 |
Regulatory Status
|
Dapagliflozin receives priority review status for Chronic heart failure in USA [159]
Updated 08 Jan 2020
|
06 Jan 2020 |
Regulatory Status
|
US FDA accepts sNDA for dapagliflozin for Chronic heart failure for review [159]
Updated 08 Jan 2020
|
31 Dec 2019 |
Phase Change - Preregistration
|
Preregistration for Chronic heart failure (In the elderly, In adults) in China (PO) before December 2019 [163]
Updated 24 Feb 2020
|
31 Dec 2019 |
Phase Change - Preregistration
|
Preregistration for Chronic heart failure (In the elderly, In adults) in European Union (PO) before December 2019 [163]
Updated 24 Feb 2020
|
31 Dec 2019 |
Phase Change - Preregistration
|
Preregistration for Chronic heart failure (In the elderly, In adults) in Japan (PO) before December 2019 [163]
Updated 24 Feb 2020
|
31 Dec 2019 |
Regulatory Status
|
European Medicines Agency accepts a regulatory filing for Dapagliflozin for Chronic heart failure for review [163]
Updated 24 Feb 2020
|
04 Dec 2019 |
Regulatory Status
|
AstraZeneca expects regulatory decision for Type II diabetes and established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors from cardiovascular outcomes trial in China in the first half of 2020 [185]
Updated 04 Dec 2019
|
18 Nov 2019 |
Scientific Update
|
Efficacy and safety data from a phase III DAPA-HF trial in Chronic heart failure released by AstraZeneca [176]
Updated 28 Nov 2019
|
24 Oct 2019 |
Trial Update
|
AstraZeneca complete enrolment in a phase-III clinical trials in Renal failure in the US, Canada, Denmark, South Korea, Poland, Russia, Spain, Sweden, Germany, Hungary, Ukraine, Brazil, Argentina, Vietnam, Peru, Philippines, China, India, Japan Mexico, and the UK (NCT03036150) [185]
Updated 04 Dec 2019
|
21 Oct 2019 |
Phase Change - Registered
|
Registered for Cardiovascular disorders (to reduce the risk of hospitalisation for heart failure in adults with type 2 diabetes mellitus and established cardiovascular disease or multiple cardiovascular risk factors) in USA (PO) [112]
Updated 24 Oct 2019
|
19 Oct 2019 |
Phase Change - Marketed
|
Launched for Cardiovascular disorders in USA (PO)
Updated 01 Apr 2020
|
16 Oct 2019 |
Trial Update
|
AstraZeneca plans a phase II the LEAVE-DM trial for Heart failure (Prevention) in Australia (ACTRN12619001393145)
Updated 16 Oct 2019
|
16 Sep 2019 |
Scientific Update
|
Efficacy and adverse events data from the phase III DECLARE TIMI 58 trial in Type-2 diabetes mellitus presented at the 55th Annual Meeting of the European Association for the Study of Diabetes (EASD-2019) [126]
Updated 10 Jan 2020
|
16 Sep 2019 |
Scientific Update
|
Efficacy and adverse events data from the phase III DEPICT 2 trial in Type 1 diabetes mellitus presented at the data was presented at the 55th Annual Meeting of the European Association for the Study of Diabetes (EASD-2019) [149]
Updated 09 Jan 2020
|
16 Sep 2019 |
Scientific Update
|
Efficacy data from a the DIVERSITY-CVR trial in Type 2 diabetes mellitus presented at the 55th Annual Meeting of the European Association for the Study of Diabetes (EASD-2019) [194]
Updated 09 Jan 2020
|
16 Sep 2019 |
Regulatory Status
|
Dapagliflozin receives Fast Track designation for Chronic heart failure (PO) in USA [167]
Updated 18 Sep 2019
|
01 Sep 2019 |
Scientific Update
|
Efficacy and adverse events data from the phase III DAPA-HF trial in Chronic heart failure presented at the the ESC Congress 2019: Annual Congress of the European Society of Cardiology (ESC-Card-2019) [178]
Updated 04 Sep 2019
|
31 Aug 2019 |
Scientific Update
|
Efficacy data from a phase III DECLARE-TIMI 58 trial in Type 2 diabetes mellitus presented at the ESC Congress 2019: Annual Congress of the European Society of Cardiology (ESC-Card-2019 ) [127]
Updated 02 Jan 2020
|
27 Aug 2019 |
Regulatory Status
|
Dapagliflozin receives Fast Track designation for Renal failure (PO) in USA [168]
Updated 28 Aug 2019
|
21 Aug 2019 |
Scientific Update
|
The phase III DAPA-HF trial for Chronic heart failure met its primary endpoint, reported by AstraZeneca [179]
Updated 22 Aug 2019
|
05 Aug 2019 |
Regulatory Status
|
EMA approves update to dapagliflozin label to include positive cardiovascular (CV) outcomes and renal data from the Phase III DECLARE-TIMI 58 trial in adults with type-2 diabetes [29]
Updated 12 Aug 2019
|
17 Jul 2019 |
Trial Update
|
AstraZeneca completes a phase III trial in Chronic Heart Failure in Argentina, Brazil, Denmark, USA, United Kingdom, Canada, China, Bulgaria, Czechia (Czech Republic), India, Japan, Netherlands, Poland, Russia, Slovakia, Sweden, Taiwan, Germany, Hungary and Vietnam (NCT03036124)
Updated 22 Aug 2019
|
16 Jul 2019 |
Regulatory Status
|
AstraZeneca receives complete response letter from the US FDA for dapagliflozin in Type 1 diabetes mellitus (Adjunctive therapy)
Updated 16 Jul 2019
|
12 Jul 2019 |
Regulatory Status
|
NICE recommends use of Dapagliflozin as an treatment option for Type 1 diabetes mellitus (in combination with insulin) in the UK [36]
Updated 16 Jul 2019
|
27 Jun 2019 |
Regulatory Status
|
The CHMP of EMA adopts a positive opinion, recommending modification of existing authorisation in Type 2 diabetes mellitus (both as monotherapy and combination therapy) [26]
Updated 02 Jul 2019
|
11 Jun 2019 |
Scientific Update
|
Efficacy data from the phase II PRE-D trial in Obesity, and Prediabetic state presented at the 79th Annual Scientific Sessions of the American Diabetes Association (ADA-2019) [198]
Updated 15 Jul 2019
|
09 Jun 2019 |
Scientific Update
|
Efficacy data from sub-analysis of renal data from the phase III DECLARE-TIMI 58 trial in Type-2 diabetes released by Astra Zeneca [124] [123] [177]
Updated 13 Jun 2019
|
07 Jun 2019 |
Scientific Update
|
Efficacy data from the phase III DEPICT-1 and DEPICT-2 trials in Type 1 diabetes mellitus (involving patients in whom dapagliflozin was discontinued for safety reasons) presented at the 79th Annual Scientific Sessions of the American Diabetes Association (ADA-2019) [147]
Updated 16 Jul 2019
|
07 Jun 2019 |
Scientific Update
|
Efficacy data from the phase III DECLARE-TIMI 58 trial in Type-2 diabetes presented at the 79th Annual Scientific Sessions of the American Diabetes Association (ADA-2019) [128]
Updated 16 Jul 2019
|
07 Jun 2019 |
Scientific Update
|
Pooled efficacy and adverse events data from DEPICT 1 and 2 trials in Type 1 diabetes mellitus presented at the 79th Annual Scientific Sessions of the American Diabetes Association (ADA-2019) [148]
Updated 16 Jul 2019
|
26 Apr 2019 |
Regulatory Status
|
AstraZeneca announces intention to submit regulatory filings for Renal failure in the EU, Japan and China in Q4 2020 [30]
Updated 08 Jan 2021
|
26 Apr 2019 |
Regulatory Status
|
AstraZeneca announces intention to submit regulatory filings for Chronic heart failure in the US, the EU, Japan and China in or after 2020 (AstraZeneca pipeline, April 2019)
Updated 24 Feb 2020
|
26 Apr 2019 |
Regulatory Status
|
AstraZeneca announces intention to submit regulatory applications for Type-2 diabetes mellitus in China in first half of 2019 (AstraZeneca pipeline, April 2019)
Updated 03 May 2019
|
09 Apr 2019 |
Phase Change - III
|
Phase-III clinical trials in Chronic heart failure (In adults, In the elderly) in Sweden, South Africa, Slovakia (PO) (NCT03877237)
Updated 03 Apr 2020
|
09 Apr 2019 |
Trial Update
|
AstraZeneca initiates the phase III DETERMINE-reduced trial for Heart failure (In adults, In the elderly) in Brazil, Denmark and Japan (PO) after April 2019 (NCT03877237) (EudraCT2018-003442-16)
Updated 03 Apr 2020
|
09 Apr 2019 |
Trial Update
|
AstraZeneca initiates the phase III DETERMINE-reduced trial for Heart failure (In adults, In the elderly) in USA and Canada (PO) (NCT03877237)
Updated 30 Apr 2019
|
09 Apr 2019 |
Phase Change - III
|
Phase-III clinical trials in Chronic heart failure (In adults, In the elderly) in South Korea (PO) (NCT03877237)
Updated 29 Apr 2019
|
08 Apr 2019 |
Trial Update
|
AstraZeneca and Ono Pharmaceutical terminate a clinical trial for Type 2 diabetes mellitus (coupled with exercise) in Japan (PO) (UMIN000020263)
Updated 15 Apr 2019
|
04 Apr 2019 |
Phase Change - III
|
Phase-III clinical trials in Heart failure in Italy, Italy, Bulgaria, South Africa, Slovakia (PO) (NCT03877224)
Updated 29 Sep 2020
|
04 Apr 2019 |
Trial Update
|
AstraZeneca initiates the phase III DETERMINE-preserved trial for Heart failure in Argentina, Brazil, Denmark, Japan, South Africa and Sweden (PO) (NCT03877224)
Updated 29 Sep 2020
|
04 Apr 2019 |
Trial Update
|
AstraZeneca initiates the phase III DETERMINE-preserved trial for Heart failure in USA, South Korea and Canada (PO) (NCT03877224)
Updated 30 Apr 2019
|
28 Mar 2019 |
Phase Change - Marketed
|
Launched for Type 1 diabetes mellitus (Adjunctive treatment) in Austria, Croatia, Czech Republic, Denmark, Netherlands, Finland, Poland, Portugal, Slovakia, Slovenia, Spain, United Kingdom (PO), before April 2019
Updated 18 Apr 2019
|
27 Mar 2019 |
Phase Change - Marketed
|
Launched for Type 1 diabetes mellitus (Adjunctive treatment) in Iceland, Norway (PO), prior to March 2019
Updated 18 Apr 2019
|
27 Mar 2019 |
Phase Change - Marketed
|
Launched for Type 1 diabetes mellitus (Adjunctive treatment) in Japan (PO) [144]
Updated 18 Apr 2019
|
27 Mar 2019 |
Phase Change - Registered
|
Registered for Type 1 diabetes mellitus (Adjunctive treatment) in Liechtenstein (PO), prior to March 2019
Updated 18 Apr 2019
|
27 Mar 2019 |
Phase Change - Registered
|
Registered for Type 2 diabetes mellitus (Combination therapy, Monotherapy) in Liechtenstein (PO), prior to March 2019
Updated 18 Apr 2019
|
27 Mar 2019 |
Phase Change - Registered
|
Registered for Type 1 diabetes mellitus (Adjunctive treatment) in Japan (PO) [144]
Updated 01 Apr 2019
|
27 Mar 2019 |
Phase Change - Registered
|
Registered for Type 1 diabetes mellitus (Adjunctive treatment) in European Union (PO) [140]
Updated 27 Mar 2019
|
15 Mar 2019 |
Trial Update
|
AstraZeneca plans the phase III DETERMINE trial for Heart failure in USA, Argentina, Bulgaria, Canada, Denmark, Italy, South Korea, Slovakia, South Africa and Sweden in April 2019 (PO) (NCT03877224)
Updated 30 Apr 2019
|
15 Mar 2019 |
Trial Update
|
AstraZeneca plans the phase III DETERMINE-reduced trial for Heart failure in USA, Brazil, Argentina, Canada, Denmark, South Korea, Slovakia, South Africa and Sweden in April 2019 (PO) (NCT03877237)
Updated 29 Apr 2019
|
04 Mar 2019 |
Trial Update
|
The Japan Society for Patient Reported Outcome (PRO) and Saitama Medical University completes a phase II trial for Type II diabetes mellitus in Japan (UMIN000029640;R000033859)
Updated 15 Mar 2019
|
04 Mar 2019 |
Trial Update
|
Toho University Omori Medical Center and the Japan Society for Patient Reported Outcome (PRO) in collaboration with AstraZeneca completes the phase III DIVERSITY-CVR trial in Type II diabetes mellitus in Japan (UMIN000028014)
Updated 15 Mar 2019
|
04 Mar 2019 |
Trial Update
|
AstraZeneca and Ono Pharmaceutical completes a clinical trial for Type 2 diabetes mellitus in Japan (UMIN000023834)
Updated 13 Mar 2019
|
27 Feb 2019 |
Phase Change - III
|
Phase-III clinical trials in Type 2 diabetes mellitus (Adjunctive treatment) in China (PO) after February 2019 (NCT03608358)
Updated 18 Sep 2020
|
27 Feb 2019 |
Phase Change - III
|
Phase-III clinical trials in Type 2 diabetes mellitus (Adjunctive treatment) in Thailand (PO) (NCT03608358)
Updated 29 Mar 2019
|
14 Feb 2019 |
Regulatory Status
|
AstraZeneca expects regulatory decision for Type I diabetes mellitus in the EU and Japan in the first half of 2019 [23]
Updated 20 Feb 2019
|
14 Feb 2019 |
Regulatory Status
|
AstraZeneca expects regulatory decision for Type I diabetes mellitus in the US in the second half of 2019 [23]
Updated 20 Feb 2019
|
01 Feb 2019 |
Phase Change - Preregistration
|
Preregistration for Type 1 diabetes mellitus (Adjunctive treatment) in USA (PO) prior to February 2019 [142]
Updated 05 Feb 2019
|
01 Feb 2019 |
Regulatory Status
|
The Committee for Medicinal Products for Human Use of the EMA recommends approval of dapagliflozin for Type 1 diabetes mellitus (Adjunctive treatment) in European Union [142]
Updated 05 Feb 2019
|
31 Dec 2018 |
Phase Change - Marketed
|
Launched for Type 2 diabetes mellitus in China (PO) [23]
Updated 20 Feb 2019
|
22 Nov 2018 |
Trial Update
|
AstraZeneca KK and Ono Pharmaceutical completes the phase II DEFENCE trial in Type 2 diabetes mellitus in Japan(UMIN000018754)
Updated 06 Dec 2018
|
12 Nov 2018 |
Scientific Update
|
Efficacy and safety data from the phase III DECLARE-TIMI 58 trial in Type-2 diabetes released by Astra Zeneca [115]
Updated 18 Nov 2018
|
01 Nov 2018 |
Phase Change - Registered
|
Registered for Type 2 diabetes mellitus (Combination therapy) in China (PO) [23]
Updated 20 Feb 2019
|
31 Oct 2018 |
Phase Change - Preregistration
|
Preregistration for Type 2 diabetes mellitus (Combination therapy) in China (PO) [23]
Updated 20 Feb 2019
|
30 Oct 2018 |
Trial Update
|
AstraZeneca completes the phase II PRE-D trial in Prediabetic state and Obesity in Denmark (NCT02695810)
Updated 15 Jul 2019
|
01 Oct 2018 |
Scientific Update
|
Updated efficacy data from a phase IIIb trial in Type 2 diabetes mellitus presented at the 54th Annual Meeting of the European Association for the Study of Diabetes (EASD-2018) [60]
Updated 22 Oct 2018
|
01 Oct 2018 |
Scientific Update
|
Pooled efficacy data from the phase III DEPICT 1 and 2 trials in Type 1 diabetes mellitus presented at the 54th Annual Meeting of the European Association for the Study of Diabetes (EASD-2018) [205] [206]
Updated 18 Oct 2018
|
11 Sep 2018 |
Trial Update
|
AstraZeneca and Bristol-Myers Squibb completes the phase III DECLARE-TIMI58 trial for Type-2 diabetes mellitus (add-on therapy, patients at high risk of a cardiovascular event) in USA, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, China, Czech Republic, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Japan, South Korea, Mexico, Netherlands, Philippines, Poland, Romania, Russia, Slovakia, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, Ukraine, United Kingdom and Vietnam (PO) (NCT01730534)
Updated 11 Oct 2018
|
27 Aug 2018 |
Trial Update
|
AstraZeneca initiates the phase III DELIVER trial for Chronic heart failure in USA and Canada (PO) (NCT03619213)
Updated 19 Sep 2018
|
23 Aug 2018 |
Trial Update
|
AstraZeneca completes enrolment in the DAPA-HF phase III trial for Chronic heart failure [174]
Updated 28 Aug 2018
|
14 Aug 2018 |
Trial Update
|
AstraZeneca initiates the phase III DELIVER trial for Chronic heart failure in Hungary (EudraCT2018-000802-46)
Updated 31 Aug 2018
|
07 Aug 2018 |
Trial Update
|
AstraZeneca plans the phase III DELIVER trial for Heart failure in USA, Brazil, Canada, Czech Republic, Hungary, Japan, Mexico, Netherlands, Peru, Romania, Russian Federation, Saudi Arabia, Spain, Taiwan and Vietnam (NCT03619213) [174]
Updated 31 Aug 2018
|
31 Jul 2018 |
Trial Update
|
AstraZeneca plans the DS Navigation phase III trial for Type II diabetes mellitus in China and Vietnam , (NCT03608358)
Updated 28 Mar 2019
|
25 Jun 2018 |
Scientific Update
|
Efficacy and adverse events data from the phase III DEPICT-1 trial in Type 1 diabetes mellitus released by AstraZeneca [59]
Updated 29 Jun 2018
|
25 Jun 2018 |
Scientific Update
|
Efficacy and adverse events data from the phase III DEPICT-2 trial in Type 1 diabetes mellitus released by AstraZeneca [59]
Updated 29 Jun 2018
|
25 Jun 2018 |
Scientific Update
|
Efficacy data from a phase IIIb trial in Type 2 diabetes mellitus released by AstraZeneca [59]
Updated 29 Jun 2018
|
24 Jun 2018 |
Biomarker Update
|
Biomarkers information updated
Updated 31 Aug 2018
|
22 Jun 2018 |
Scientific Update
|
Adverse events, pharmacokinetics and pharmacodynamics data from a phase I trial in Type-1 diabetes mellitus presented at the 78th Annual Scientific Sessions of the American Diabetes Association (ADA-2018) [155]
Updated 12 Jul 2018
|
21 May 2018 |
Phase Change - Preregistration
|
Preregistration for Type-1 diabetes mellitus (Adjunctive treatment) in Japan (PO) [145]
Updated 21 May 2018
|
18 Apr 2018 |
Trial Update
|
AstraZeneca completes the phase III DEPICT 2 trial in Type-1 diabetes in USA, Poland, Belgium, Canada, Germany, Sweden, Russia, Switzerland, Netherlands, Japan, Chile, Argentina and United Kingdom (NCT02460978)
Updated 22 May 2018
|
04 Apr 2018 |
Trial Update
|
AstraZeneca completes a phase II/III trial in Type-2 diabetes mellitus (combination therapy with saxagliptin) in USA, Australia, Canada, Japan, South Korea, Mexico, South Africa, Spain and Taiwan (PO) (NCT02547935)
Updated 03 May 2018
|
19 Mar 2018 |
Scientific Update
|
Interim efficacy adverse events data from a phase III DERIVE trial in Type -2 diabetes mellitus released by AstraZeneca [53]
Updated 21 Mar 2018
|
17 Mar 2018 |
Scientific Update
|
Efficacy and adverse events data from the phase III DERIVE trial Type-2 diabetes mellitus presented at the The 100th Annual Meeting of the Endocrine Society (AMES-2018) [56]
Updated 24 Apr 2018
|
05 Mar 2018 |
Phase Change - Preregistration
|
Preregistration for Type-1 diabetes mellitus in European Union (PO) [143]
Updated 13 Mar 2018
|
19 Feb 2018 |
Trial Update
|
University Medical Center Hamburg-Eppendorf and AstraZeneca initiates enrolment in a phase III trial for Type-2 diabetes mellitus (Combination therapy) in Germany (PO, Tablet) (NCT03419624)
Updated 16 May 2018
|
02 Feb 2018 |
Regulatory Status
|
AstraZeneca announces intention to submit regulatory applications for Type-2 diabetes mellitus (add-on therapy, patients at high risk of a cardiovascular event) in European Union in 2019 [55]
Updated 23 Mar 2020
|
02 Feb 2018 |
Regulatory Status
|
AstraZeneca announces intention to submit regulatory applications for Type-2 diabetes mellitus (add-on therapy, patients at high risk of a cardiovascular event) in USA in 2019 [55]
Updated 24 Oct 2019
|
02 Feb 2018 |
Regulatory Status
|
AstraZeneca announces intention to submit regulatory applications for Type-1 diabetes mellitus in USA in the second half of 2018 [55]
Updated 05 Feb 2019
|
02 Feb 2018 |
Regulatory Status
|
AstraZeneca announces intention to submit regulatory applications for Type-1 diabetes mellitus in European Union in the first half of 2018 [55]
Updated 22 May 2018
|
02 Feb 2018 |
Scientific Update
|
Adverse events data from the phase III DEPICT 1 and DEPICT 2 trials in Type 1 diabetes mellitus released by AstraZeneca [55]
Updated 13 Feb 2018
|
02 Feb 2018 |
Scientific Update
|
Interim efficacy and adverse events data from the phase III DERIVE trial in Type-2 diabetes mellitus released by AstraZeneca [55]
Updated 13 Feb 2018
|
28 Dec 2017 |
Trial Update
|
AstraZeneca completes a phase III trial for Type-2 diabetes mellitus (Adjunctive treatment, Combination therapy) in USA, Hungary, Poland, Romania, Slovakia and South Africa (PO) (NCT02229396)
Updated 27 Feb 2018
|
19 Dec 2017 |
Trial Update
|
Kinderkrankenhaus auf der Bult and AstraZeneca completes a phase I trial in Type-1 diabetes mellitus (Adjunctive treatment) in Germany (PO) (NCT02987738)
Updated 12 Mar 2018
|
30 Nov 2017 |
Trial Update
|
Tokushima University Graduate School and AstraZeneca completed the phase-II DBOT trial in Type-2 diabetes mellitus (Adjunctive treatment) in Japan (PO) (UMIN000019457)
Updated 03 May 2019
|
12 Nov 2017 |
Phase Change - II
|
Phase-II clinical trials in Kidney disorders in Netherlands (PO) (NCT03190694)
Updated 17 May 2018
|
11 Nov 2017 |
Scientific Update
|
Pharmacodynamics data from a preclinical study in Diabetes mellitus presented at the 90th Annual Scientific Sessions of the American Heart Association [157]
Updated 28 Nov 2017
|
09 Nov 2017 |
Trial Update
|
Bristol-Myers Squibb and AstraZeneca completes a phase III trial for Type-2 diabetes mellitus (Combination therapy) in USA, Czech Republic, Denmark, Germany, Hungary, Mexico, Poland, Romania, South Africa, Spain and Sweden (PO) (NCT02551874)
Updated 08 Dec 2017
|
07 Nov 2017 |
Trial Update
|
AstraZeneca completes a phase III trial for Type -2 diabetes mellitus (In adults, In the elderly) in Bulgaria, Canada, Italy, USA, Czech Republic, Poland, Spain, Sweden (NCT02413398)
Updated 20 Dec 2017
|
04 Nov 2017 |
Phase Change - No development reported
|
No recent reports of development identified for phase-I development in Type-2-diabetes-mellitus(In adolescents, In children) in Mexico (PO, Tablet)
Updated 04 Nov 2017
|
01 Nov 2017 |
Trial Update
|
The Japan Society for Patient Reported Outcome (PRO) and Saitama Medical University initiates a phase II trial for Type II diabetes mellitus in Japan (UMIN000029640;R000033859)
Updated 15 Mar 2019
|
11 Oct 2017 |
Phase Change - III
|
Phase-III clinical trials in Type 2 diabetes mellitus (Adjunctive treatment, In adolescents, In children) in United Kingdom, Ukraine, Turkey, Thailand, Russia, Taiwan, Romania, Romania, Mexico, New Zealand, Philippines, Argentina, Australia, Brazil, Canada, Chile, Colombia, Colombia, India, Israel, Italy, South Korea, Malaysia (PO)
Updated 29 Jan 2020
|
11 Oct 2017 |
Trial Update
|
AstraZeneca withdraws phase III trial in Type 2 diabetes mellitus (Adjunctive treatment, In adolescents, In children) in China (NCT03199053)
Updated 29 Jan 2020
|
11 Oct 2017 |
Phase Change - III
|
Phase-III clinical trials in Type-2 diabetes mellitus (In adolescents, In children, Adjunctive treatment) in Finland, Poland, USA (PO) (EudraCT2015-005042-66) (NCT03199053)
Updated 27 Oct 2017
|
11 Sep 2017 |
Scientific Update
|
Safety and efficacy data from a phase III trial in Type-2 diabetes mellitus presented at the 53rd Annual Meeting of the European Association for the Study of Diabetes (EASD-2017) [51]
Updated 05 Oct 2017
|
01 Sep 2017 |
Trial Update
|
Nagoya Graduate School of Medicine initiates enrolment in a clinical trial for Cardiovascular disorders in Japan (UMIN000027422)
Updated 06 Jan 2021
|
25 Aug 2017 |
Trial Update
|
Bristol-Myers Squibb completes the phase III DEPICT 1 trial in Type-1 diabetes mellitus in USA, United Kingdom, Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Hungary, Italy, Israel, Mexico, Romania, Sweden and Spain (PO) (NCT02268214)
Updated 10 Oct 2017
|
10 Jul 2017 |
Trial Update
|
Toho University and AstraZeneca initiates enrolment in the DIVERSITY-CVR trial for Type II diabetes mellitus in Japan (PO) (UMIN000028014)
Updated 02 Nov 2017
|
03 Jul 2017 |
Trial Update
|
AstraZeneca plans a phase III trial for Type-2 diabetes mellitus (In children, In adolescents, Adjunctive treatment) (PO) (NCT03199053) (EudraCT2015-005042-66)
Updated 29 Jan 2020
|
21 Jun 2017 |
Trial Update
|
AstraZeneca completes a phase III trial in Type-2 diabetes mellitus (Adjunctive treatment, Combination therapy) in Russia, Germany, Canada, Czech Republic, Mexico, USA (NCT02681094)
Updated 27 Jul 2017
|
15 Jun 2017 |
Trial Update
|
AstraZeneca completes a phase III trial in Type-1 diabetes mellitus (Combination therapy) in Japan (PO) (NCT02582814)
Updated 19 Jul 2017
|
11 May 2017 |
Phase Change - Marketed
|
Launched for Type-2 diabetes mellitus (Combination therapy, Monotherapy) in Spain, Slovenia, Slovakia, Germany, Finland, Croatia (PO) before May 2017
Updated 11 May 2017
|
11 May 2017 |
Phase Change - Marketed
|
Launched for Type-2 diabetes mellitus in Thailand, Singapore, Hong Kong, Malaysia, Israel, Ireland, Cyprus (PO) before May 2017
Updated 11 May 2017
|
10 May 2017 |
Phase Change - Discontinued
|
Discontinued as no recent development recorded - Phase-I for Type-2 diabetes mellitus (In volunteers) in USA (PO, Liquid) before May 2017
Updated 10 May 2017
|
10 May 2017 |
Phase Change - No development reported(Preregistration)
|
No development reported - Preregistration for Type-2 diabetes mellitus in South Africa (PO) before May 2017
Updated 10 May 2017
|
27 Apr 2017 |
Phase Change - Registered
|
Registered for Type-2 diabetes mellitus in China (PO) before April 2017 (AstraZeneca pipeline, April 2017)
Updated 09 May 2017
|
22 Feb 2017 |
Phase Change - III
|
Phase-III clinical trials in Renal failure in Vietnam, Ukraine, Hungary and Germany (PO) after February 2017 (NCT03036150)
Updated 03 Jul 2017
|
22 Feb 2017 |
Phase Change - III
|
Phase-III DAPA-CKD clinical trials in Renal failure in Sweden, Spain, Russia, Poland, South Korea, Denmark, USA (PO)after February 2017 (NCT03036150)
Updated 11 May 2017
|
09 Feb 2017 |
Phase Change - I
|
Phase-I clinical trials in Type-1 diabetes mellitus (Adjunctive treatment) in Germany (PO) (NCT02987738)
Updated 05 Apr 2017
|
08 Feb 2017 |
Phase Change - III
|
Phase-III clinical trials in Chronic heart failure in India, China (PO) after February 2017 (NCT03036124)
Updated 28 Aug 2018
|
06 Feb 2017 |
Phase Change - III
|
Phase-III clinical trials in Type-2 diabetes mellitus (In adolescents, In children, In adults) in Russia before February 2017 (NCT02725593) (PO)
Updated 06 Feb 2017
|
02 Feb 2017 |
Phase Change - III
|
Phase-III clinical trials in Renal failure in United Kingdom, Mexico, Japan, India, China (PO) (EudraCT2016-003896-24) (NCT03036150)
Updated 29 Nov 2019
|
02 Feb 2017 |
Phase Change - III
|
Phase-III clinical trials in Renal failure in Peru after February 2017 (PO), Philippines after February 2017 (PO) (NCT03036150)
Updated 05 Oct 2017
|
02 Feb 2017 |
Phase Change - III
|
Phase-III clinical trials in Renal failure in Argentina, Brazil (PO) (NCT03036150)
Updated 27 Jul 2017
|
01 Feb 2017 |
Phase Change - III
|
Phase-III clinical trials in Chronic heart failure in Brazil, Argentina, United Kingdom after February 2017 (PO) (NCT03036124)
Updated 05 Oct 2017
|
01 Feb 2017 |
Phase Change - III
|
Phase-III clinical trials in Chronic heart failure in Vietnam, Hungary and Germany (PO) after February 2017(NCT03036124)
Updated 03 Jul 2017
|
01 Feb 2017 |
Phase Change - III
|
Phase-III DAPA-HF clinical trials in Chronic heart failure in Taiwan, Sweden, Slovakia, Russia, Poland, Netherlands, Japan, Czech Republic, Bulgaria (PO) after February 2017 (NCT03036124)
Updated 11 May 2017
|
01 Feb 2017 |
Phase Change - III
|
Phase-III clinical trials in Chronic heart failure in Canada, USA (PO) (NCT03036124)
Updated 28 Feb 2017
|
01 Feb 2017 |
Phase Change - III
|
Phase-III clinical trials in Renal failure in Canada (PO) (NCT03036150)
Updated 22 Feb 2017
|
26 Jan 2017 |
Trial Update
|
AstraZeneca plans a phase III trial for Renal failure in USA, Brazil, Argentina, Canada, Denmark, Germany, Hungary, South Korea, Peru, Philippines, Russia, Spain, Sweden, Ukraine and Vietnam (NCT03036150)
Updated 07 Feb 2017
|
19 Jan 2017 |
Phase Change - III
|
Phase-III clinical trials in Chronic heart failure (In the elderly, In adults) in Denmark (PO) (Eudra2016-003897-41 )
Updated 06 Feb 2017
|
23 Nov 2016 |
Regulatory Status
|
NICE recommends use of Dapagliflozin as triple therapy for Type 2 diabetes mellitus (in combination with metformin and a sulfonylurea) in the UK [31]
Updated 05 Dec 2016
|
15 Nov 2016 |
Scientific Update
|
Safety and efficacy data from the phase II EFFECT II clinical trial in Type-2 diabetes mellitus reported at the 67th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD-2016) [135]
Updated 02 Mar 2017
|
12 Sep 2016 |
Phase Change - III
|
Phase-III clinical trials in Chronic heart failure in United Kingdom (unspecified route) [172]
Updated 14 Sep 2016
|
12 Sep 2016 |
Phase Change - III
|
Phase-III clinical trials in Renal failure in United Kingdom [172]
Updated 14 Sep 2016
|
01 Sep 2016 |
Trial Update
|
AstraZeneca and Ono Pharmaceutical initiates enrolment in a clinical trial for Type 2 diabetes mellitus in Japan (UMIN000023834)
Updated 13 Mar 2019
|
10 Aug 2016 |
Phase Change - Marketed
|
Launched for Type-2 diabetes mellitus in Chile (PO) before August 2016
Updated 10 May 2017
|
05 Jul 2016 |
Trial Update
|
AstraZeneca plans a phase III trial for Type-2 diabetes mellitus (Combination therapy, In children, In adolescents) in United Kingdom (UKCRN31254)
Updated 14 Jul 2016
|
30 Jun 2016 |
Trial Update
|
AstraZeneca initiates enrolment in a phase III trial for Type-2 Diabetes mellitus (In children, In adolescents, In adults) in USA (PO) (NCT02725593)
Updated 14 Jul 2016
|
22 Jun 2016 |
Phase Change - III
|
Phase-III clinical trials in Type 2 diabetes mellitus (In adolescents, In adults, In children) in Romania (PO) (NCT02725593)
Updated 28 Apr 2020
|
16 Jun 2016 |
Trial Update
|
AstraZeneca and Ono Pharmaceutical initiate enrolment in a clinical trial for Type 2 diabetes mellitus (coupled with exercise) in Japan (PO) (UMIN000020263)
Updated 15 Apr 2019
|
11 Jun 2016 |
Scientific Update
|
Efficacy and adverse event data from two pooled analysis in Type 2 diabetes released by AstraZeneca [207]
Updated 27 Jun 2016
|
07 Jun 2016 |
Trial Update
|
AstraZeneca completes a phase I trial for Type-1 diabetes mellitus (Combination therapy) in Japan (PO) (NCT02582840)
Updated 16 Jun 2016
|
01 Jun 2016 |
Phase Change - III
|
Phase-III clinical trials in Type-2 diabetes mellitus (In adolescents, In children, In adults) in Hungary, Israel, Mexico, United Kingdom (PO) (NCT02725593)
Updated 05 Dec 2016
|
01 Jun 2016 |
Phase Change - III
|
Phase-III clinical trials in Type-2 diabetes mellitus (In children, In adolescents, In adults) in USA (PO) (NCT02725593)
Updated 27 Jul 2016
|
24 May 2016 |
Regulatory Status
|
NICE recommends use of Dapagliflozin as monotherapy for Type 2 diabetes mellitus (in adults for whom metformin is contraindicated) in the UK [32]
Updated 27 May 2016
|
19 May 2016 |
Trial Update
|
AstraZeneca withdraws prior to enrolment a phase IV trial for Type-2 diabetes mellitus (in combination with metformin) in Russia (NCT02719132)
Updated 10 May 2017
|
31 Mar 2016 |
Trial Update
|
Tokushima University Graduate School and AstraZeneca initiate the phase-II DBOT clinical trial in Type-2 diabetes mellitus (Adjunctive treatment) in Japan (PO) (UMIN000019457)
Updated 10 May 2017
|
29 Mar 2016 |
Trial Update
|
AstraZeneca plans a phase III trial for Type-2 Diabetes mellitus (In children, In adolescents, In adults) in Hungary, Israel, Mexico, Romania, Russia, United Kingdom and USA (PO) (NCT02725593)
Updated 06 Apr 2016
|
25 Mar 2016 |
Trial Update
|
AstraZeneca plans a phase IV trial for Type-2 diabetes mellitus (in combination with metformin) in Russia (NCT02719132)
Updated 30 Mar 2016
|
23 Mar 2016 |
Licensing Status
|
AstraZeneca and Sun Pharma agree to promote, market and distribute dapagliflozin for Type-2 diabetes mellitus in India [1]
Updated 12 Apr 2016
|
23 Mar 2016 |
Phase Change - Marketed
|
Launched for Type-2 diabetes mellitus (Monotherapy, In adults) in India (PO) [1] (DCGI website, April 2016)
Updated 12 Apr 2016
|
01 Mar 2016 |
Trial Update
|
AstraZeneca completes a phase II trial in Obesity (Combination therapy) in Sweden (NCT02313220)
Updated 30 Nov 2016
|
01 Mar 2016 |
Trial Update
|
AstraZeneca initiates a phase-II clinical trial in Type-2 diabetes mellitus (Adjunctive treatment) in Japan (PO) (UMIN000018754)
Updated 17 Nov 2016
|
26 Feb 2016 |
Regulatory Status
|
The EMA’s Committee for Medicinal Products for Human Use confirms the recommendations made by PRAC to minimise the risk of diabetic ketoacidosis in patients taking SGLT2 inhibitors [24]
Updated 16 Mar 2016
|
25 Feb 2016 |
Phase Change - Marketed
|
Launched for Type-2 diabetes mellitus (Adjunctive therapy, In adults) in India (PO) [1] (DCGI website, April 2016)
Updated 12 Apr 2016
|
23 Feb 2016 |
Phase Change - Marketed
|
Launched for Type-2 diabetes mellitus in Ukraine (PO) before February 2016
Updated 10 May 2017
|
22 Feb 2016 |
Phase Change - Registered
|
Registered for Type-2 diabetes mellitus in Ukraine (PO) before February 2016
Updated 10 May 2017
|
12 Feb 2016 |
Regulatory Status
|
The EMA’s Pharmacovigilance Risk Assessment Committee recommends discontinuing treatment with dapagliflozin if diabetic ketoacidosis is suspected [25]
Updated 17 Feb 2016
|
01 Feb 2016 |
Phase Change - II
|
Phase-II clinical trials in Obesity in Denmark (PO) (NCT02695810)
Updated 15 Jul 2019
|
01 Feb 2016 |
Phase Change - II
|
Phase-II clinical trials in Prediabetic state in Denmark (PO) (NCT02695810)
Updated 15 Jul 2019
|
01 Feb 2016 |
Phase Change - III
|
Phase-III clinical trials in Type-2 diabetes mellitus (Adjunctive treatment, Combination therapy) in Russia, Germany, Canada (PO) after february 2016 (NCT02681094)
Updated 10 May 2017
|
01 Feb 2016 |
Trial Update
|
AstraZeneca initiates a phase III trial for Type-2 diabetes mellitus (Combination therapy, Adjunctive treatment) in Czech Republic, Mexico (PO) after February 2016(NCT02681094)
Updated 10 May 2017
|
01 Feb 2016 |
Trial Update
|
AstraZeneca initiates a phase III trial for Type-2 diabetes mellitus (Combination therapy, Adjunctive treatment) in USA (NCT02681094)
Updated 15 Mar 2016
|
01 Jan 2016 |
Trial Update
|
Bristol-Myers Squibb completes a phase III trial in Type-2 diabetes mellitus (Combination therapy) in South Korea, Singapore and China (PO) (NCT02096705)
Updated 25 Feb 2016
|
01 Jan 2016 |
Trial Update
|
AstraZeneca plans a phase III trial for Type-2 diabetes mellitus (Combination therapy, Adjunctive treatment) in USA, Canada, Germany, Czech Republic, Mexico and Russia (PO) (NCT02681094)
Updated 17 Feb 2016
|
31 Dec 2015 |
Trial Update
|
AstraZeneca completes the EFFECT II trial in Type-2 diabetes mellitus with non-alcoholic fatty liver disease in Sweden (NCT02279407)
Updated 03 Feb 2016
|
03 Dec 2015 |
Phase Change - Marketed
|
Launched for Type-2 diabetes mellitus in Switzerland (PO) before December 2015
Updated 10 May 2017
|
26 Oct 2015 |
Trial Update
|
AstraZeneca plans phase I trial (Part A) for Type-1 diabetes mellitus (Combination therapy) in Japan (PO) (NCT02582840)
Updated 26 Oct 2015
|
20 Oct 2015 |
Trial Update
|
Bristol-Myers Squibb and AstraZeneca initiates enrolment in a phase III trial for Type-2 diabetes mellitus (Combination therapy) in Germany (PO) (NCT02551874)
Updated 08 Dec 2017
|
17 Oct 2015 |
Trial Update
|
Bristol-Myers Squibb completes a phase III trial investigating the efficacy and effects of dapagliflozin on endothelial and microvascular function of the retinal circulation in patients with type 2 diabetes mellitus in Germany (EudraCT2013-004169-14)
Updated 02 Nov 2015
|
16 Oct 2015 |
Trial Update
|
AstraZeneca and Ono Pharmaceutical conduct a phase II DIET trial in Type-2 diabetes mellitus in Japan(UMIN000019192)
Updated 05 Nov 2015
|
07 Oct 2015 |
Phase Change - Marketed
|
Launched for Type-2 diabetes mellitus in Kuwait (PO) before October 2015
Updated 22 Jun 2016
|
01 Oct 2015 |
Phase Change - III
|
Phase-III clinical trials in Type-2 diabetes mellitus (Adjunctive treatment, Combination therapy) in Sweden, Spain, South Africa, Romania, Poland, Mexico, Hungary, Denmark, Czech Republic (PO) after October 2015 (NCT02551874)
Updated 10 May 2017
|
01 Oct 2015 |
Phase Change - II
|
Phase-II clinical trials in Type-2 diabetes mellitus (Adjunctive treatment) in Japan (PO) (UMIN000018754)
Updated 24 May 2016
|
01 Oct 2015 |
Phase Change - I
|
Phase-I clinical trials in Type-1 diabetes mellitus (Combination therapy) in Japan (PO) (NCT02582840)
Updated 10 Nov 2015
|
01 Oct 2015 |
Phase Change - III
|
Phase-III clinical trials in Type-1 diabetes mellitus (Combination therapy) in Japan (PO) (NCT02582814)
Updated 10 Nov 2015
|
01 Oct 2015 |
Phase Change - III
|
Phase-III clinical trials in Type-2 diabetes mellitus (Combination therapy; Adjunctive treatment) in USA (PO) (NCT02551874)
Updated 10 Nov 2015
|
23 Sep 2015 |
Trial Update
|
Bristol-Myers Squibb and AstraZeneca plan a phase III trial for Type-2 diabetes mellitus (Combination therapy) in Czech Republic, Denmark, Germany, Hungary, Mexico, Poland, Romania, Russia, South Africa, Spain , Sweden and USA (NCT02551874)
Updated 23 Sep 2015
|
01 Sep 2015 |
Trial Update
|
AstraZeneca initiates a phase II/III trial in Type-2 diabetes mellitus (combination therapy with saxagliptin) in Australia, Canada, Japan, South Korea, Mexico, South Africa, Spain and Taiwan after September 2015 (NCT02547935)
Updated 10 May 2017
|
01 Sep 2015 |
Trial Update
|
AstraZeneca initiates a phase II/III trial in Type-2 diabetes mellitus (combination therapy with saxagliptin) in USA (NCT02547935)
Updated 05 Nov 2015
|
31 Aug 2015 |
Trial Update
|
AstraZeneca plans a phase II/III trial for Type-2 diabetes mellitus (Combination therapy with saxagliptin) in US, Australia, Canada, Spain and Taiwan (NCT02547935)
Updated 21 Sep 2015
|
28 Aug 2015 |
Trial Update
|
AstraZeneca initiates enrolment in a phase III trial for Type -2 diabetes mellitus (In adults, In the elderly) in Sweden, Czech Republic and Poland after August 2015 (EudraCT2015-000804-24)
Updated 09 May 2017
|
28 Aug 2015 |
Trial Update
|
AstraZeneca initiates enrolment in a phase III trial for Type-2 diabetes mellitus (In adults, In the elderly) in Spain (EudraCT2015-000804-24)
Updated 17 Sep 2015
|
08 Jul 2015 |
Phase Change - III
|
Phase-III clinical trials in Type-1 diabetes mellitus in Russia, Switzerland, Netherlands, Japan, Chile, Argentina (PO) after July 2015 (NCT02460978)
Updated 13 Feb 2018
|
08 Jul 2015 |
Trial Update
|
AstraZeneca initiates enrolment in the phase III DEPICT 2 trial in Type-1 diabetes in Belgium, Canada, Germany, Sweden, and United Kingdom after July 2015 (NCT02460978)
Updated 13 Feb 2018
|
01 Jul 2015 |
Phase Change - III
|
Phase-III clinical trials in Type-1 diabetes mellitus in Poland (PO) (NCT024609780
Updated 07 Aug 2015
|
30 Jun 2015 |
Active Status Review
|
Dapagliflozin is still in Preregistration for Type-2 diabetes mellitus in China
Updated 05 Oct 2015
|
15 Jun 2015 |
Trial Update
|
AstraZeneca initiates enrolment in a phase III trial for Type -2 diabetes mellitus (In adults, In the elderly) in Bulgaria, Canada, Italy, USA (NCT02413398)
Updated 20 Dec 2017
|
06 Jun 2015 |
Scientific Update
|
Efficacy and adverse events data from a phase III trial in Type 2 diabetes mellitus (Combination therapy with saxagliptin and metformin) presented at the 75th Annual Scientific Sessions of the American Diabetes Association (ADA-2015) [103]
Updated 09 Jul 2015
|
01 Jun 2015 |
Trial Update
|
AstraZeneca and Bristol-Myers Squibb initiates enrolment in the phase III Depict 2 trial for Type 1 diabetes mellitus in USA (NCT02460978)
Updated 07 Aug 2015
|
27 Apr 2015 |
Phase Change - Marketed
|
Launched for Type-2 diabetes mellitus in Greece (PO)
Updated 05 Nov 2015
|
18 Mar 2015 |
Active Status Review
|
Phase III development for Type-2 diabetes mellitus (combination therapy) is ongoing in Israel, India, Singapore, Philippines, Puerto Rico and Taiwan
Updated 18 Mar 2015
|
18 Mar 2015 |
Phase Change - No development reported(III)
|
No recent reports of development identified - Phase-III for Type-2 diabetes mellitus (Monotherapy) in Taiwan (PO)
Updated 18 Mar 2015
|
18 Mar 2015 |
Phase Change - No development reported(III)
|
No recent reports of development identified - Phase-III for Type-2 diabetes mellitus (Combination therapy) in Peru (PO)
Updated 18 Mar 2015
|
04 Mar 2015 |
Phase Change - III
|
Phase-III clinical trials in Type-2 diabetes mellitus (Combination therapy) in Hong Kong (PO)
Updated 18 Mar 2015
|
25 Feb 2015 |
Phase Change - Registered
|
Registered for Type 2 diabetes mellitus (Adjunctive treatment, In adults) in India (PO) [37]
Updated 10 Jul 2020
|
25 Feb 2015 |
Phase Change - Registered
|
Registered for Type 2 diabetes mellitus (Monotherapy, In adults) in India (PO) [37]
Updated 10 Jul 2020
|
24 Feb 2015 |
Phase Change - Preregistration
|
Preregistration for Type 2 diabetes mellitus (Adjunctive treatment) in India (PO) before February 2015 [37]
Updated 10 Jul 2020
|
24 Feb 2015 |
Phase Change - Preregistration
|
Preregistration for Type 2 diabetes mellitus (Monotherapy, In adults) in India (PO) [37]
Updated 10 Jul 2020
|
07 Feb 2015 |
Phase Change - Marketed
|
Launched for Type-2 diabetes mellitus in United Arab Emirates (PO) before February 2015
Updated 22 Jun 2016
|
01 Feb 2015 |
Trial Update
|
AstraZeneca and Bristol-Myers Squibb complete enrolment in a phase III trial for Type 2 diabetes mellitus (triple combination therapy) in USA, Puerto Rico, Romania, Russia, Poland, Mexico, Czech Republic and United Kingdom (NCT01646320)
Updated 18 Mar 2015
|
01 Jan 2015 |
Trial Update
|
AstraZeneca initiates enrolment in the EFFECT II trial for Type-2 diabetes mellitus with non-alcoholic fatty liver disease in Sweden (NCT02279407)
Updated 15 Feb 2015
|
18 Dec 2014 |
Phase Change - Marketed
|
Launched for Type-2 diabetes mellitus in Canada (PO) after December 2014
Updated 11 May 2017
|
17 Dec 2014 |
Phase Change - Registered
|
Registered for Type-2 diabetes mellitus in Canada (PO)
Updated 25 Dec 2014
|
01 Dec 2014 |
Phase Change - II
|
Phase-II clinical trials in Obesity (Combination therapy) in Sweden (PO) (NCT02313220)
Updated 30 Nov 2016
|
01 Nov 2014 |
Phase Change - III
|
Phase-III DEPICT-1 clinical trials in Type-1 diabetes mellitus in Romania, Mexico, Canada (PO) after November 2014 (NCT02268214)
Updated 11 May 2017
|
01 Nov 2014 |
Phase Change - III
|
Phase-III clinical trials in Type-1 diabetes mellitus in Australia, France, Israel and Spain (PO) (NCT02268214) after November 2014
Updated 15 Jul 2015
|
01 Nov 2014 |
Phase Change - III
|
Phase-III clinical trials in Type-1 diabetes mellitus in Hungary, Belgium, Sweden, United Kingdom, Austria, Germany and Italy (PO) after November 2014(NCT02268214, EudraCT2013-004674-97)
Updated 18 Mar 2015
|
01 Nov 2014 |
Phase Change - III
|
Phase-III clinical trials in Type-1 diabetes mellitus in Denmark, Finland and USA (PO)
Updated 02 Dec 2014
|
29 Oct 2014 |
Trial Update
|
AstraZeneca plans the EFFECT II trial for Type-2 diabetes mellitus with non-alcoholic fatty liver disease in Sweden (NCT02279407)
Updated 04 Nov 2014
|
15 Oct 2014 |
Trial Update
|
Bristol-Myers Squibb and AstraZeneca plan a phase III trial for Type-1 diabetes mellitus in USA and European Union (NCT02268214)
Updated 13 Nov 2014
|
01 Sep 2014 |
Trial Update
|
AstraZeneca initiates enrolment in a phase III trial for Type-2 diabetes mellitus (Adjunctive treatment, Combination therapy) in USA, Hungary, Poland, Romania, Slovakia and South Africa (NCT02229396) after September 2014
Updated 15 Jul 2015
|
01 Sep 2014 |
Trial Update
|
Bristol-Myers Squibb and AstraZeneca completes a phase I trial in Type-2 diabetes mellitus (In adolescents, In children) in USA and Mexico (NCT01525238)
Updated 02 Dec 2014
|
01 Sep 2014 |
Phase Change - Marketed
|
Launched for Type-2 diabetes mellitus in South Korea before September 2014 (PO)
Updated 30 Oct 2014
|
01 Sep 2014 |
Trial Update
|
AstraZeneca initiates enrolment in a phase III trial for Type-2 diabetes mellitus in USA (NCT02229396)
Updated 09 Oct 2014
|
19 Aug 2014 |
Phase Change - Registered
|
Registered for Type-2 diabetes mellitus in Switzerland (PO) [45]
Updated 10 May 2017
|
17 Jul 2014 |
Phase Change - Marketed
|
Launched for Type-2 diabetes mellitus in New Zealand (PO) prior to July 2014
Updated 18 Mar 2015
|
01 Jul 2014 |
Trial Update
|
AstraZeneca plans a postmarketing safety trial for Type-2 diabetes mellitus (In the elderly) in Japan (NCT02200627)
Updated 02 Sep 2014
|
23 May 2014 |
Phase Change - Marketed
|
Launched for Type-2 diabetes mellitus in Japan (PO)
Updated 27 May 2014
|
19 May 2014 |
Phase Change - Marketed
|
Launched for Type-2 diabetes mellitus in USA (PO)
Updated 19 May 2014
|
13 May 2014 |
Scientific Update
|
Efficacy and adverse events data from a phase III trial in Type-2 diabetes mellitus released by AstraZeneca [208]
Updated 15 May 2014
|
31 Mar 2014 |
Phase Change - III
|
Phase-III clinical trials in Type-2 diabetes mellitus (Combination therapy) in China (PO) (NCT02096705)
Updated 28 Aug 2014
|
24 Mar 2014 |
Phase Change - Registered
|
Registered for Type-2 diabetes mellitus in Japan (PO)
Updated 25 Mar 2014
|
01 Mar 2014 |
Phase Change - III
|
Phase-III clinical trials in Type-2 diabetes mellitus (Combination therapy) in South Korea, Singapore after March 2014 (PO) (NCT02096705)
Updated 25 Feb 2016
|
01 Feb 2014 |
Licensing Status
|
AstraZeneca acquires dapagliflozin from Bristol-Myers Squibb [3]
Updated 10 Feb 2014
|
31 Jan 2014 |
Phase Change - Marketed
|
Launched for Type-2 diabetes mellitus in Russia (PO)
Updated 10 May 2017
|
31 Jan 2014 |
Trial Update
|
Bristol-Myers Squibb and AstraZeneca complete a phase III trial in Type-2 diabetes mellitus in the USA, Canada, Mexico, Poland, Puerto Rico, Romania, South Africa and South Korea (NCT01606007)
Updated 15 May 2014
|
08 Jan 2014 |
Phase Change - Registered
|
Registered for Type-2 diabetes mellitus in USA (PO)
Updated 10 Jan 2014
|
01 Jan 2014 |
Phase Change - Registered
|
Registered for Type-2 diabetes mellitus in Russia (PO) before January 2014
Updated 10 May 2017
|
13 Dec 2013 |
Phase Change - Registered
|
Registered for Type-2 diabetes mellitus in Chile (PO) before December 2013
Updated 10 May 2017
|
12 Dec 2013 |
Regulatory Status
|
The FDA Endocrinologic and Metabolic Drugs Advisory Committee recommends approval of dapagliflozin for Type-2 diabetes mellitus in USA [13]
Updated 19 Dec 2013
|
03 Dec 2013 |
Licensing Status
|
AstraZeneca KK & Ono Pharmaceutical agree to co-promote dapagliflozin in Japan for Type-2 diabetes mellitus [7]
Updated 04 Dec 2013
|
22 Nov 2013 |
Phase Change - Registered
|
Registered for Type-2 diabetes mellitus in Argentina (PO)
Updated 25 Nov 2013
|
24 Sep 2013 |
Phase Change - Registered
|
Registered for Type-2 diabetes mellitus in Brazil before September 2013 (PO)
Updated 02 Oct 2013
|
24 Sep 2013 |
Scientific Update
|
Final efficacy and adverse events data from a phase III trial in Type-2 diabetes mellitus presented at the 49th Annual Meeting of the European Association for the Study of Diabetes (EASD-2013) [46]
Updated 02 Oct 2013
|
31 Aug 2013 |
Trial Update
|
AstraZeneca and Bristol-Myers Squibb complete their phase III trial in Type-2 diabetes mellitus in Canada, Czech Republic, Germany, Poland, Slovakia, and Spain (NCT01392677)
Updated 02 Oct 2013
|
01 Aug 2013 |
Phase Change - Marketed
|
Launched for Type-2 diabetes mellitus (monotherapy and combination therapy) in Australia (PO)
Updated 25 Sep 2013
|
25 Jul 2013 |
Regulatory Status
|
AstraZeneca and Bristol-Myers Squibb resubmit the NDA for dapagliflozin in Type-2 diabetes mellitus to the US FDA [14]
Updated 26 Jul 2013
|
25 Jul 2013 |
Regulatory Status
|
The US FDA sets PDUFA date of 11 January 2014 for NDA review for Type-2 diabetes mellitus [14]
Updated 26 Jul 2013
|
25 Jun 2013 |
Phase Change - Marketed
|
Launched for Type-2 diabetes mellitus in Mexico (PO) after June 2013
Updated 11 May 2017
|
24 Jun 2013 |
Phase Change - Registered
|
Registered for Type-2 diabetes mellitus in Mexico (PO)
Updated 04 Jul 2013
|
24 Jun 2013 |
Phase Change - Registered
|
Registered for Type-2 diabetes mellitus in New Zealand (PO)
Updated 04 Jul 2013
|
24 Jun 2013 |
Scientific Update
|
Efficacy and adverse events data from a phase IIa trial in Type-1 diabetes mellitus presented at the 73rd Annual Scientific Sessions of the American Diabetes Association (ADA-2013) [152]
Updated 04 Jul 2013
|
12 Jun 2013 |
Phase Change - No development reported(Preregistration)
|
No development reported - Preregistration for Type-2 diabetes mellitus in Canada (PO)
Updated 12 Jun 2013
|
29 May 2013 |
Regulatory Status
|
The National Institute for Health and Care Excellence publishes positive final appraisal determination for dapagliflozin in Type-2 diabetes mellitus [33]
Updated 06 Jun 2013
|
29 May 2013 |
Regulatory Status
|
The National Institute for Health and Care Excellence publishes final draft guidance recommending the use of dapagliflozin in combination with metformin or insulin for Type-2 diabetes mellitus [34]
Updated 05 Jun 2013
|
30 Apr 2013 |
Trial Update
|
AstraZeneca & Bristol-Myers Squibb initiate enrolment in the phase III DECLARE-TIMI58 trial for Type-2 diabetes mellitus (add-on therapy, patients at high risk of a cardiovascular event) in Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, China, Czech Republic, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Japan, South Korea, Mexico, Netherlands, Philippines, Poland, Romania, Russia, Slovakia, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, Ukraine, United Kingdom and Vietnam after April 2013(NCT01730534)
Updated 10 May 2017
|
30 Apr 2013 |
Trial Update
|
AstraZeneca & Bristol-Myers Squibb initiate enrolment in the phase III DECLARE-TIMI58 trial for Type-2 diabetes mellitus (add-on therapy, patients at high risk of a cardiovascular event) in USA (NCT01730534)
Updated 05 Jun 2013
|
31 Mar 2013 |
Trial Update
|
Bristol-Myers Squibb completes a phase III trial in Type-2 diabetes mellitus in India, China and South Korea (NCT01095666)
Updated 05 Jul 2013
|
31 Mar 2013 |
Phase Change - Preregistration
|
Preregistration for Type-2 diabetes mellitus in Japan (PO)
Updated 27 Apr 2013
|
14 Feb 2013 |
Phase Change - Marketed
|
Launched for Type-2 diabetes mellitus (Combination therapy) in Denmark (PO)
Updated 06 Jun 2013
|
14 Feb 2013 |
Phase Change - Marketed
|
Launched for Type-2 diabetes mellitus (Monotherapy in metformin-intolerant patients) in Denmark (PO)
Updated 06 Jun 2013
|
01 Feb 2013 |
Trial Update
|
Bristol-Myers Squibb completes a phase I drug interaction trial of saxagliptin and dapagliflozin in healthy volunteers in USA (NCT01662999)
Updated 01 Mar 2013
|
01 Feb 2013 |
Regulatory Status
|
The NICE in the UK issues draft guidance that does not recommend reimbursement of dapagliflozin in combination with antihyperglycaemics, including insulin, for patients with Type-2 diabetes mellitus [35]
Updated 07 Feb 2013
|
31 Jan 2013 |
Phase Change - Preregistration
|
Preregistration for Type-2 diabetes mellitus in China (PO)
Updated 27 Apr 2013
|
01 Jan 2013 |
Trial Update
|
AstraZeneca and Bristol-Myers Squibb completes a phase III trial for Type-2 diabetes mellitus in Argentina, France, Germany, Italy, Mexico, the Netherlands, South Africa, Spain, Sweden and the United Kingdom (NCT00660907)
Updated 20 Nov 2014
|
01 Dec 2012 |
Trial Update
|
AstraZeneca and Bristol-Myers Squibb completes a phase III trial for Type-2 diabetes mellitus in USA, Argentina, Australia, Austria, Bulgaria, Canada, Chile, Germany, Hungary and Poland (NCT01042977)
Updated 20 Nov 2014
|
01 Dec 2012 |
Trial Update
|
AstraZeneca and Bristol-Myers Squibb completes a phase III trial for Type-2 diabetes mellitus in USA, Argentina, Canada, Germany, Romania, Slovakia, Spain, Taiwan and Vietnam (NCT01031680)
Updated 20 Nov 2014
|
30 Nov 2012 |
Phase Change - Marketed
|
Launched for Type-2 diabetes mellitus (Combination therapy) in Netherlands, Czech Republic, Austria, Poland and Portugal (PO) after November 2012
Updated 18 Mar 2015
|
30 Nov 2012 |
Phase Change - Marketed
|
Launched for Type-2 diabetes mellitus (Monotherapy) in Netherlands, Czech Republic, Austria, Poland and Portugal (PO) after November 2012
Updated 18 Mar 2015
|
15 Nov 2012 |
Phase Change - Marketed
|
Launched for Type-2 diabetes mellitus (Combination therapy, Monotherapy) in Norway (PO) after November 2012
Updated 11 May 2017
|
15 Nov 2012 |
Trial Update
|
AstraZeneca plans a multinational phase 3 trial (DECLARE-TIMI58) for Type 2 diabets mellitus (in patients with high risk for cardiovascular disorders) (NCT01730534)
Updated 16 Jan 2013
|
14 Nov 2012 |
Phase Change - Registered
|
Registered for Type-2 diabetes mellitus (monotherapy and combination therapy) in Iceland and Norway (PO)
Updated 25 Nov 2013
|
14 Nov 2012 |
Phase Change - Marketed
|
Launched for Type-2 diabetes mellitus (Combination therapy) in United Kingdom (PO) - First global launch
Updated 06 Jun 2013
|
14 Nov 2012 |
Phase Change - Marketed
|
Launched for Type-2 diabetes mellitus (Monotherapy in metformin-intolerant patients) in United Kingdom (PO) - First global launch
Updated 06 Jun 2013
|
14 Nov 2012 |
Phase Change - Registered
|
Registered for Type-2 diabetes mellitus in European Union (Combination therapy) (PO) - First global approval
Updated 16 Nov 2012
|
14 Nov 2012 |
Phase Change - Registered
|
Registered for Type-2 diabetes mellitus in European Union (Monotherapy in metformin-intolerant patients) (PO) - First global approval
Updated 16 Nov 2012
|
31 Oct 2012 |
Trial Update
|
Bristol-Myers Squibb and AstraZeneca completes a phase II trial in Type-1 diabetes mellitus in US (NCT01498185)
Updated 13 May 2013
|
22 Oct 2012 |
Trial Update
|
Bristol-Myers Squibb initiates enrolment in a phase I drug interaction trial of saxagliptin and dapagliflozin in healthy volunteers in USA (NCT01662999)
Updated 01 Mar 2013
|
05 Oct 2012 |
Phase Change - Registered
|
Registered for Type-2 diabetes mellitus (Combination therapy) in Australia (PO)
Updated 07 Mar 2013
|
05 Oct 2012 |
Phase Change - Registered
|
Registered for Type-2 diabetes mellitus (Monotherapy in metformin-intolerant patients) in Australia (PO)
Updated 07 Mar 2013
|
30 Sep 2012 |
Trial Update
|
AstraZeneca and Bristol-Myers Squibb initiate enrolment in a phase III trial for Type 2 diabetes mellitus (triple combination therapy) in Puerto Rico, Romania, Russia, Poland, Mexico, Czech Republic and United Kingdom (NCT01646320)
Updated 18 Mar 2015
|
30 Sep 2012 |
Trial Update
|
AstraZeneca and Bristol-Myers Squibb initiate enrolment in a phase III trial for Type 2 diabetes mellitus (triple combination therapy) in USA (NCT01646320)
Updated 28 Dec 2012
|
21 Sep 2012 |
Regulatory Status
|
The EMA approves Paediatric Investigation Plan for Type-2 diabetes mellitus
Updated 12 Nov 2012
|
28 Aug 2012 |
Trial Update
|
Bristol-Myers Squibb plans a phase I drug interaction trial of saxagliptin and dapagliflozin in healthy volunteers in USA (NCT01662999)
Updated 28 Aug 2012
|
31 Jul 2012 |
Trial Update
|
Bristol-Myers Squibb and AstraZenec plan a phase III trial for Type-2 diabetes mellitus in USA, Canada and Mexico (NCT01646320)
Updated 31 Jul 2012
|
12 Jul 2012 |
Trial Update
|
Bristol-Myers Squibb initiates enrolment in a phase III trial (dapagliflozin combination therapy with metformin and saxagliptin) for Type-2 diabetes mellitus in Canada (NCT01606007)
Updated 11 Feb 2014
|
12 Jul 2012 |
Trial Update
|
AstraZeneca and Bristol-Myers Squibb initiate enrolment in a phase III trial for Type 2 diabetes mellitus (triple combination therapy) in USA (NCT01606007)
Updated 12 Nov 2012
|
11 Jul 2012 |
Trial Update
|
AstraZeneca and Bristol-Myers Squibb complete enrolment in their phase III trial in Type-2 diabetes mellitus in Canada, Czech Republic, Germany, Poland, Slovakia, and Spain (NCT01392677)
Updated 25 Jul 2012
|
30 Jun 2012 |
Phase Change - Preregistration
|
Preregistration for Type-2 diabetes mellitus in emerging markets (PO)
Updated 04 Oct 2012
|
09 Jun 2012 |
Trial Update
|
AstraZeneca and Bristol-Myers Squibb plan a phase III trial (combination therapy) for Type 2 diabetes mellitus in the USA, Canada, Germany and Mexico (NCT01606007)
Updated 13 Jun 2012
|
30 May 2012 |
Phase Change - I
|
Phase-I clinical trials in Type-2 diabetes mellitus (In adolescents, In children) in Mexico (PO) after May 2012
Updated 02 Dec 2014
|
30 May 2012 |
Phase Change - I
|
Phase-I clinical trials in Type-2 diabetes mellitus (in children and adolescents) in USA (PO)
Updated 30 Jan 2013
|
23 May 2012 |
Scientific Update
|
Safety and efficacy data from a phase III trial in Type-2 diabetes mellitus (addition to sitagliptin with/without metformin) presented at the 72nd Annual Scientific Sessions of the American Diabetes Association (ADA-2012) [209]
Updated 13 Jun 2012
|
20 Apr 2012 |
Regulatory Status
|
CHMP recommends approval of dapagliflozin for Type-2 diabetes mellitus in EU [28]
Updated 23 Apr 2012
|
09 Mar 2012 |
Trial Update
|
AstraZeneca and Bristol-Myers Squibb complete a phase III trial in Type-2 diabetes mellitus (monotherapy) in Japan (NCT01294423)
Updated 10 Apr 2012
|
15 Feb 2012 |
Phase Change - II
|
Phase II clinical trials in Type-1 diabetes mellitus in USA (PO)
Updated 25 Jan 2012
|
20 Jan 2012 |
Regulatory Status
|
Bristol-Myers Squibb and AstraZeneca receive a complete response letter from the FDA for dapagliflozin in adults with type 2 diabetes mellitus [15]
Updated 20 Jan 2012
|
08 Dec 2011 |
Scientific Update
|
Efficacy and adverse events data from a phase III trial in Type 2 diabetes mellitus presented at the 21st World Diabetes Congress (IDF-2011) [96]
Updated 12 Dec 2011
|
18 Nov 2011 |
Scientific Update
|
Adverse events data from a meta-analysis of 14 phase IIb/III trials in Type 2 diabetes mellitus presented at the 84th Annual Scientific Sessions of the American Heart Association (AHA-2011) [44] , [22]
Updated 21 Nov 2011
|
31 Oct 2011 |
Phase Change - III
|
Phase-III clinical trials in Type-2 diabetes mellitus (Combination therapy) in Brazil (PO)
Updated 07 Mar 2013
|
31 Oct 2011 |
Phase Change - Preregistration
|
Preregistration for Type-2 diabetes mellitus in Mexico (PO)
Updated 07 Mar 2013
|
06 Oct 2011 |
Trial Update
|
AstraZeneca and Bristol-Myers Squibb complete a phase III trial in Type-2 diabetes mellitus in USA (NCT00984867)
Updated 18 Oct 2011
|
01 Oct 2011 |
Phase Change - III
|
Phase-III clinical trials in Type-2 diabetes mellitus (combination therapy) in Czech Republic (PO)
Updated 01 Nov 2011
|
01 Oct 2011 |
Trial Update
|
AstraZeneca and Bristol-Myers Squibb initiate enrolment in a phase III trial for Type-2 diabetes mellitus (second-line therapy in metformin/sulfonylurea failures) in Canada (NCT01392677)
Updated 01 Nov 2011
|
16 Sep 2011 |
Scientific Update
|
Efficacy data from a phase II trial in Type-2 diabetes mellitus presented at the 47th Annual meeting of the European Association for the Study of Diabetes (EASD-2011) [210]
Updated 27 Sep 2011
|
16 Sep 2011 |
Scientific Update
|
Adverse events data from the pooled analysis of 12 trials presented at the 47th Annual Meeting of the European Association for the Study of Diabetes (EASD-2011) [211]
Updated 26 Sep 2011
|
16 Sep 2011 |
Scientific Update
|
Final efficacy and adverse events data from a phase III trial (NCT00683878) in Type-2 diabetes mellitus (Combination therapy) presented at the 47th Annual meeting of the European Association for the Study of Diabetes (EASD-2011) [212]
Updated 26 Sep 2011
|
13 Sep 2011 |
Trial Update
|
AstraZeneca and Bristol-Myers Squibb complete enrolment in their phase III trial for Type-2 diabetes mellitus (monotherapy) in Japan (NCT01294423)
Updated 06 Oct 2011
|
13 Sep 2011 |
Trial Update
|
AstraZeneca and Bristol-Myers Squibb complete enrolment in a phase III trial for Type-2 diabetes mellitus in Japan (NCT01294436)
Updated 04 Oct 2011
|
30 Aug 2011 |
Trial Update
|
AstraZeneca and Bristol-Myers Squibb complete a phase III trial in Type 2 diabetes mellitus (in combination with metformin) in Germany, Hungary, Romania, Slovakia, South Africa, Switzerland, and the Ukraine (NCT01217892)
Updated 16 Sep 2011
|
30 Aug 2011 |
Trial Update
|
AstraZeneca and Bristol-Myers Squibb complete enrolment in their phase III trial for Type 2 diabetes mellitus in China, India, South Korea and Taiwan (NCT01095653)
Updated 16 Sep 2011
|
20 Jul 2011 |
Regulatory Status
|
FDA's Endocrinologic and Metabolic Drugs Advisory Committee recommends against approval of dapagliflozin for Type-2 diabetes mellitus in USA [18]
Updated 22 Jul 2011
|
30 Jun 2011 |
Phase Change - Preregistration
|
Preregistration for Type-2 diabetes mellitus in Russia (PO)
Updated 07 Mar 2013
|
27 Jun 2011 |
Scientific Update
|
Efficacy and adverse events data from two 24-week phase III trials in Type 2 diabetes mellitus presented at the 71st Annual Scientific Sessions of the American Diabetes Assocation (ADA-2011) [85]
Updated 03 Jul 2011
|
27 Jun 2011 |
Scientific Update
|
Long-term efficacy and adverse events data from two phase III trials in type 2 diabetes mellitus presented at the 71st Annual Scientific Sessions of the American Diabetes Association (ADA-2011) [213] , [214] , [82]
Updated 02 Jul 2011
|
01 Jun 2011 |
Trial Update
|
AstraZeneca and Bristol-Myers-Squibb complete a phase II/III trial in Type-2 diabetes mellitus (with moderate renal impairment) in USA, Argentina, Australia, Canada, Denmark, France, India, Italy, Mexico, Peru, Puerto Rico, Singapore and Spain (NCT00663260)
Updated 10 May 2017
|
31 May 2011 |
Phase Change - Preregistration
|
Preregistration for Type-2 diabetes mellitus in New Zealand (PO)
Updated 07 Mar 2013
|
31 May 2011 |
Phase Change - Preregistration
|
Preregistration for Type-2 diabetes mellitus in Ukraine (PO)
Updated 07 Mar 2013
|
12 Apr 2011 |
Trial Update
|
Suspension lifted and enrolment completed in a phase III trial (in combination with metformin) for Type-2 diabetes mellitus in Germany, Hungary, Romania, Slovakia, South Africa, Switzerland, and the Ukraine (NCT01217892)
Updated 02 May 2011
|
31 Mar 2011 |
Phase Change - Preregistration
|
Preregistration for Type-2 diabetes mellitus in Chile (PO)
Updated 07 Mar 2013
|
31 Mar 2011 |
Phase Change - Preregistration
|
Preregistration for Type-2 diabetes mellitus in South Africa (PO)
Updated 07 Mar 2013
|
23 Mar 2011 |
Phase Change - III
|
Phase-III clinical trials in Type-2 diabetes mellitus (monotherapy and combination therapy) in Japan (PO)
Updated 04 Apr 2011
|
16 Mar 2011 |
Trial Update
|
Enrolment suspended in a phase III trial (in combination with metformin) for Type-2 diabetes mellitus in Germany, Hungary, Romania, Slovakia, South Africa, Switzerland, and the Ukraine (NCT01217892)
Updated 28 Mar 2011
|
28 Feb 2011 |
Phase Change - Preregistration
|
Preregistration for Type-2 diabetes mellitus in Brazil (PO)
Updated 07 Mar 2013
|
28 Feb 2011 |
Phase Change - Preregistration
|
Preregistration for Type-2 diabetes mellitus in Switzerland (PO)
Updated 07 Mar 2013
|
28 Feb 2011 |
Phase Change - III
|
Phase-III clinical trials in Type-2 diabetes mellitus (monotherapy) in Japan (PO)
Updated 17 Jun 2011
|
31 Jan 2011 |
Phase Change - Preregistration
|
Preregistration for Type-2 diabetes mellitus in Canada (PO)
Updated 07 Mar 2013
|
06 Jan 2011 |
Trial Update
|
Bristol-Myers Squibb completes a phase I trial (NCT01068756) in Type-2 diabetes mellitus in USA
Updated 14 Jan 2011
|
31 Dec 2010 |
Phase Change - Preregistration
|
Preregistration for Type-2 diabetes mellitus in USA (PO)
Updated 10 Jun 2013
|
31 Dec 2010 |
Phase Change - Preregistration
|
Preregistration for Type-2 diabetes mellitus (Combination therapy) in European Union (PO)
Updated 12 Nov 2012
|
31 Dec 2010 |
Phase Change - Preregistration
|
Preregistration for Type-2 diabetes mellitus (Monotherapy in metformin-intolerant patients) in European Union (PO)
Updated 23 Apr 2012
|
31 Dec 2010 |
Phase Change - Preregistration
|
Preregistration for Type-2 diabetes mellitus (Combination therapy) in USA (PO)
Updated 11 Feb 2011
|
20 Dec 2010 |
Trial Update
|
Bristol-Myers Squibb completes a phase III trial (NCT00528372) in Type 2 diabetes mellitus (not well controlled with diet and exercise) in the US, Canada, Latin America (Mexico) and Europe (Russia)
Updated 03 Jan 2011
|
02 Dec 2010 |
Trial Update
|
AstraZeneca and Bristol-Myers Squibb completes enrolment in its phase III trial (NCT01042977) for Type-2 diabetes mellitus in USA, Argentina, Australia, Austria, Bulgaria, Canada, Chile, Germany, Hungary and Poland
Updated 23 Dec 2010
|
30 Nov 2010 |
Trial Update
|
Bristol-Myers Squibb and AstraZeneza complete a phase II trial (NCT00976495) in Type 2 Diabetes Mellitus in US, Canada and Netherlands
Updated 18 Jan 2011
|
15 Nov 2010 |
Phase Change - III
|
Phase-III clinical trials in Type-2 diabetes mellitus in South Africa (PO)
Updated 14 Dec 2010
|
15 Nov 2010 |
Phase Change - III
|
Phase-III clinical trials in Type-2 diabetes mellitus in Ukraine (PO)
Updated 14 Dec 2010
|
15 Nov 2010 |
Trial Update
|
AstraZeneca and Bristol-Myers Squibb initiates enrolment in a phase III trial for Type-2 diabetes mellitus in Germany, Hungary, Romania, Slovakia, South Africa, Switzerland and the Ukraine [NCT01217892]
Updated 14 Dec 2010
|
09 Nov 2010 |
Trial Update
|
Bristol-Myers Squibb and AstraZeneca initiate enrolment in a phase III trial (NCT01195662) for Type-2 diabetes mellitus in USA
Updated 08 Dec 2010
|
09 Nov 2010 |
Trial Update
|
Bristol-Myers Squibb completes enrolment in its phase I trial (NCT01165268) for Type-2 diabetes mellitus in USA
Updated 08 Dec 2010
|
12 Oct 2010 |
Trial Update
|
AstraZeneca and Bristol-Myers Squibb complete enrolment in their phase II pharmacodynamics trial (NCT00976495) for Type 2 diabetes mellitus in USA, Canada and the Netherlands
Updated 29 Oct 2010
|
05 Oct 2010 |
Trial Update
|
Bristol-Myers Squibb initiates enrolment in a phase I trial investigating the kinetics of renal glucose reabsorption during dapagliflozin therapy in USA
Updated 15 Oct 2010
|
24 Sep 2010 |
Scientific Update
|
Final adverse events and efficacy data from a phase III trial of dapagliflozin combination therapy with metformin for Type 2 diabetes mellitus released by AstraZeneca and Bristol-Myers Squibb [83]
Updated 30 Sep 2010
|
20 Sep 2010 |
Scientific Update
|
Efficacy and adverse events data from a phase III trial in type 2 diabetes mellitus presented at the 46th Annual Meeting of the European Association for the Study of Diabetes (EASD-2010) [97] , [215] , [98]
Updated 21 Sep 2010
|
11 Aug 2010 |
Trial Update
|
Bristol-Myers Squibb initiates enrolment in a phase III trial (NCT01137474) for Type-2 diabetes mellitus in USA
Updated 27 Aug 2010
|
01 Aug 2010 |
Trial Update
|
AstraZeneca and Bristol-Myers Squibb complete a phase II trial evaluating pharmacodynamics of dapagliflozin in patients with type 2 diabetes
Updated 15 Oct 2010
|
28 Jul 2010 |
Trial Update
|
BMS and AstraZeneca complete a phase III trial [NCT00683878] in Type-2 diabetes mellitus (Combination therapy) in USA, Canada, Latin America, India, Taiwan, Phillipines
Updated 09 Sep 2010
|
09 Jul 2010 |
Trial Update
|
AstraZeneca and Bristol-Myers squibb complete enrolment in their phase III trial (NCT00984867) for Type 2 diabetes mellitus in USA, Argentina, Germany, Mexico, Poland and United Kingdom
Updated 28 Jul 2010
|
30 Jun 2010 |
Phase Change - III
|
Phase-III clinical trials for Type-2 diabetes mellitus (Monotherapy) in India (PO)
Updated 10 Jun 2013
|
30 Jun 2010 |
Phase Change - III
|
Phase-III clinical trials in Type-2 diabetes mellitus (Monotherapy) in China (PO)
Updated 22 Jul 2010
|
30 Jun 2010 |
Phase Change - III
|
Phase-III clinical trials in Type-2 diabetes mellitus (Monotherapy) in South Korea (PO)
Updated 22 Jul 2010
|
30 Jun 2010 |
Phase Change - III
|
Phase-III clinical trials in Type-2 diabetes mellitus (Monotherapy) in Taiwan (PO)
Updated 22 Jul 2010
|
30 Jun 2010 |
Phase Change - III
|
Phase-III clinical trials in Type-2 diabetes mellitus (Combination therapy) in China (PO)
Updated 22 Jul 2010
|
30 Jun 2010 |
Trial Update
|
BMS initiates enrolment in a phase III trial of dapagliflozin monotherapy for Type 2 diabetes mellitus in China, India, South Korea and Taiwan
Updated 22 Jul 2010
|
30 Jun 2010 |
Trial Update
|
BMS initiates enrolment in a phase III trial of dapagliflozin in combination with metformin in China, India and South Korea (NCT01095666)
Updated 22 Jul 2010
|
29 Jun 2010 |
Trial Update
|
Bristol-Myers Squibb and AstraZeneca completes a phase III trial in Type-2 diabetes mellitus (in combination with extended-release metformin) in USA, India, South Korea, Mexico, Puerto Rico and Russia (NCT00859898)
Updated 15 Jul 2010
|
29 Jun 2010 |
Trial Update
|
Bristol-Myers Squibb and AstraZeneca complete a phase I (NCT01135446) trial in healthy subjects in USA (PO, tablet and liquid)
Updated 06 Jul 2010
|
26 Jun 2010 |
Scientific Update
|
Efficacy data from a phase III trial (NCT00673231) in Type-2 diabetes mellitus presented at the 70th Annual Scientific Sessions of the American Diabetes Association (ADA-2010) [216]
Updated 29 Jun 2010
|
23 Jun 2010 |
Scientific Update
|
Final efficacy data from a phase III monotherapy trial in treatment-naive patients with Type-2 diabetes released by Bristol-Myers Squibb [217]
Updated 23 Jun 2010
|
28 May 2010 |
Trial Update
|
Bristol-Myers Squibb initiates enrolment in a phase I trial in Healthy volunteers in USA
Updated 03 Jun 2010
|
27 May 2010 |
Phase Change - I
|
Phase-I clinical trials in Type-2 diabetes mellitus in USA (PO, Liquid)
Updated 06 Jul 2010
|
27 May 2010 |
Trial Update
|
Bristol-Myers Squibb and AstraZeneca initiate enrolment in a phase I trial (NCT01135446) in healthy subjects in USA (PO, tablet and liquid)
Updated 06 Jul 2010
|
21 May 2010 |
Trial Update
|
Bristol-Myers Squibb completes a Phase-III trial [NCT00528879] in Type 2 diabetes mellitus in USA, Canada and Latin America
Updated 11 Jul 2010
|
14 May 2010 |
Trial Update
|
AstraZeneca and Bristol-Myers Squibb completes a phase II trial (NCT00972244) in Type-2 diabetes mellitus in Japan
Updated 21 May 2010
|
22 Apr 2010 |
Trial Update
|
BMS and AstraZeneca complete a phase I trial in healthy volunteers in Germany
Updated 10 May 2010
|
31 Mar 2010 |
Trial Update
|
AstraZeneca/BMS initiates enrolment in a world-wide phase III trial for patients with diabetes and cardiovascular disease (NCT01042977)
Updated 22 Mar 2012
|
31 Mar 2010 |
Phase Change - III
|
Phase-III clinical trials in Type-2 diabetes mellitus (Combination therapy) in Argentina (PO)
Updated 23 Dec 2010
|
31 Mar 2010 |
Phase Change - III
|
Phase-III clinical trials in Type-2 diabetes mellitus in Australia (PO)
Updated 23 Dec 2010
|
31 Mar 2010 |
Phase Change - III
|
Phase-III clinical trials in Type-2 diabetes mellitus in Chile (PO)
Updated 23 Dec 2010
|
16 Mar 2010 |
Trial Update
|
AstraZeneca & Bristol-Myers Squibb complete enrolment in their phase I trial for Type-2 diabetes mellitus in Germany (PO, twice-daily dosing)
Updated 29 Mar 2010
|
28 Feb 2010 |
Trial Update
|
AstraZeneca/BMS initiates enrolment in a world-wide phase III trial for patients with diabetes as well as cardiovascular disease and hypertension (NCT01031680)
Updated 22 Mar 2012
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19 Feb 2010 |
Phase Change - I
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Phase-I clinical trials in Type-2 diabetes mellitus in Germany (PO, twice-daily dosing)
Updated 08 Mar 2010
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01 Feb 2010 |
Trial Update
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AstraZeneca & Bristol-Myers Squibb complete enrolment in their phase III trial (NCT01031680) for Type-2 diabetes mellitus in USA, Argentina, Canada, Germany, Romania, Slovakia, Spain, Taiwan and Vietnam
Updated 29 Dec 2010
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04 Nov 2009 |
Trial Update
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AstraZeneca and Bristol-Myers Squibb initiate enrolment in their phase II pharmacodynamics trial (NCT00976495) for Type 2 diabetes mellitus in USA, Canada and the Netherlands
Updated 29 Oct 2010
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02 Oct 2009 |
Scientific Update
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Final pharmacodynamics data from two preclinical studies in Type -2 diabetes mellitus presented at the 45th Annual Meeting of the European Association for the Study of Diabetes (EASD-2009) [218] , [219]
Updated 07 Oct 2009
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02 Oct 2009 |
Scientific Update
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Efficacy and tolerability data from a phase II/III trial in Type-2 diabetes mellitus presented at the 45th Annual Meeting of the European Association for the Study of Diabetes (EASD-2009) [220]
Updated 06 Oct 2009
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02 Oct 2009 |
Scientific Update
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Efficacy and tolerability data from a phase III trial in Type-2 diabetes mellitus presented at the 45th Annual Meeting of the European Association for the Study of Diabetes (EASD-2009) [87] , [221]
Updated 06 Oct 2009
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11 Jun 2009 |
Scientific Update
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Preclinical pharmacodynamics data in Type-2 diabetes mellitus presented at the 91st Annual Meeting of the Endocrine Society (ENDO-2009) [222] ,
Updated 06 Jul 2009
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07 Jun 2009 |
Scientific Update
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Efficacy & adverse events data from a phase II/III trial in Type-2 diabetes mellitus presented at the 69th Annual Scientific Sessions of the American Diabetes Association (ADA-2009) [68] , [223]
Updated 15 Jun 2009
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22 Apr 2009 |
Phase Change - III
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Phase-III clinical trials in Type-2 diabetes mellitus (Monotherapy) in Puerto Rico (PO)
Updated 10 Jun 2013
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22 Apr 2009 |
Phase Change - III
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Phase-III clinical trials in Type-2 diabetes mellitus (Monotherapy) in Philippines (PO)
Updated 06 Jun 2013
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22 Apr 2009 |
Phase Change - III
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Phase-III clinical trials in Type-2 diabetes mellitus (Combination therapy) in India (PO)
Updated 15 Jul 2010
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22 Apr 2009 |
Phase Change - III
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Phase-III clinical trials in Type-2 diabetes mellitus (Combination therapy) in Mexico (PO)
Updated 15 Jul 2010
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22 Apr 2009 |
Phase Change - III
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Phase-III clinical trials in Type-2 diabetes mellitus (Combination therapy) in Puerto Rico (PO)
Updated 15 Jul 2010
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22 Apr 2009 |
Phase Change - III
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Phase-III clinical trials in Type-2 diabetes mellitus (Combination therapy) in Russia (PO)
Updated 15 Jul 2010
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22 Apr 2009 |
Phase Change - III
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Phase-III clinical trials in Type-2 diabetes mellitus (Combination therapy) in South Korea (PO)
Updated 15 Jul 2010
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22 Apr 2009 |
Phase Change - III
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Phase-III clinical trials in Type-2 diabetes mellitus (Combination therapy) in USA (PO)
Updated 15 Jul 2010
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10 Dec 2008 |
Licensing Status
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Bristol-Myers Squibb and AstraZeneca expand their collaboration to develop and commercialise dapagliflozin in Japan [5]
Updated 10 Dec 2008
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10 Dec 2008 |
Phase Change - II
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Phase-II clinical trials in Type-2 diabetes mellitus in Japan (PO)
Updated 10 Dec 2008
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20 Oct 2008 |
Trial Update
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AstraZeneca and Bristol-Myers Squibb completes enrolment in its phase III trial for Type-2 diabetes mellitus in Argentina, France, Germany, Italy, Mexico, the Netherlands, South Africa, Spain, Sweden and the United Kingdom (NCT00660907)
Updated 06 Sep 2011
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11 Sep 2008 |
Scientific Update
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Interim efficacy data from a phase III trial in Type 2 diabetes presented at the 44th Annual Meeting of the European Association for the Study of Diabetes (EASD-2008) [224] , [225]
Updated 18 Sep 2008
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05 Aug 2008 |
Phase Change - III
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Phase-III clinical trials in Type-2 diabetes mellitus (Combination therapy) in Canada (PO)
Updated 09 Sep 2010
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05 Aug 2008 |
Phase Change - III
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Phase-III clinical trials in Type-2 diabetes mellitus (Combination therapy) in Latin America (Argentina, Mexico and Peru) (PO)
Updated 09 Sep 2010
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05 Aug 2008 |
Phase Change - III
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Phase-III clinical trials in Type-2 diabetes mellitus (Combination therapy) in Philippines (PO)
Updated 09 Sep 2010
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05 Aug 2008 |
Phase Change - III
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Phase-III clinical trials in Type-2 diabetes mellitus (Combination therapy) in Taiwan (PO)
Updated 09 Sep 2010
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05 Aug 2008 |
Phase Change - III
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Phase-III clinical trials in Type-2 diabetes mellitus (Combination therapy) in USA (PO)
Updated 09 Sep 2010
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10 Jun 2008 |
Scientific Update
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Final efficacy and adverse events data from Phase-II trials in Type 2 diabetes mellitus presented at the 68th Scientific Sessions of the American Diabetes Association (ADA-2008) [226] , [227]
Updated 30 Jun 2008
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01 Jun 2008 |
Trial Update
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AstraZeneca and Bristol-Myers-Squibb initiate a phase II/III trial in Type-2 diabetes mellitus (with moderate renal impairment) in USA, Argentina, Australia, Canada, Denmark, France, India, Italy, Mexico, Peru, Puerto Rico, Singapore and Spain (NCT00663260)
Updated 10 May 2017
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30 Apr 2008 |
Phase Change - III
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Phase-III clinical trials in Type-2 diabetes mellitus in Russia (PO)
Updated 29 Jun 2010
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31 Oct 2007 |
Scientific Update
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Data presented at the 2007 Annual Meeting of the North American Association for the Study of Obesity (NAASO-2007) added to the Diabetes pharmacodynamics section [228]
Updated 31 Oct 2007
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01 Oct 2007 |
Phase Change - I
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Phase-I clinical trials in Type-2 diabetes mellitus in Japan (PO)
Updated 13 Jun 2008
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28 Sep 2007 |
Scientific Update
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Data presented at the 43rd Annual Meeting of the European Association for the Study of Diabetes (EASD-2007) added to the adverse events, pharmacokinetics and Diabetes pharmacodynamics section [229] , [230]
Updated 28 Sep 2007
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11 Sep 2007 |
Phase Change - III
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Phase-III clinical trials in Type-2 diabetes mellitus in European Union (PO)
Updated 13 Jun 2008
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26 Jul 2007 |
Phase Change - II/III
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Phase-II/III clinical trials in Type-2 diabetes mellitus in India (PO)
Updated 10 Dec 2008
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26 Jul 2007 |
Phase Change - II/III
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Phase-II/III clinical trials in Type-2 diabetes mellitus in Israel (PO)
Updated 10 Dec 2008
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26 Jul 2007 |
Phase Change - II/III
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Phase-II/III clinical trials in Type-2 diabetes mellitus in Singapore (PO)
Updated 10 Dec 2008
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26 Jul 2007 |
Phase Change - III
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Phase-III clinical trials in Type-2 diabetes mellitus in Canada (PO)
Updated 13 Jun 2008
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26 Jul 2007 |
Phase Change - III
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Phase-III clinical trials in Type-2 diabetes mellitus in Latin America (PO)
Updated 13 Jun 2008
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26 Jul 2007 |
Phase Change - III
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Phase-III clinical trials in Type-2 diabetes mellitus in USA (PO)
Updated 30 Jul 2007
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02 Jul 2007 |
Scientific Update
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Data presented at the 67th Scientific Sessions of the American Diabetes Association (ADA-2007) added to the adverse events and Diabetes therapeutic trials sections [231]
Updated 02 Jul 2007
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15 Nov 2006 |
Phase Change - II
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Phase-II clinical trials in Type-2 diabetes mellitus in USA (unspecified route)
Updated 21 Dec 2006
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23 Nov 2004 |
Phase Change - I/II
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Phase-I/II clinical trials in Type-2 diabetes mellitus in USA (unspecified route)
Updated 23 Nov 2004
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