Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

A Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Dapagliflozin as an Add-on to Insulin Therapy in Subjects With Type 1 Diabetes Mellitus

Next Previous
X
Search
Trial Profile

A Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Dapagliflozin as an Add-on to Insulin Therapy in Subjects With Type 1 Diabetes Mellitus

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 14 Apr 2022

Price :

$35 *

Note:
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs Dapagliflozin (Primary)
  • Indications Type 1 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Acronyms DEPICT 1
  • Sponsors AstraZeneca; Bristol-Myers Squibb

    • Most Recent Events

    • 10 Apr 2022 Data from three studies (phase 2 (NCT01498185) and two phase 3 (DEPICT-1, NCT02268214; DEPICT-2, NCT02460978) studies) were used to characterize the dapagliflozin pharmacokinetics (PK) in patients with T1DM published in the Journal of Clinical Pharmacology
    • 06 Nov 2019 Results of two studies (DEPICT-1 & DEPICT-2) assessing impact of dapagliflozin on patient-reported treatment satisfaction, presented at the 22nd Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research.
    • 15 Jul 2019 According to an AstraZeneca media release, the US Food and Drug Administration (FDA) has issued a complete response letter regarding the supplemental New Drug Application for Farxiga (dapagliflozin) as an adjunct treatment to insulin to improve glycaemic control in adult patients with type-1 diabetes (T1D), when insulin alone does not provide adequate glycaemic control. The company will work closely with the FDA to discuss the next steps.

You need to be a logged in or subscribed to view this content Request demo

If your organization or you do not have a subscription, try one of the following:
  • Contacting your organization’s admin about adding this content to your AdisInsight subscription
  • Buying a PDF version of any individual profile
  • Request a free trial
If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top