A Phase II, Randomised, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Once Daily Oral Administration of BI 10773 for 28 Days in Japanese Patients With Type 2 Diabetes Mellitus.
Phase of Trial: Phase II
Latest Information Update: 01 Apr 2018
At a glance
- Drugs Empagliflozin (Primary)
- Indications Type 2 diabetes mellitus
- Focus Therapeutic Use
- Sponsors Boehringer Ingelheim
- 01 Apr 2018 Results of post hoc analysis assessing changes in 24-h urine volume, fluid intake, and fluid balance in Japanese patients published in the Diabetes Therapy
- 15 Sep 2017 Results of pooled analysis assessing safety of this and other phase I-III studies , presented at the 53rd Annual Meeting of the European Association for the Study of Diabetes.
- 15 Sep 2017 Results of pooled safety analysis in >12,000 patients who were randomized to Empagliflozin (10 mg, 25 mg) or placebo in 15 Phase I-III trials plus 4 extension studies, presented at the 53rd Annual Meeting of the European Association for the Study of Diabetes.