drugset / Trial / NCT00789035
12 Weeks Treatment With 3 Different Doses of BI 10773 in Type 2 Diabetic Patients
Parallel-groupTreatment
Summary
The objective is to investigate the efficacy, safety and pharmacokinetics of three different doses of BI 10773 compared to placebo given for 12 weeks in patients with type 2 diabetes mellitus with insufficient glycemic control. In addition an open-label metformin arm will be assessed
Timeline
- Start
- 2008-10
- Primary completion
- 2009-10
- Completion
- —
Outcome
Met primary endpoint
registry analysis (superiority or other test); Placebo vs Empagliflozin 5 mg; p <0.0001; Mean Difference (Final Values) -0.52 (95% CI -0.74 to -0.29); ANCOVA; NCT00789035 ↗
Publications
- Tuttle KR, Levin A, Nangaku M, Kadowaki T, Agarwal R, Hauske SJ, Elsasser A, Ritter I, Steubl D, Wanner C, Wheeler DC. Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. Diabetes Care. 2022 Jun 2;45(6):1445-1452. doi: 10.2337/dc21-2034.
- Riggs MM, Staab A, Seman L, MacGregor TR, Bergsma TT, Gastonguay MR, Macha S. Population pharmacokinetics of empagliflozin, a sodium glucose cotransporter 2 inhibitor, in patients with type 2 diabetes. J Clin Pharmacol. 2013 Oct;53(10):1028-38. doi: 10.1002/jcph.147. Epub 2013 Aug 13.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Empagliflozin | Small molecule | 5 mg | Oral |
| Subject | Empagliflozin | Small molecule | 10 mg | Oral |
| Subject | Empagliflozin | Small molecule | 25 mg | Oral |
| Subject | Metformin | Small molecule | — | — |