drugset / Trial / NCT01719003
Safety and Efficacy Study of Empagliflozin and Metformin for 24 Weeks in Treatment Naive Patients With Type 2 Diabetes
RandomizedParallel-groupDouble-blindTreatment
Summary
This study will investigate the efficacy and safety of two doses (high and low) of empagliflozin in combination with metformin (500 mg and 1000 mg) administered twice daily in patients with type 2 diabetes mellitus (T2DM). Study will compare four dose combinations of empagliflozin + metformin versus each individual component after 24 weeks of treatment.
Timeline
- Start
- 2012-10
- Primary completion
- 2014-11
- Completion
- 2014-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Empagliflozin | Small molecule | 5 mg | Oral |
| Subject | Empagliflozin | Small molecule | 10 mg | Oral |
| Subject | Empagliflozin | Small molecule | 12.5 mg | Oral |
| Subject | Empagliflozin | Small molecule | 25 mg | Oral |
| Subject | Metformin | Small molecule | 500 mg | Oral |
| Subject | Metformin | Small molecule | 1000 mg | Oral |