drugset / Trial / NCT01811485
Study of Efficacy and Safety LMF237 in Patients With Type 2 Diabetes Mellitus (T2DM) Inadequately Controlled With Vildagliptin Monotherapy
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of the study was to evaluate the efficacy and safety of LMF237 50/250 mg and 50/500 mg bid in Japanese patients with T2DM inadequately controlled with vildagliptin monotherapy. This study was conducted to support registration of the fixed-dose combination of vildagliptin and metformin for the treatment of T2DM in Japan.
Timeline
- Start
- 2013-05
- Primary completion
- 2014-02
- Completion
- 2014-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Metformin | Small molecule | 250 mg | — |
| Subject | Metformin | Small molecule | 500 mg | — |
| Subject | Vildagliptin | Other / unclassified | 50 mg | — |