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A Phase III, Double-blind, Placebo Controlled, Monotherapy Study of MP-513 in Japanese Patients With Type 2 Diabetes Mellitus - Confirmative Study
The purpose of this study is to evaluate the efficacy and safety of MP-513 (Teneligliptin) in patients with type 2 Diabetes for 12 weeks administration.
Details
| Lead sponsor | Tanabe Pharma Corporation |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 203 |
| Start date | 2009-09 |
| Completion | 2010-06 |
Conditions
- Type 2 Diabetes Mellitus
Interventions
- Teneligliptin 20 mg
- Placebo
Primary outcomes
- Change From Baseline in HbA1c at Week 12 — 12 weeks
The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline HbA1c as a covariate.
Countries
Japan