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A Rapid Onset and Short Duration Insulin Secretogogue, Mitiglinide, in Combination With Metformin Versus Metformin Alone in Patients With Type 2 Diabetes Mellitus: A Randomized, Double-blind, Placebo-controlled Trial for 6 Months
The primary objective of this study is to demonstrate whether mitiglinide administered in combination with metformin is more effective than metformin alone in patients with Type 2 diabetes mellitus (T2DM) whose blood sugar is not well controlled taking metformin alone. This is a 24 week study which measures improvement in blood sugar after of treatment.
Details
| Lead sponsor | Elixir Pharmaceuticals |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 367 |
| Start date | 2007-08 |
| Completion | 2008-10 |
Conditions
- Diabetes Mellitus, Type 2
Interventions
- placebo for mitiglinide
- mitiglinide
- mitiglinide
Primary outcomes
- change from baseline in HbA1c — after 24 weeks of treatment
Countries
United States, Puerto Rico