A Sub-study to LMF237A2302 to Assess the Effect of 24 Weeks Treatment With Initial Combination of Vildagliptin Plus Metformin
| Status: | Completed |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 78 |
| Updated: | 8/3/2017 |
| Start Date: | March 6, 2007 |
| End Date: | June 6, 2008 |
A Multicenter, Open-label Sub-study to LMF237A2302 to Assess the Effect of 24 Weeks Treatment With Initial Combination of Vildagliptin 100mg qd Plus Metformin 1000mg Bid in Drug Naive Patients With Type 2 Diabetes With Very Poor Glycemic Control
This study will evaluate the effects of treatment with vildagliptin and metformin as initial
combination in newly diagnosed patients with type 2 diabetes who have very high levels of
HbA1c and/or fasting plasma glucose.
combination in newly diagnosed patients with type 2 diabetes who have very high levels of
HbA1c and/or fasting plasma glucose.
Inclusion Criteria:
- Male or female (non-fertile or of childbearing potential using a medically approved
birth control method) patients with type 2 diabetes
- Diagnosis of type 2 diabetes for at least 4 weeks prior to study entry
- Body mass index 22-40 kg/meter squared
- HbA1c > 11% and/or FPG >270 mg/dL
Exclusion Criteria:
- Pregnant or lactating female
- History of type 1 diabetes
- Evidence of significant diabetic complications
- Treatment with insulin or any other oral antidiabetic agent
Other protocol-defined inclusion/exclusion criteria may apply.
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