A Sub-study to LMF237A2302 to Assess the Effect of 24 Weeks Treatment With Initial Combination of Vildagliptin Plus Metformin
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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.
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
Actual Study Start Date
March 6, 2007
Actual Primary Completion Date
June 6, 2008
Actual Study Completion Date
June 6, 2008
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Ages Eligible for Study:
18 Years to 78 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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.