Efficacy and Safety of Vildagliptin in Combination With Pioglitazone in Drug Naive Patients With Type 2 Diabetes
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Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. The purpose of this study is to assess the safety and effectiveness of the combination of vildagliptin, an unapproved drug, and pioglitazone in lowering overall blood glucose levels in people with type 2 diabetes who have not previously been treated with drug therapy to lower their blood sugar.
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Ages Eligible for Study:
18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Not previously treated with oral antidiabetic agents as defined by the protocol
Blood glucose criteria must be met
Body mass index (BMI) in the range 22-45
Pregnancy or lactation
Type 1 diabetes
Evidence of serious diabetic complications
Evidence of serious cardiovascular complications
Laboratory value abnormalities as defined by the protocol
Known sensitivity to pioglitazone
Other protocol-defined exclusion criteria may apply