Vildagliptin Compared to Gliclazide in Combination With Metformin in Patients With Type 2 Diabetes
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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This study is not being conducted in the United States. 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 vildagliptin, an unapproved drug, compared to that of gliclazide in lowering overall blood glucose levels when added to metformin in people with type 2 diabetes not at target blood glucose levels on metformin alone.
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Ages Eligible for Study:
18 Years to 78 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
On a stable dose of metformin 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 significant diabetic complications
Evidence of serious cardiovascular complications
Laboratory value abnormalities as defined by the protocol
Other protocol-defined exclusion criteria may apply