Efficacy and Safety of Vildagliptin Compared to Placebo in Patients With Type 2 Diabetes and Mild Hyperglycemia
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. Key long-term clinical studies have shown that people with type 2 diabetes should try to achieve overall blood glucose levels as close to normal as possible. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to placebo in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar and whose blood glucose levels are close to normal.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Blood glucose criteria must be met
Not currently on drug therapy for type 2 diabetes
Body mass index (BMI) in the range 22-45
Diagnosis of type 2 diabetes for at least 8 weeks
Pregnancy or lactation
Type 1 diabetes
Evidence of serious diabetic complications
Evidence of serious cardiovascular complications
Significant laboratory abnormalities as defined by the protocol
Other protocol-defined exclusion criteria may apply