Extension to a Study of the Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes With Hemoglobin A1c (HbA1c) 9-11%
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.
Read our disclaimer for details.
This study is not being conducted in the United States. This is a 52-week extension to a study to assess the safety and effectiveness of two doses of vildagliptin, an unapproved drug, in lowering overall blood glucose levels in people with type 2 diabetes who had not previously been treated with drug therapy to lower their blood sugar and whose blood sugar levels were in a specified range. The purpose of the extension study is to gather data on the long term safety and effectiveness of vildagliptin in people with type 2 diabetes.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Only patients successfully completing study CLAF237A2329 are eligible
Written informed consent
HbA1c reduction from baseline to week 12 (visit 5) of the core study is greater than or equal to 0.3 absolute units
Ability to comply with all study requirements
Premature discontinuation from study CLAF237A2329
Other protocol-defined exclusion criteria may apply