Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. This is a 28-week extension to a study to assess the safety and effectiveness of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to metformin in people with type 2 diabetes who are not at target blood glucose levels on metformin alone. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
418
Novartis Pharmaceuticals
East Hanover, New Jersey, United States
Safety of vildagliptin in combination with metformin during 52 weeks of treatment
Change from baseline in HbA1c at 52 weeks
Change in HbA1c between 24 weeks and 52 weeks
Change from baseline in fasting plasma glucose at 52 weeks
Change in fasting plasma glucose between 24 weeks and 52 weeks
Change from baseline in HOMA B at 52 weeks
Change from baseline in HOMA IR at 52 weeks
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