Efficacy and Safety of Vildagliptin in Combination With Glimepiride in Patients With Type 2 Diabetes

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

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 two doses of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to glimepiride in people with type 2 diabetes not at target blood glucose levels on a sulfonylurea alone.

Key facts

Study ID

NCT00099944

Run by

Novartis Pharmaceuticals

People needed

515

Starts

2004-05-01

Expected to finish

2005-10-01

Last updated by the study team

2012-05-07

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Blood glucose criteria must be met
• Previously treated with a sulfonylurea for at least 3 months
• Body mass index (BMI) in the range 22-45

You may not qualify if…

• Type 1 diabetes
• Pregnancy or lactation
• Evidence of serious cardiovascular complications
• Evidence of serious diabetic complications
• Laboratory value abnormalities as defined by the protocol
• Known sensitivity to glimepiride
• Other protocol-defined exclusion criteria may apply

Where it is running

• Novartis Pharmaceuticals — East Hanover, New Jersey, United States

Full record on ClinicalTrials.gov

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