Vildagliptin Compared to Glimepiride in Combination With Metformin 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 long term safety and effectiveness of vildagliptin, an unapproved drug, compared to that of glimepiride 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.

Key facts

Study ID

NCT00106340

Run by

Novartis Pharmaceuticals

People needed

3118

Starts

2005-03-01

Expected to finish

2008-05-20

Last updated by the study team

2020-12-17

Who can join

Age: 18 and older, up to 73. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• On a stable dose of metformin as defined by the protocol
• Body mass index (BMI) in the range 22-45
• Blood glucose criteria must be met

You may not qualify if…

• 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

Where it is running

• Novartis Pharmaceuticals — East Hanover, New Jersey, United States
• Investigative Centers — Nuremberg, Germany

Full record on ClinicalTrials.gov

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