Efficacy and Safety of Vildagliptin in Combination With Pioglitazone 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 vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to pioglitazone in people with type 2 diabetes not at target blood glucose levels on either pioglitazone or rosiglitazone alone.

Key facts

Study ID

NCT00099853

Run by

Novartis Pharmaceuticals

People needed

362

Starts

2004-05-01

Expected to finish

2008-01-01

Last updated by the study team

2020-12-17

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 responded, as defined by the protocol, to treatment with pioglitazone or rosiglitazone
• 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 pioglitazone
• 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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