Efficacy and Safety of Vildagliptin in Combination With Pioglitazone in Drug Naive Patients With Type 2 Diabetes

Completed · Phase 3

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 the combination of vildagliptin, an unapproved drug, and pioglitazone in lowering overall blood glucose levels in people with type 2 diabetes who have not previously been treated with drug therapy to lower their blood sugar.

Key facts

Study ID

NCT00101803

Run by

Novartis Pharmaceuticals

People needed

527

Starts

2005-01-01

Expected to finish

2006-01-01

Last updated by the study team

2017-05-17

Who can join

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

You may qualify if…

• Not previously treated with oral antidiabetic agents as defined by the protocol
• Blood glucose criteria must be met
• Body mass index (BMI) in the range 22-45

You may not qualify if…

• Pregnancy or lactation
• Type 1 diabetes
• Evidence of serious diabetic complications
• Evidence of serious cardiovascular 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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