Efficacy and Safety of Vildagliptin Compared to Rosiglitazone in Drug Naive Patients With Type 2 Diabetes

Completed · Phase 3

Conditions studied: Diabetes Mellitus, Type 2

In brief

The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to rosiglitazone 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

NCT00099918

Run by

Novartis Pharmaceuticals

People needed

717

Starts

2004-05-01

Expected to finish

2005-09-01

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…

• Blood glucose criteria must be met
• Not currently on drug therapy for type 2 diabetes
• 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 conditions
• 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
• Novartis Investigative Sites — Investigative Centers, Germany

Full record on ClinicalTrials.gov

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