Extension to a Study on the 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

This is an 80-week extension to a study 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. The purpose of the extension study is to gather data on the long-term safety and effectiveness of vildagliptin in people with type 2 diabetes.

Key facts

Study ID

NCT00138619

Run by

Novartis

People needed

478

Starts

2004-11-01

Expected to finish

2007-04-01

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…

• Only patients successfully completing study CLAF237A2327 are eligible
• Written informed consent
• Ability to comply with all study requirements

You may not qualify if…

• Premature discontinuation from study CLAF237A2327
• Other protocol-defined exclusion criteria may apply

Where it is running

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

Full record on ClinicalTrials.gov

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