Extension to a Study on the Efficacy and Safety of Vildagliptin Compared to Metformin in Drug Naive Patients With Type 2 Diabetes

Completed · Phase 3

Conditions studied: Diabetes Mellitus, Type 2

In brief

This is a 52-week extension to a study to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to metformin in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously 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

NCT00138567

Run by

Novartis

People needed

530

Starts

2005-01-01

Expected to finish

2006-08-01

Last updated by the study team

2016-11-18

Who can join

Age: 18 and older, up to 78. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Only patients successfully completing study CLAF237A2309 are eligible
• Written informed consent
• Ability to comply with all study requirements

You may not qualify if…

• Premature discontinuation from CLAF237A2309
• Other protocol-defined exclusion criteria may apply

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.