Efficacy and Safety of Vildagliptin in Combination With Metformin in 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 two doses of vildagliptin, an unapproved drug, when added to metformin in people with type 2 diabetes who are not at target blood glucose levels on metformin alone.

Key facts

Study ID

NCT00099892

Run by

Novartis Pharmaceuticals

People needed

544

Starts

2004-05-01

Expected to finish

2005-09-01

Last updated by the study team

2017-08-02

Who can join

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

You may qualify if…

• Blood glucose criteria must be met
• On a stable dose of metformin as defined by the protocol
• Body mass index (BMI) in the range 22-45

You may not qualify if…

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

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.