Vildagliptin Compared to Pioglitazone 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 long-term safety and effectiveness of vildagliptin, an unapproved drug, compared to that of pioglitazone in lowering overall blood glucose levels when added to metformin in people with type 2 diabetes not at target blood glucose levels on metformin alone.

Key facts

Study ID

NCT00237237

Run by

Novartis

People needed

588

Starts

2005-10-01

Last updated by the study team

2017-02-07

Who can join

Age: 18 and older, up to 77. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• On a stable dose of metformin 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…

• History of type 1 diabetes
• Pregnancy or lactation
• Evidence of significant diabetic complications
• Serious cardiovascular events within the past 6 months
• 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
• Investigative Centers — Nuremberg, 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.