Safety and Efficacy of Vildagliptin vs. Thiazolidinedione as add-on Therapy to Metformin in Patients With Type 2 Diabetes Not Controlled With Metformin Alone

Completed · Phase 3

Conditions studied: Diabetes Mellitus, Type 2

In brief

This study is designed to evaluate, in a primary care setting, the safety and efficacy of vildaglipgtin as add on therapy to metformin relative to TZD added to metformin in patients with type 2 diabetes inadequately controlled by metformin alone.

Key facts

Study ID

NCT00396227

Run by

Novartis Pharmaceuticals

People needed

2665

Starts

2006-10-01

Last updated by the study team

2016-11-18

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients who have received a stable dose of metformin consisting of at least 1,000 mg/day for four weeks prior to Visit 1 (week-2)
• Agreement to maintain the same dose of metformin from screening to the end of the study
• Age in the range of 18-80 years
• Body mass index (BMI) in the range of 22-40 kg/m2
• HbA1c in the range of 7.0 to 10%
• FPG <270 mg/dL (15 mmol/L)

You may not qualify if…

• A history of type 1 diabetes
• Liver disease
• Treatment with insulin or any oral anti-diabetic other than metformin, within 8 weeks prior to Visit 1
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Novartis Pharmaceuticals — East Hanover, New Jersey, United States

Full record on ClinicalTrials.gov

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