Efficacy of Fixed Combination Therapy of Vildagliptin and Metformin Compared to the Individual Monotherapy Components in Drug Naive Patients With Type 2 Diabetes

Completed · Phase 3

Conditions studied: Diabetes Mellitus, Type 2

In brief

The purpose of this study is to evaluate the efficacy and safety of a fixed combination of vildagliptin and metformin in lowering blood glucose in patients with type 2 diabetes

Key facts

Study ID

NCT00382096

Run by

Novartis Pharmaceuticals

People needed

1179

Starts

2006-09-01

Expected to finish

2008-06-03

Last updated by the study team

2020-12-19

Who can join

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

You may qualify if…

• Male or female (non-fertile or of childbearing potential using a medically approved birth control method) patients with type 2 diabetes
• Diagnosis of T2DM for at least 4 weeks prior to study entry
• Age 18 - 78 years inclusive
• Body mass index (BMI) of 22 - 40 kg/m2
• HbA1c: 7.5 - 11% inclusive
• FPG <270 mg/dL (15 mmol/L)

You may not qualify if…

• Pregnant or lactating female
• A history of type 1 diabetes
• Evidence of significant diabetic complications
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Novartis Pharmaceuticals — East Hanover, New Jersey, United States
• Study site — Multiple Locations, Germany

Full record on ClinicalTrials.gov

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