Efficacy and Safety of Fixed Combination Therapy of Vildagliptin and Metformin (25/1000 mg Bid) in Patients With Type 2 Diabetes Inadequately Controlled With Prior Metformin Monotherapy (HbA1c 7.0-9.5%)

Completed · Phase 3

Conditions studied: Diabetes Mellitus, Type 2

In brief

The present study is designed to evaluate the efficacy and safety of fixed combination therapy of vildagliptin and metformin (25/1000 mg bid) in patients with type 2 diabetes inadequately controlled with prior metformin monotherapy.

Key facts

Study ID

NCT00728351

Run by

Novartis Pharmaceuticals

People needed

317

Starts

2008-06-01

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…

• History of T2DM treated with Metformin

You may not qualify if…

• FPG >= 260 mg/dL (14.4mmol/L)
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Study site — Long Beach, California, United States
• Study site — Denver, Colorado, United States
• Study site — Bangor, Maine, United States
• Study site — Billings, Montana, United States
• Novartis Investigative Site — New Brunswick, New Jersey, United States
• Study site — Trenton, New Jersey, United States
• Study site — Wilmington, North Carolina, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Uniontown, Pennsylvania, United States
• Study site — Taylors, South Carolina, United States
• Study site — Houston, Texas, United States
• Study site — Houston, Texas, United States
• Study site — Houston, Texas, United States
• Study site — Norfolk, Virginia, United States
• Study site — Wenatchee, Washington, United States
• Cabinet d'Endocrinologie-Maladies Métaboliques — Annecy, France
• Service Endocrinologic & Metabolisme — Paris, France
• Polycliniques des minguettes — Vénissieux, France
• Hausärztliche Praxis — Aschaffenburg, Germany
• Klinische Forschung Berlin Mitte GmbH — Berlin, Germany
• AVK — Berlin, Germany
• Gemeinschaftspraxis — Celle, Germany
• Malteser KM — Duisburg, Germany
• Untertrintroper Hausarztzentrum — Essen, Germany
• Study site — Pine Bluff, Arkansas, United States

Full record on ClinicalTrials.gov

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