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OpenTrials
Completed

NCT Number: NCT00728351

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%)

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–78 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cabinet d'Endocrinologie-Maladies Métaboliques, Annecy, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • History of T2DM treated with Metformin

Exclusion criteria

  • FPG >= 260 mg/dL (14.4mmol/L)

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

vildagliptin + metformin

Drug

metformin

Drug

1000 bid metformin

Primary outcomes

  1. HbA1c reduction after 24 weeks of treatment in patients with T2DM inadequately controlled with metformin monotherapy

    Time frame: 24 weeks

Secondary outcomes

  1. FPG reduction

    Time frame: 24 weeks

  2. Safety and tolerability

    Time frame: 24 weeks

  3. Body weight change from baseline

    Time frame: 24 weeks

  4. Changes in the fasting lipid profile

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Multicenter, Double-blind, Randomized Study to Compare the Efficacy of 24 Weeks Treatment With Fixed Combination Therapy of Vildagliptin and Metformin (25/1000 mg Bid) Versus Metformin Monotherapy (1000 mg Bid) in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy.

Important dates

Study start
2008
Primary completion
2010
First posted
Aug 5, 2008
Registry last updated
Dec 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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