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%)

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: vildagliptin + metformin; Drug: metformin

• Registration Number: NCT00728351
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-07-31
• Study First Submitted QC: 2008-08-04
• Study First Posted: 2008-08-05
• Primary Completion: 2010-02
• Status Verified: 2013-01
• Disposition First Submitted: 2013-01-02
• Disposition First Submitted QC: 2013-01-02
• Disposition First Posted: 2013-01-04
• Last Update Submitted: 2020-12-11
• Last Update Posted: 2020-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 317

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vildagliptin + metformin	vildagliptin + metformin	-
metformin	metformin	-

Primary Outcome Measures

Name	Time	Method
HbA1c reduction after 24 weeks of treatment in patients with T2DM inadequately controlled with metformin monotherapy	24 weeks

Secondary Outcome Measures

Name	Time	Method
Body weight change from baseline	24 weeks
Safety and tolerability	24 weeks
FPG reduction	24 weeks
Changes in the fasting lipid profile	24 weeks

Trial Locations

Locations (45)

Novartis Investigative Site; 🇺🇸 New Brunswick, New Jersey, United States

Cabinet d'Endocrinologie-Maladies Métaboliques; 🇫🇷 Annecy, France

Service Endocrinologic & Metabolisme; 🇫🇷 Paris, France

Polycliniques des minguettes; 🇫🇷 Venissieux, 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

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