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%)

Verified by: Novartis, March 2011
First Received: July 31, 2008 | Last Updated: March 1, 2011 | Phase: Phase 3 | Start Date: June 2008
Overall Status: Completed | Estimated Enrollment: 317
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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...

Brief Summary

Official 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.”

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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
  • Study Primary Completion Date: February 2010

Intervention(s) in this Clinical Trial

  • Drug: vildagliptin + metformin
  • Drug: metformin
    • 1000 bid metformin

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: vildagliptin + metformin
  • Active Comparator: metformin

Outcome Measures for this Clinical Trial

Primary Measures

  • HbA1c reduction after 24 weeks of treatment in patients with T2DM inadequately controlled with metformin monotherapy
    • Time Frame: 24 weeks
      Safety Issue?: No

Secondary Measures

  • FPG reduction
    • Time Frame: 24 weeks
      Safety Issue?: No
  • Safety and tolerability
    • Time Frame: 24 weeks
      Safety Issue?: No
  • Body weight change from baseline
    • Time Frame: 24 weeks
      Safety Issue?: No
  • Changes in the fasting lipid profile
    • Time Frame: 24 weeks
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 78 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Novartis Pharmaceuticals Industry

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceuticals Study Director Novartis Pharmaceuticals  

Additional Information

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00728351

Study ID Number: CLMF237A2309

ClinicalTrials.gov Identifier: NCT00728351

Health Authority: France: Afssaps - French Health Products Safety Agency

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