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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%)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00728351
First received: July 31, 2008
Last updated: January 2, 2013
Last verified: January 2013

July 31, 2008
January 2, 2013
June 2008
February 2010   (final data collection date for primary outcome measure)
HbA1c reduction after 24 weeks of treatment in patients with T2DM inadequately controlled with metformin monotherapy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
HbA1c reduction after 24 weeks of treatment in patients with T2DM inadequately controlled with metformin monotherapy
Complete list of historical versions of study NCT00728351 on ClinicalTrials.gov Archive Site
  • FPG reduction [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Body weight change from baseline [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Changes in the fasting lipid profile [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • FPG reduction
  • Safety and tolerability
  • Body weight change from baseline
  • Changes in the fasting lipid profile
Not Provided
Not Provided
 
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%)
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: vildagliptin + metformin
  • Drug: metformin
    1000 bid metformin
  • Experimental: vildagliptin + metformin
    Intervention: Drug: vildagliptin + metformin
  • Active Comparator: metformin
    Intervention: Drug: metformin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
317
Not Provided
February 2010   (final data collection date for primary outcome measure)

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

Both
18 Years to 78 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   France,   Germany,   Hungary,   Poland
 
NCT00728351
CLMF237A2309
Yes
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP