Extension to a Study on the Efficacy and Safety of Vildagliptin in Combination With Metformin in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00138515
First received: August 27, 2005
Last updated: May 1, 2012
Last verified: May 2012

August 27, 2005
May 1, 2012
November 2004
May 2006   (final data collection date for primary outcome measure)
  • Safety of vildagliptin in combination with metformin during 52 weeks of treatment
  • Change from baseline in HbA1c at 52 weeks
Not Provided
Complete list of historical versions of study NCT00138515 on ClinicalTrials.gov Archive Site
  • Change in HbA1c between 24 weeks and 52 weeks
  • Change from baseline in fasting plasma glucose at 52 weeks
  • Change in fasting plasma glucose between 24 weeks and 52 weeks
  • Change from baseline in HOMA B at 52 weeks
  • Change from baseline in HOMA IR at 52 weeks
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Extension to a Study on the Efficacy and Safety of Vildagliptin in Combination With Metformin in Patients With Type 2 Diabetes
Extension to a Study on the Efficacy and Safety of Vildagliptin in Combination With Metformin in Patients With Type 2 Diabetes

Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. This is a 28-week extension to a study to assess the safety and effectiveness of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to metformin in people with type 2 diabetes who are not at target blood glucose levels on metformin alone. The purpose of the extension study is to gather data on the long-term safety and effectiveness of vildagliptin in people with type 2 diabetes.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
Drug: vildagliptin
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
418
May 2006
May 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Only patients successfully completing study CLAF237A2303 are eligible
  • Written informed consent
  • Ability to comply with all study requirements

Exclusion Criteria:

  • Premature discontinuation from CLAF237A2303
  • Other protocol-defined exclusion criteria may apply
Both
18 Years to 78 Years
Not Provided
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00138515
CLAF237A2303E1
Not Provided
Novartis
Novartis
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
May 2012

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