To Compare the Efficacy and Safey of Vildagliptin Compared to Voglibose in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00368134
First received: August 23, 2006
Last updated: June 27, 2007
Last verified: June 2007

August 23, 2006
June 27, 2007
August 2006
Not Provided
Change in HbA1c after 12 weeks
Same as current
Complete list of historical versions of study NCT00368134 on ClinicalTrials.gov Archive Site
  • Change in FPG after 12 weeks
  • Change in Fasting Lipids after 12 weeks
  • Change in HOMA-IR after 12 weeks
  • Change in HOMA-B after 12 weeks
  • Safety Profile after 12 weeks treatment
Same as current
Not Provided
Not Provided
 
To Compare the Efficacy and Safey of Vildagliptin Compared to Voglibose in Patients With Type 2 Diabetes
A Multicenter, Randomized, Double-Blind, Active-Controlled Study to Compare the Effects of 12 Weeks Treatment With Vildagliptin 50 mg Bid to Voglibose 0.2 mg Tid in Patients With Type 2 Diabetes

This study is designed to evaluate the efficacy, safety and tolerability of vildagliptin compared to voglibose in patients with type 2 diabetes. Please note this study is not being conducted in the United States.

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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
370
Not Provided
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Inclusion Criteria:

  • Diagnosis as Type 2 Diabetes
  • Patients who have been placed on dietary therapy/exercise therapy, without achievement of glycemic control
  • Outpatients

Exclusion Criteria:

  • Type 1 diabetes mellitus, diabetes that is a result of pancreatic injury, or secondary forms of diabetes
  • Significant heart diseases
  • Significant diabetic complications

Other protocol-defined inclusion/exclusion criteria may apply

Both
20 Years and older
Not Provided
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00368134
CLAF237A1301
Not Provided
Not Provided
Novartis
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
June 2007

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