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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00368134
Recruitment Status : Completed
First Posted : August 24, 2006
Last Update Posted : June 28, 2007
Information provided by:

August 23, 2006
August 24, 2006
June 28, 2007
August 2006
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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
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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.
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Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
Drug: Vildagliptin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
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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

Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
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Contact information is only displayed when the study is recruiting subjects
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
June 2007

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