A Study to Assess the Effects of DPP-4 Inhibition on Insulin Sensitivity in Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00351546
First received: July 11, 2006
Last updated: May 4, 2012
Last verified: May 2012

July 11, 2006
May 4, 2012
February 2005
November 2005   (final data collection date for primary outcome measure)
Effect on insulin sensitivity at 6 weeks
Same as current
Complete list of historical versions of study NCT00351546 on ClinicalTrials.gov Archive Site
  • Lipolysis rate after 6 weeks of treatment
  • Plasma free fatty acid concentration after 6 weeks of treatment
  • Hepatic glucose production after 6 weeks of treatment
  • Glucose disposal after 6 weeks of treatment
  • Gluconeogenesis rate after 6 weeks of treatment
Same as current
Not Provided
Not Provided
 
A Study to Assess the Effects of DPP-4 Inhibition on Insulin Sensitivity in Type 2 Diabetes
A Study to Assess the Effects of DPP-4 Inhibition on Insulin Sensitivity in Type 2 Diabetes

Type 2 diabetes results when the body does not produce enough insulin and/or is unable to properly use the insulin it makes (insulin resistance). This study was undertaken to assess the effects of vildagliptin on insulin sensitivity in people with type 2 diabetes.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover 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
12
December 2005
November 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosed with type 2 diabetes at least 3 months prior to screening
  • Blood glucose criteria must be met
  • On stable dose of metformin therapy
  • BMI less than or equal to 39

Exclusion Criteria:

  • Type 1 diabetes, diabetes resulting from pancreatic injury or secondary forms of diabetes
  • Treatment with thiazolidinediones or use of insulin within the previous 3 months
  • Significant illness within 2 weeks prior to dosing
  • High fasting triglycerides as defined by the protocol

Other protocol-defined inclusion/exclusion criteria may apply

Both
21 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00351546
CLAF237A2352
Not Provided
Not Provided
Novartis
Not Provided
Principal Investigator: David Kelley, MD University of Pittsburgh
Novartis
May 2012

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