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
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Vildagliptin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Study to Assess the Effects of DPP-4 Inhibition on Insulin Sensitivity in Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Effect on insulin sensitivity at 6 weeks

Secondary Outcome Measures:
  • 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

Enrollment: 12
Study Start Date: February 2005
Study Completion Date: December 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00351546

Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: David Kelley, MD University of Pittsburgh
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00351546     History of Changes
Other Study ID Numbers: CLAF237A2352
Study First Received: July 11, 2006
Last Updated: May 4, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Vildagliptin
Type 2 diabetes
Insulin sensitivity
Insulin action

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism
Vildagliptin
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2014