Back to resultsA Study to Assess the Effects of DPP-4 Inhibition on Insulin Sensitivity in Type 2 Diabetes
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Vildagliptin
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Vildagliptin, Type 2 diabetes, Insulin sensitivity, Insulin action
Eligibility 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
Sites / Locations
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00351546
Brief Title
A Study to Assess the Effects of DPP-4 Inhibition on Insulin Sensitivity in Type 2 Diabetes
Official Title
A Study to Assess the Effects of DPP-4 Inhibition on Insulin Sensitivity in Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
November 2005 (Actual)
Study Completion Date
December 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Vildagliptin, Type 2 diabetes, Insulin sensitivity, Insulin action
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Vildagliptin
Primary Outcome Measure Information:
Title
Effect on insulin sensitivity at 6 weeks
Secondary Outcome Measure Information:
Title
Lipolysis rate after 6 weeks of treatment
Title
Plasma free fatty acid concentration after 6 weeks of treatment
Title
Hepatic glucose production after 6 weeks of treatment
Title
Glucose disposal after 6 weeks of treatment
Title
Gluconeogenesis rate after 6 weeks of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Kelley, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
A Study to Assess the Effects of DPP-4 Inhibition on Insulin Sensitivity in Type 2 Diabetes
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