- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00351546
A Study to Assess the Effects of DPP-4 Inhibition on Insulin Sensitivity in Type 2 Diabetes
May 4, 2012 updated by: Novartis
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Effect on insulin sensitivity at 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
---|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David Kelley, MD, University of Pittsburgh
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2005
Primary Completion (Actual)
November 1, 2005
Study Completion (Actual)
December 1, 2005
Study Registration Dates
First Submitted
July 11, 2006
First Submitted That Met QC Criteria
July 11, 2006
First Posted (Estimate)
July 13, 2006
Study Record Updates
Last Update Posted (Estimate)
May 7, 2012
Last Update Submitted That Met QC Criteria
May 4, 2012
Last Verified
May 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Immune System Diseases
- Endocrine System Diseases
- Hyperinsulinism
- Hypersensitivity
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Insulin Resistance
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Protease Inhibitors
- Dipeptidyl-Peptidase IV Inhibitors
- Vildagliptin
Other Study ID Numbers
- CLAF237A2352
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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