Back to resultsA Study to Evaluate the Effects of Vildagliptin on the Insulin Response to Glucose in Subjects With Pre-diabetes
Primary Purpose
Pre-diabetes
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Vildagliptin
Sponsored by
About this trial
This is an interventional treatment trial for Pre-diabetes focused on measuring Vildaglptin, Pre-diabetes
Eligibility Criteria
Inclusion Criteria: BMI in the range 22-45 and with a stable weight for the last 6 months Blood glucose criteria must be met Written informed consent Exclusion Criteria: Pregnancy or lactation Previous diagnosis of type 2 diabetes or treatment with hypoglycemic agents Type 1 diabetes Evidence of cardiovascular complications as defined by the protocol Evidence of diabetic complications as defined by the protocol
Sites / Locations
- University of Washington
Outcomes
Primary Outcome Measures
Change from baseline in acute insulin response to an iv glucose load at 6 weeks
Secondary Outcome Measures
Change from baseline in glucose disappearance rate at 6 weeks
Change from baseline in glucose disappearance rate at 8 weeks
Change from baseline in insulin sensitivity at 6 weeks
Change from baseline in insulin sensitivity at 8 weeks
Change from baseline in acute insulin response to an iv glucose load at 8 weeks
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00312130
Brief Title
A Study to Evaluate the Effects of Vildagliptin on the Insulin Response to Glucose in Subjects With Pre-diabetes
Official Title
A Single-blind, Single-treatment Study to Evaluate the Effects of Vildagliptin on Response to an Intravenous Glucose Load in Pre-diabetic Subjects With Impaired Fasting Glucose
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief Summary
This is an exploratory study to assess whether vildagliptin, an unapproved drug, can increase insulin secretion in subjects with pre-diabetes who have a defect in the insulin response and elevated levels of fasting glucose.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-diabetes
Keywords
Vildaglptin, Pre-diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Non-Randomized
Enrollment
20 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Vildagliptin
Primary Outcome Measure Information:
Title
Change from baseline in acute insulin response to an iv glucose load at 6 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in glucose disappearance rate at 6 weeks
Title
Change from baseline in glucose disappearance rate at 8 weeks
Title
Change from baseline in insulin sensitivity at 6 weeks
Title
Change from baseline in insulin sensitivity at 8 weeks
Title
Change from baseline in acute insulin response to an iv glucose load at 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
BMI in the range 22-45 and with a stable weight for the last 6 months
Blood glucose criteria must be met
Written informed consent
Exclusion Criteria:
Pregnancy or lactation
Previous diagnosis of type 2 diabetes or treatment with hypoglycemic agents
Type 1 diabetes
Evidence of cardiovascular complications as defined by the protocol
Evidence of diabetic complications as defined by the protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17909087
Citation
Utzschneider KM, Tong J, Montgomery B, Udayasankar J, Gerchman F, Marcovina SM, Watson CE, Ligueros-Saylan MA, Foley JE, Holst JJ, Deacon CF, Kahn SE. The dipeptidyl peptidase-4 inhibitor vildagliptin improves beta-cell function and insulin sensitivity in subjects with impaired fasting glucose. Diabetes Care. 2008 Jan;31(1):108-13. doi: 10.2337/dc07-1441. Epub 2007 Oct 1.
Results Reference
result
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A Study to Evaluate the Effects of Vildagliptin on the Insulin Response to Glucose in Subjects With Pre-diabetes
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