Back to resultsEfficacy and Safety of Vildagliptin in Subjects With Impaired Glucose Tolerance
Primary Purpose
Prediabetic State
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 Prediabetic State focused on measuring Pre-diabetes, vildagliptin, IGT
Eligibility Criteria
Inclusion Criteria: Blood glucose criteria must be met Body mass index (BMI) in the range 23-45 Exclusion Criteria: Diagnosis of diabetes Serious cardiovascular events within the past 6 months Use of insulin or any oral antidiabetic agent Other protocol-defined exclusion criteria may apply
Sites / Locations
- Novartis Pharmaceuticals
Outcomes
Primary Outcome Measures
Change in area under the 0-2 hour prandial glucose curve at 12 weeks
Secondary Outcome Measures
Adverse event profile after 12 weeks of treatment
Change in ratio for postprandial insulin AUC and postprandial glucose AUC (0-2 hours) after 12 weeks of treatment
Change in HOMA B at 12 weeks
Change in fasting insulin at 12 weeks
Change in fasting proinsulin/insulin ratio at 12 weeks
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00237250
Brief Title
Efficacy and Safety of Vildagliptin in Subjects With Impaired Glucose Tolerance
Official Title
Efficacy and Safety of Vildagliptin in Subjects With Impaired Glucose Tolerance
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
July 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to placebo in lowering post-meal blood glucose levels in people with pre-diabetes who have high blood sugar levels after meals.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prediabetic State
Keywords
Pre-diabetes, vildagliptin, IGT
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
171 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
vildagliptin
Primary Outcome Measure Information:
Title
Change in area under the 0-2 hour prandial glucose curve at 12 weeks
Secondary Outcome Measure Information:
Title
Adverse event profile after 12 weeks of treatment
Title
Change in ratio for postprandial insulin AUC and postprandial glucose AUC (0-2 hours) after 12 weeks of treatment
Title
Change in HOMA B at 12 weeks
Title
Change in fasting insulin at 12 weeks
Title
Change in fasting proinsulin/insulin ratio at 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Eligibility Criteria
Inclusion Criteria:
Blood glucose criteria must be met
Body mass index (BMI) in the range 23-45
Exclusion Criteria:
Diagnosis of diabetes
Serious cardiovascular events within the past 6 months
Use of insulin or any oral antidiabetic agent
Other protocol-defined exclusion criteria may apply
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
Novartis Pharmaceuticals
City
East Hanover
State/Province
New Jersey
ZIP/Postal Code
07936
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
17947341
Citation
Rosenstock J, Foley JE, Rendell M, Landin-Olsson M, Holst JJ, Deacon CF, Rochotte E, Baron MA. Effects of the dipeptidyl peptidase-IV inhibitor vildagliptin on incretin hormones, islet function, and postprandial glycemia in subjects with impaired glucose tolerance. Diabetes Care. 2008 Jan;31(1):30-5. doi: 10.2337/dc07-1616. Epub 2007 Oct 18.
Results Reference
derived
Learn more about this trial
Efficacy and Safety of Vildagliptin in Subjects With Impaired Glucose Tolerance
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