Efficacy and Safety of Vildagliptin in Subjects With Impaired Glucose Tolerance
Phase 3
Completed
- Conditions
- Prediabetic State
- Registration Number
- NCT00237250
- Lead Sponsor
- Novartis
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 171
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in area under the 0-2 hour prandial glucose curve at 12 weeks
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Novartis Pharmaceuticals
🇺🇸East Hanover, New Jersey, United States