A Study to Assess the Effects of Exenatide on Insulin Secretion Rates Using a Graded Infusion of Intravenous Glucose (0000-099)(COMPLETED)
Phase 1
Completed
- Conditions
- Healthy
- Registration Number
- NCT01021527
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
A four-period study to evaluate if the grade glucose infusion procedure will be able to detect an increase in beta-cell glucose sensitivity from exenatide compared to no treatment in healthy subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 12
Inclusion Criteria
- Subject is in good health
- Subject is a non-smoker
Exclusion Criteria
- Subject has irritable bowel disease
- Subject has a history of cancer
- Subject has a history of hypertension requiring treatment
- Subject is unable to refrain from the use of any prescription or non-prescription medication
- Subject consumes excessive amounts of alcohol or caffeine
- Subject has had major surgery, donated blood or participated in another investigational study in the past 4 weeks
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method beta-cell glucose sensitivity (slope of the relationship between insulin secretion rate and glucose) 0-160 minutes after start of infusion
- Secondary Outcome Measures
Name Time Method safety and tolerability of a graded glucose infusion procedure measured by the number of clinical adverse experiences 11 weeks