A Randomized Clinical Trial to Study Glucose Dependent Insulin Secretion Methodologies in Healthy Lean Male Subjects
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- The Methodology Assessment of Glucose Dependent Insulin Secretion
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 27
- Primary Endpoint
- Change From Baseline in Insulin Secretion Rate (ISR) Normalized to Ambient Plasma Glucose
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
This study will compare graded glucose infusion (GGI) to the hyperglycemic clamp (HGC) for assessment of glucose-dependent insulin secretion (GDIS) using exenatide as a probe.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject has a Body Mass Index (BMI) of less than or equal to 26 kg/m2 at screening
- •Subject is judged to be in good health
- •Subject has been a nonsmoker for at least 3 months
- •Subject is willing to avoid strenuous physical activity for the duration of the study
Exclusion Criteria
- •Subject has a history of high blood pressure requiring treatment
- •Subject has a history of diabetes or a family history of diabetes mellitus
- •Subject is unable to discontinue all prescription and non-prescription drugs for duration of study
- •Subject consumes more than 3 alcoholic beverages per day
- •Subject consumes more than 6 servings of caffeinated beverages per day (1 serving = 120mg caffeine)
- •Subject has had major surgery or has donated or loss 1 unit of blood within 4 weeks of screening
- •Subject has multiple and/or severe allergies to foods or drugs
- •Subject is a regular user of illegal drugs
- •Subject is unwilling or unable to consume the standardized meals during the study and/or is on a carbohydrate restricted diet
Outcomes
Primary Outcomes
Change From Baseline in Insulin Secretion Rate (ISR) Normalized to Ambient Plasma Glucose
Time Frame: Steady-state of HGC: 90 - 120 minutes post dose; highest glucose infusion rate of GGI: 120 - 160 minutes post dose
Comparison of Glucose Dependent Insulin Secretion (GDIS) measured after HGC at steady-state to GDIS measured after GGI at the highest glucose infusion rate. Insulin Secretion Rate (ISR)/ Blood Glucose (BG)
Change From Baseline in Insulin Concentration
Time Frame: Pre and Post glucose infusion
Change From Baseline in C-peptide Concentration
Time Frame: Pre and Post glucose infusion