A Study to Compare Methodologies for Assessing Glucose-Dependent Insulin Secretion (0000-104)(COMPLETED)

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Exenatide

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