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

A Randomized Clinical Trial to Study Glucose Dependent Insulin Secretion Methodologies in Healthy Lean Male Subjects

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.

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