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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: The Methodology Assessment of Glucose Dependent Insulin Secretion

Treatments: Drug: Comparator: exenatide; Drug: Comparator: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00782418

2008_568

0000-104

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

27 participants in 3 patient groups, including a placebo group

1

Active Comparator group

Description:

exenatide 5mcg

Treatment:

Drug: Comparator: exenatide

Drug: Comparator: exenatide

2

Active Comparator group

Description:

exenatide 1.5mcg

Treatment:

Drug: Comparator: exenatide

Drug: Comparator: exenatide

3

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Comparator: Placebo