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

Merck Sharp & Dohme LLC27 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

Conditions

The Methodology Assessment of Glucose Dependent Insulin Secretion

Interventions

Comparator: exenatideDRUG

exenatide in two 5mcg subcutaneous doses 120 minutes apart, followed by either HGC or GGI. After a 14 day washout period two additional 5mcg doses will be administered, followed by HCG or GGI.

Comparator: exenatideDRUG

exenatide in two 1.5mcg subcutaneous doses 120 minutes apart, followed by either HGC or GGI. After a 14 day washout period two additional 1.5mcg doses will be administered, followed by HCG or GGI.

Comparator: PlaceboDRUG

5% osmitrol in two 60 mcL subcutaneous doses 120 minutes apart, followed by either HGC or GGI. After a 14 day washout period two additional 60 mcL doses will be administered, followed by HCG or GGI.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

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)

Time frame: Steady-state of HGC: 90 - 120 minutes post dose; highest glucose infusion rate of GGI: 120 - 160 minutes post dose

Change From Baseline in C-peptide Concentration

Time frame: Pre and Post glucose infusion

Change From Baseline in Insulin Concentration

Time frame: Pre and Post glucose infusion

Data from ClinicalTrials.gov

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