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

Phase 1

Completed

• Conditions: The Methodology Assessment of Glucose Dependent Insulin Secretion

• Registration Number: NCT00782418
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-10-29
• Study First Submitted QC: 2008-10-29
• Study First Posted: 2008-10-31
• Primary Completion: 2009-02
• Study Completion: 2009-03
• Results First Submitted: 2010-03-19
• Results First Submitted QC: 2010-03-19
• Results First Posted: 2010-04-06
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-03
• Last Update Posted: 2016-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 27

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Insulin Secretion Rate (ISR) Normalized to Ambient Plasma Glucose	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	Pre and Post glucose infusion
Change From Baseline in C-peptide Concentration	Pre and Post glucose infusion