Completed

NCT Number: NCT00782418

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

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.

Completed

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Key information

Conditions

The Methodology Assessment of Glucose Dependent Insulin Secretion

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comparator: exenatide

Drug

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.

Other names: Byetta

Comparator: placebo

Drug

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.

Primary outcomes

Change From Baseline in Insulin Secretion Rate (ISR) Normalized to Ambient Plasma Glucose

Time frame: 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 C-peptide Concentration

Time frame: Pre and Post glucose infusion
Change From Baseline in Insulin Concentration

Time frame: Pre and Post glucose infusion

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Oct 31, 2008
Registry last updated: Dec 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.