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

Purpose

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.

Condition	Intervention	Phase
The Methodology Assessment of Glucose Dependent Insulin Secretion.	Drug: Comparator: exenatide Drug: Comparator: Placebo	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Diagnostic
Official Title:	A Randomized Clinical Trial to Study Glucose Dependent Insulin Secretion Methodologies in Healthy Lean Male Subjects

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Medicines

Drug Information available for: Exenatide

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Change From Baseline in Insulin Concentration [ Time Frame: Pre and Post glucose infusion ] [ Designated as safety issue: No ]

Enrollment:	27
Study Start Date:	September 2008
Study Completion Date:	March 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 exenatide 5mcg	Drug: Comparator: exenatide 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 Name: Byetta
Active Comparator: 2 exenatide 1.5mcg	Drug: Comparator: exenatide 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. Other Name: Byetta
Placebo Comparator: 3 Placebo	Drug: Comparator: Placebo 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

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00782418

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck
ClinicalTrials.gov Identifier:	NCT00782418 History of Changes
Other Study ID Numbers:	2008_568, 104
Study First Received:	October 29, 2008
Results First Received:	March 19, 2010
Last Updated:	April 8, 2013
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products

Additional relevant MeSH terms:

Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013