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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Merck

ClinicalTrials.gov Identifier:

NCT00782418

First received: October 29, 2008

Last updated: April 8, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

October 29, 2008

Last Updated Date

April 8, 2013

Start Date ^ICMJE

September 2008

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Comparison of GDIS measured after HGC at steady state to GDIS measured after GGI at the highest glucose infusion rate [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00782418 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Changes in C-peptide and plasma insulin concentrations measured by HGC [ Time Frame: Pre and Post glucose infusion ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic

Condition ^ICMJE

The Methodology Assessment of Glucose Dependent Insulin Secretion.

Intervention ^ICMJE

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
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
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.

Study Arm (s)

Active Comparator: 1
exenatide 5mcg

Intervention: Drug: Comparator: exenatide
Active Comparator: 2
exenatide 1.5mcg

Intervention: Drug: Comparator: exenatide
Placebo Comparator: 3
Placebo

Intervention: Drug: Comparator: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2009

Primary Completion Date

February 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00782418

Other Study ID Numbers ^ICMJE

2008_568, 104

Has Data Monitoring Committee

Not Provided

Responsible Party

Merck

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

April 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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