A Study to Assess the Effects of Exenatide on Insulin Secretion Rates Using a Graded Infusion of Intravenous Glucose - Full Text View

Purpose

A four-period study to evaluate if the grade glucose infusion procedure will be able to detect an increase in beta-cell glucose sensitivity from exenatide compared to no treatment in healthy subjects.

Condition	Intervention	Phase
Healthy	Other: Comparator: Treatment A Drug: Comparator: Treatment B Drug: Comparator: Treatment C Procedure: Comparator: graded glucose infusion	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	A Randomized, 4-Period Study to Assess the Effects of Exenatide on Insulin Secretion Rates Using a Graded Infusion of Intravenous Glucose

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Medicines

Drug Information available for: Dextrose Exenatide

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

beta-cell glucose sensitivity (slope of the relationship between insulin secretion rate and glucose) [ Time Frame: 0-160 minutes after start of infusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

safety and tolerability of a graded glucose infusion procedure measured by the number of clinical adverse experiences [ Time Frame: 11 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	12
Study Start Date:	February 2008
Study Completion Date:	April 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Treatment Sequence 1 A-B-C-C	Other: Comparator: Treatment A No Treatment Drug: Comparator: Treatment B single dose administration of exenatide 5ug by subcutaneous injection Drug: Comparator: Treatment C single dose administration of exenatide 10ug by subcutaneous injection Procedure: Comparator: graded glucose infusion A stepwise graded infusion of glucose (20% dextrose [D20]) with a stable rate of infusion maintained for 40 minutes for each of 5 steps, with steps at 2,4,6,8 and 12 mg/kg/min. Infusion will be performed during each of the 4 treatment periods.
Experimental: Treatment Sequence 2 B-C-A-C	Other: Comparator: Treatment A No Treatment Drug: Comparator: Treatment B single dose administration of exenatide 5ug by subcutaneous injection Drug: Comparator: Treatment C single dose administration of exenatide 10ug by subcutaneous injection Procedure: Comparator: graded glucose infusion A stepwise graded infusion of glucose (20% dextrose [D20]) with a stable rate of infusion maintained for 40 minutes for each of 5 steps, with steps at 2,4,6,8 and 12 mg/kg/min. Infusion will be performed during each of the 4 treatment periods.
Experimental: Treatment Sequence 3 C-A-B-C	Other: Comparator: Treatment A No Treatment Drug: Comparator: Treatment B single dose administration of exenatide 5ug by subcutaneous injection Drug: Comparator: Treatment C single dose administration of exenatide 10ug by subcutaneous injection Procedure: Comparator: graded glucose infusion A stepwise graded infusion of glucose (20% dextrose [D20]) with a stable rate of infusion maintained for 40 minutes for each of 5 steps, with steps at 2,4,6,8 and 12 mg/kg/min. Infusion will be performed during each of the 4 treatment periods.
Experimental: Treatment Sequence 4 A-C-B-C	Other: Comparator: Treatment A No Treatment Drug: Comparator: Treatment B single dose administration of exenatide 5ug by subcutaneous injection Drug: Comparator: Treatment C single dose administration of exenatide 10ug by subcutaneous injection Procedure: Comparator: graded glucose infusion A stepwise graded infusion of glucose (20% dextrose [D20]) with a stable rate of infusion maintained for 40 minutes for each of 5 steps, with steps at 2,4,6,8 and 12 mg/kg/min. Infusion will be performed during each of the 4 treatment periods.
Experimental: Treatment Sequence 5 B-A-C-C	Other: Comparator: Treatment A No Treatment Drug: Comparator: Treatment B single dose administration of exenatide 5ug by subcutaneous injection Drug: Comparator: Treatment C single dose administration of exenatide 10ug by subcutaneous injection Procedure: Comparator: graded glucose infusion A stepwise graded infusion of glucose (20% dextrose [D20]) with a stable rate of infusion maintained for 40 minutes for each of 5 steps, with steps at 2,4,6,8 and 12 mg/kg/min. Infusion will be performed during each of the 4 treatment periods.
Experimental: Treatment Sequence 6 C-B-A-C	Other: Comparator: Treatment A No Treatment Drug: Comparator: Treatment B single dose administration of exenatide 5ug by subcutaneous injection Drug: Comparator: Treatment C single dose administration of exenatide 10ug by subcutaneous injection Procedure: Comparator: graded glucose infusion A stepwise graded infusion of glucose (20% dextrose [D20]) with a stable rate of infusion maintained for 40 minutes for each of 5 steps, with steps at 2,4,6,8 and 12 mg/kg/min. Infusion will be performed during each of the 4 treatment periods.

Eligibility

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

Criteria

Inclusion Criteria:

Subject is in good health
Subject is a non-smoker

Exclusion Criteria:

Subject has irritable bowel disease
Subject has a history of cancer
Subject has a history of hypertension requiring treatment
Subject is unable to refrain from the use of any prescription or non-prescription medication
Subject consumes excessive amounts of alcohol or caffeine
Subject has had major surgery, donated blood or participated in another investigational study in the past 4 weeks

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01021527

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier:	NCT01021527 History of Changes
Other Study ID Numbers:	2009_697, 099
Study First Received:	November 25, 2009
Last Updated:	November 25, 2009
Health Authority:	Belgium: Directorate general for the protection of Public health: Medicines

Additional relevant MeSH terms:

Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013