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

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01021527
First received: November 25, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  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:


Further study details as provided by Merck Sharp & Dohme Corp.:

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 Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  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: Federal Agency for Medicines and Health Products, FAMHP

Additional relevant MeSH terms:
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014