A Study to Assess the Effects of Exenatide on Insulin Secretion Rates Using a Graded Infusion of Intravenous Glucose (0000-099)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01021527
First received: November 25, 2009
Last updated: May 8, 2014
Last verified: May 2014
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01021527     History of Changes
Other Study ID Numbers: 0000-099, 099, 2009_697
Study First Received: November 25, 2009
Last Updated: May 8, 2014
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

Additional relevant MeSH terms:
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 18, 2014