A Study to Assess the Effects of Exenatide on Insulin Secretion Rates Using a Graded Infusion of Intravenous Glucose (0000-099)(COMPLETED)
April 27, 2015 updated by: Merck Sharp & Dohme LLC
A Randomized, 4-Period Study to Assess the Effects of Exenatide on Insulin Secretion Rates Using a Graded Infusion of Intravenous Glucose
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Treatment Sequence 1
A-B-C-C
|
No Treatment
single dose administration of exenatide 5ug by subcutaneous injection
single dose administration of exenatide 10ug by subcutaneous injection
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
|
No Treatment
single dose administration of exenatide 5ug by subcutaneous injection
single dose administration of exenatide 10ug by subcutaneous injection
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
|
No Treatment
single dose administration of exenatide 5ug by subcutaneous injection
single dose administration of exenatide 10ug by subcutaneous injection
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
|
No Treatment
single dose administration of exenatide 5ug by subcutaneous injection
single dose administration of exenatide 10ug by subcutaneous injection
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
|
No Treatment
single dose administration of exenatide 5ug by subcutaneous injection
single dose administration of exenatide 10ug by subcutaneous injection
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
|
No Treatment
single dose administration of exenatide 5ug by subcutaneous injection
single dose administration of exenatide 10ug by subcutaneous injection
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
beta-cell glucose sensitivity (slope of the relationship between insulin secretion rate and glucose)
Time Frame: 0-160 minutes after start of infusion
|
0-160 minutes after start of infusion
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
safety and tolerability of a graded glucose infusion procedure measured by the number of clinical adverse experiences
Time Frame: 11 weeks
|
11 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2008
Primary Completion (Actual)
March 1, 2008
Study Completion (Actual)
April 1, 2008
Study Registration Dates
First Submitted
November 25, 2009
First Submitted That Met QC Criteria
November 25, 2009
First Posted (Estimate)
November 30, 2009
Study Record Updates
Last Update Posted (Estimate)
April 28, 2015
Last Update Submitted That Met QC Criteria
April 27, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- 0000-099
- 099
- 2009_697
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.