A Study to Assess the Effects of Exenatide on Insulin Secretion Rates Using a Graded Infusion of Intravenous Glucose (0000-099)(COMPLETED)
NCT ID: NCT01021527
Last Updated: 2015-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
12 participants
INTERVENTIONAL
2008-02-29
2008-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Treatment Sequence 1
A-B-C-C
Comparator: Treatment A
No Treatment
Comparator: Treatment B
single dose administration of exenatide 5ug by subcutaneous injection
Comparator: Treatment C
single dose administration of exenatide 10ug by subcutaneous injection
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.
Treatment Sequence 2
B-C-A-C
Comparator: Treatment A
No Treatment
Comparator: Treatment B
single dose administration of exenatide 5ug by subcutaneous injection
Comparator: Treatment C
single dose administration of exenatide 10ug by subcutaneous injection
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.
Treatment Sequence 3
C-A-B-C
Comparator: Treatment A
No Treatment
Comparator: Treatment B
single dose administration of exenatide 5ug by subcutaneous injection
Comparator: Treatment C
single dose administration of exenatide 10ug by subcutaneous injection
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.
Treatment Sequence 4
A-C-B-C
Comparator: Treatment A
No Treatment
Comparator: Treatment B
single dose administration of exenatide 5ug by subcutaneous injection
Comparator: Treatment C
single dose administration of exenatide 10ug by subcutaneous injection
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.
Treatment Sequence 5
B-A-C-C
Comparator: Treatment A
No Treatment
Comparator: Treatment B
single dose administration of exenatide 5ug by subcutaneous injection
Comparator: Treatment C
single dose administration of exenatide 10ug by subcutaneous injection
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.
Treatment Sequence 6
C-B-A-C
Comparator: Treatment A
No Treatment
Comparator: Treatment B
single dose administration of exenatide 5ug by subcutaneous injection
Comparator: Treatment C
single dose administration of exenatide 10ug by subcutaneous injection
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.
Interventions
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Comparator: Treatment A
No Treatment
Comparator: Treatment B
single dose administration of exenatide 5ug by subcutaneous injection
Comparator: Treatment C
single dose administration of exenatide 10ug by subcutaneous injection
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 Criteria
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Inclusion Criteria
* Subject is a non-smoker
Exclusion Criteria
* 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
18 Years
45 Years
MALE
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Other Identifiers
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0000-099
Identifier Type: -
Identifier Source: org_study_id
099
Identifier Type: -
Identifier Source: secondary_id
2009_697
Identifier Type: -
Identifier Source: secondary_id
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