Healthy
Conditions
Brief summary
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.
Interventions
OTHERComparator: Treatment A
No Treatment
DRUGComparator: Treatment B
single dose administration of exenatide 5ug by subcutaneous injection
DRUGComparator: Treatment C
single dose administration of exenatide 10ug by subcutaneous injection
PROCEDUREComparator: 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.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| beta-cell glucose sensitivity (slope of the relationship between insulin secretion rate and glucose) | 0-160 minutes after start of infusion |
Secondary
| Measure | Time frame |
|---|---|
| safety and tolerability of a graded glucose infusion procedure measured by the number of clinical adverse experiences | 11 weeks |
Outcome results
None listed