Status:
COMPLETED
A Study to Compare Methodologies for Assessing Glucose-Dependent Insulin Secretion (0000-104)(COMPLETED)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
The Methodology Assessment of Glucose Dependent Insulin Secretion
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
This study will compare graded glucose infusion (GGI) to the hyperglycemic clamp (HGC) for assessment of glucose-dependent insulin secretion (GDIS) using exenatide as a probe.
Eligibility Criteria
Inclusion
- Subject has a Body Mass Index (BMI) of less than or equal to 26 kg/m2 at screening
- Subject is judged to be in good health
- Subject has been a nonsmoker for at least 3 months
- Subject is willing to avoid strenuous physical activity for the duration of the study
Exclusion
- Subject has a history of high blood pressure requiring treatment
- Subject has a history of diabetes or a family history of diabetes mellitus
- Subject is unable to discontinue all prescription and non-prescription drugs for duration of study
- Subject consumes more than 3 alcoholic beverages per day
- Subject consumes more than 6 servings of caffeinated beverages per day (1 serving = 120mg caffeine)
- Subject has had major surgery or has donated or loss 1 unit of blood within 4 weeks of screening
- Subject has multiple and/or severe allergies to foods or drugs
- Subject is a regular user of illegal drugs
- Subject is unwilling or unable to consume the standardized meals during the study and/or is on a carbohydrate restricted diet
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00782418
Start Date
September 1 2008
End Date
March 1 2009
Last Update
December 21 2016
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