A Study to Compare Methodologies for Assessing Glucose-Dependent Insulin Secretion
Information source: Merck
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: The Methodology Assessment of Glucose Dependent Insulin Secretion.
Intervention: Comparator: exenatide (Drug); Comparator: exenatide (Drug); Comparator: Placebo (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
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.
Clinical Details
Official title: A Randomized Clinical Trial to Study Glucose Dependent Insulin Secretion Methodologies in Healthy Lean Male Subjects
Study design: Diagnostic, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Pharmacodynamics Study
Primary outcome: Comparison of GDIS measured after HGC at steady state to GDIS measured after GGI at the highest glucose infusion rate
Secondary outcome: Changes in C-peptide and plasma insulin concentrations measured by HGC
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
Merck Sharp & Dohme B.V., Bruxelles 1180, Belgium; Recruiting
Nathalie Schrameijer, Phone: 32-2-373-4310
Additional Information
Starting date: September 2008
Ending date: May 2009
Last updated: January 12, 2009
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