Conditions: The Methodology Assessment of Glucose Dependent Insulin Secretion
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 27
Healthy volunteers: yes

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.

Detailed description:

Arms:
arm 1: exenatide 5mcg arm 2: exenatide 1.5mcg arm 3: Placebo

Interventions: intervention 1: Comparator: exenatide intervention 2: Comparator: exenatide intervention 3: Comparator: Placebo
Intervention descriptions: intervention 1: exenatide in two 5mcg subcutaneous doses 120 minutes apart, followed by either HGC or GGI. After a 14 day washout period two additional 5mcg doses will be administered, followed by HCG or GGI. intervention 2: exenatide in two 1.5mcg subcutaneous doses 120 minutes apart, followed by either HGC or GGI. After a 14 day washout period two additional 1.5mcg doses will be administered, followed by HCG or GGI. intervention 3: 5% osmitrol in two 60 mcL subcutaneous doses 120 minutes apart, followed by either HGC or GGI. After a 14 day washout period two additional 60 mcL doses will be administered, followed by HCG or GGI.

Protocol document: