A Study to Compare Methodologies for Assessing Glucose-Dependent Insulin Secretion (0000-104)(COMPLETED)

NCT00782418 · Completed

Last updated 2026-05-28

This study compared different methods for measuring how the body releases insulin in response to blood sugar levels in healthy participants.

Status Completed The study has finished.

Phase Phase 1 Checks safety and dosing in a small group.

Type Interventional (clinical trial)

Design Randomized, double-blind diagnostic study

Participants 27 people

Who can join Ages 18–45 · male only Healthy volunteers accepted.

Timeline Started 2008-09 · est. completion 2009-03

What this study is testing ClinicalTrials.gov NCT00782418 ↗

Description as written by the study sponsor.

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.

Treatments tested

Comparator: exenatide also known as Byetta Drug

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.
Comparator: exenatide also known as Byetta Drug

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.
Comparator: Placebo Drug

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.

Main thing measured	Change From Baseline in Insulin Secretion Rate (ISR) Normalized to Ambient Plasma Glucose
Sponsor	Merck Sharp & Dohme LLC
Conditions studied	The Methodology Assessment of Glucose Dependent Insulin Secretion
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT00782418 ↗