CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 27 enrolled
Drug / intervention
Comparator: exenatide +2 moredrug
Likely dose
Comparator: exenatide 5mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00782418
NCT00782418Phase 1Completed
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A Randomized Clinical Trial to Study Glucose Dependent Insulin Secretion Methodologies in Healthy Lean Male Subjects

Merck Sharp & Dohme LLC·interventional·Posted Oct 31, 2008·Updated Dec 21, 2016

In Brief

A Phase 1 clinical trial evaluating Comparator: exenatide and Comparator: Placebo for The Methodology Assessment of Glucose Dependent Insulin Secretion. Completed, enrolled 27 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsThe Methodology Assessment of Glucose Dependent Insulin Secretion
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 31, 2008
Enrollment StartSep 1, 2008
Primary CompletionFeb 1, 2009
Study CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 17.7 years ago

Interventions

Comparator: exenatidedrug

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: exenatidedrug

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: Placebodrug

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.