CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 196 enrolled
Drug / intervention
exenatide +1 moredrug
Likely dose
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/NCT00375492
NCT00375492Phase 3Completed
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Effect on Weight Loss of Exenatide Versus Placebo in Subjects With Type 2 Diabetes Participating in a Lifestyle Modification Program

AstraZeneca·interventional·Posted Sep 13, 2006·Updated Apr 7, 2015

In Brief

A Phase 3 clinical trial evaluating exenatide and placebo for Type 2 Diabetes Mellitus. Completed, enrolled 196 participants across 10 sites.

Detailed Summary

This trial is designed to compare the effects of twice-daily exenatide and twice-daily placebo on weight loss. This trial will evaluate overweight and obese subjects with type 2 diabetes who have inadequate glycemic control with metformin, sulfonylurea, or metformin plus a sulfonylurea. Subjects will be treated with exenatide or placebo in addition to their current oral antidiabetes agent regimen and participate in a lifestyle modification program.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesUnited States
CollaboratorsEli Lilly and Company

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 13, 2006
Enrollment StartSep 1, 2006
Primary CompletionFeb 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 19.8 years ago

Interventions

exenatidedrug

subcutaneous injection, 5mcg or 10mcg, twice a day

placebodrug

subcutaneous injection, volume equivalent to exenatide dose, twice a day