CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 233 enrolled
Drug / intervention
exenatide +2 moredrug
Likely dose
exenatide 5 mcgfrom 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/NCT00381342
NCT00381342Phase 3Completed
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Safety and Efficacy of Exenatide as Monotherapy in Drug Naive Patients With Type 2 Diabetes

AstraZeneca·interventional·Posted Sep 27, 2006·Updated Feb 23, 2015

In Brief

A Phase 3 clinical trial evaluating exenatide and placebo for Type 2 Diabetes Mellitus. Completed, enrolled 233 participants across 19 sites in 5 countries.

Detailed Summary

This Phase 3 trial is designed to compare the effects of twice-daily exenatide and twice-daily placebo with respect to glycemic control in drug-naive patients with type 2 diabetes treated with diet and exercise.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesIndia, Puerto Rico, Romania, Russia, United States
CollaboratorsEli Lilly and Company

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 27, 2006
Enrollment StartSep 1, 2006
Primary CompletionSep 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 19.8 years ago

Interventions

exenatidedrug

Placebo subcutaneously injected twice daily as a lead-in followed by exenatide subcutaneously injected, 5 mcg, twice a day

exenatidedrug

Placebo subcutaneously injected twice daily as a lead-in followed by exenatide subcutaneously injected, 5 mcg, twice a day, then exenatide subcutaneous injection, 10 mcg twice a day

placebodrug

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