CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 377 enrolled
Drug / intervention
Exenatide once weekly suspension +1 moredrug
Likely dose
Exenatide once weekly suspension 2 mgfrom 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/NCT01652716
NCT01652716Phase 3Completed
CompareCT.gov

A Randomized, Open-Label, Long-Term, Parallel-Group, Comparator-Controlled, Multicenter Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly Suspension to Exenatide Twice Daily in Subjects With Type 2 Diabetes Mellitus

AstraZeneca·interventional·Posted Jul 30, 2012·Updated Jul 3, 2018

In Brief

A Phase 3 clinical trial evaluating Exenatide once weekly suspension and Exenatide twice daily for Diabetes Mellitus, Type 2. Completed, enrolled 377 participants across 58 sites.

Detailed Summary

To compare the effect on glycemic control (HbA1c) of exenatide suspension administered once weekly to that achieved by exenatide administered twice daily for 28 weeks in subjects with type 2 diabetes mellitus. To examine the long-term (52 weeks of treatment) safety and effect on glucose control of exenatide suspension administered once weekly in subjects with type 2 diabetes mellitus.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 30, 2012
Enrollment StartJan 1, 2013
Primary CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 13.9 years ago

Interventions

Exenatide once weekly suspensiondrug

Exenatide suspension 2 mg weekly subcutaneous injection

Exenatide twice dailydrug

5 mcg twice daily for 4 weeks followed by 10 mcg twice daily for 24 weeks