CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 65 enrolled
Drug / intervention
exenatide once weekly +2 moredrug
Likely dose
exenatide once weekly 10.0 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/NCT00894322
NCT00894322Phase 2Completed
CompareCT.gov

A Two-Cohort, Single- and Repeat Dose Study to Examine the Pharmacokinetics, Tolerability, and Safety of Ready to Use Exenatide Once Weekly in Healthy Subjects and in Subjects With Type 2 Diabetes Mellitus

AstraZeneca·interventional·Posted May 7, 2009·Updated Sep 18, 2015

In Brief

A Phase 2 clinical trial evaluating exenatide once weekly and Placebo for Type 2 Diabetes Mellitus. Completed, enrolled 65 participants across 1 site.

Detailed Summary

This study is designed to evaluate the pharmacokinetics, tolerability, and safety of exenatide once weekly suspension in both healthy subjects and in subjects with type 2 diabetes. The study will also evaluate efficacy in the type 2 diabetes patients. Development of this exenatide once weekly presentation would eliminate the need to reconstitute the product prior to use.

Study Details

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

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 7, 2009
Enrollment StartApr 1, 2009
Primary CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 17.2 years ago

Interventions

exenatide once weeklydrug

subcutaneous injection, 10.0 mg, single injection

exenatide once weeklydrug

subcutaneous injection, 2.0 mg, once a week for 12 weeks

Placeboother

subcutaneous injection, volume equivalent to Cohort 2 experimental intervention, once a week for 12 weeks