CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 514 enrolled
Drug / intervention
exenatide once weekly +4 moredrug
Likely dose
exenatide once weekly 2.0mgfrom 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/NCT00637273
NCT00637273Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind, Parallel-Group, Multicenter Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Long-Acting Release(Once Weekly) to Those of Sitagliptin and a Thiazolidinedione in Subjects With Type 2 Diabetes Mellitus Treated With Metformin

AstraZeneca·interventional·Posted Mar 17, 2008·Updated Apr 7, 2015

In Brief

A Phase 3 clinical trial evaluating exenatide once weekly, sitagliptin, and 3 other interventions for Type 2 Diabetes Mellitus. Completed, enrolled 514 participants across 62 sites in 3 countries.

Detailed Summary

This study will compare the benefits of exenatide once weekly treatment to those achieved by the approved antidiabetic therapies sitagliptin and pioglitazone in subjects whose type 2 diabetes is managed with metformin therapy alone. The safety and tolerability of the three treatment regimens will also be compared.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesIndia, Mexico, United States
CollaboratorsEli Lilly and Company

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 17, 2008
Enrollment StartJan 1, 2008
Primary CompletionFeb 1, 2009
Study CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 18.3 years ago

Interventions

exenatide once weeklydrug

subcutaneous injection, 2.0mg, once a week

sitagliptindrug

oral tablet, 100mg, once a day

pioglitazonedrug

oral tablet, 45mg, once a day

placebo tabletdrug

oral tablet, once a day

placebo once weeklydrug

subcutaneous injection, once a week