CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 255 enrolled
Drug / intervention
exenatide and sitagliptin +1 moredrug
Likely dose
exenatide and sitagliptin 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/NCT00870194
NCT00870194Phase 4Completed
CompareCT.gov

A Comparison of Adding Exenatide With Switching to Exenatide in Patients With Type 2 Diabetes Experiencing Inadequate Glycemic Control With Sitagliptin Plus Metformin

AstraZeneca·interventional·Posted Mar 27, 2009·Updated Apr 9, 2015

In Brief

A Phase 4 clinical trial evaluating exenatide and sitagliptin and exenatide and placebo for Type 2 Diabetes Mellitus. Completed, enrolled 255 participants across 36 sites in 7 countries.

Detailed Summary

The purpose of this study is to determine whether ceasing sitagliptin and switching to exenatide and metformin is non-inferior to adding exenatide to sitagliptin and metformin, in those patients with type 2 diabetes who are experiencing inadequate glycemic control with a combination of sitagliptin and metformin.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesArgentina, Australia, Germany, Greece, India, Mexico, South Korea
CollaboratorsEli Lilly and Company

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 27, 2009
Enrollment StartMar 1, 2009
Primary CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 17.3 years ago

Interventions

exenatide and sitagliptindrug

exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; sitagliptin-100mg tablet orally once a day

exenatide and placebodrug

exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; placebo-tablet orally once a day