CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 774 enrolled
Drug / intervention
Dulaglutide +3 moredrug
Likely dose
Not stated in 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/NCT01648582
NCT01648582Phase 3Completed
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The Efficacy and Safety of Once-Weekly, Subcutaneous Dulaglutide Compared to Once-Daily Insulin Glargine in Patients With Type 2 Diabetes Mellitus on Metformin and/or a Sulfonylurea

Eli Lilly and Company·interventional·Posted Jul 24, 2012·Updated Sep 18, 2019

In Brief

A Phase 3 clinical trial evaluating Dulaglutide, Insulin glargine, and 2 other interventions for Type 2 Diabetes Mellitus. Completed, enrolled 774 participants across 30 sites in 4 countries.

Detailed Summary

The purpose of this study is to examine if once-weekly dulaglutide is efficient and safe compared to once-daily insulin glargine in participants with type 2 diabetes mellitus who have inadequate glycemic control with 1 or 2 oral antihyperglycemic medications (OAM) (metformin and/or a sulfonylurea), in addition to any healthy lifestyle changes recommended by their healthcare providers.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesChina, Mexico, Russia, South Korea
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 24, 2012
Enrollment StartJul 1, 2012
Primary CompletionAug 1, 2014
Study CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 13.9 years ago

Interventions

Dulaglutidedrug

Administered SC

Insulin glarginedrug

Administered SC per dosing titration schedule

Metformindrug

Administered orally at pre-study prescribed dose, and is not being provided as part of the trial.

Sulfonylureasdrug

Administered orally at pre-study prescribed dose, and is not being provided as part of the trial.