CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 455 enrolled
Drug / intervention
Glargine +2 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/NCT01481779
NCT01481779Phase 3Completed
CompareCT.gov

The Impact of LY2605541 Versus Insulin Glargine for Patients With Type 1 Diabetes Mellitus Treated With Preprandial Insulin Lispro: An Open-Label, Randomized, 78-Week Study - The IMAGINE 1 Study

Eli Lilly and Company·interventional·Posted Nov 30, 2011·Updated Apr 17, 2018

In Brief

A Phase 3 clinical trial evaluating Glargine, LY2605541, and 1 other intervention for Diabetes Mellitus, Type 1. Completed, enrolled 455 participants across 51 sites in 9 countries.

Detailed Summary

The purpose of this study is: * To compare the blood sugar control of LY2605541 with insulin glargine after 78 weeks of treatment. * To compare the rate of night-time low blood sugar episodes on LY2605541 with insulin glargine during 78 weeks of treatment. * To compare the number of participants on LY2605541 reaching blood sugar targets without low blood sugar episodes at night to those taking insulin glargine after 78 weeks of treatment. * To compare the rate of hypoglycemia episodes on LY2605541 with insulin glargine during 78 weeks of treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 1
CountriesAustria, France, Germany, Italy, Japan, Mexico, Poland, Russia, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 30, 2011
Enrollment StartJan 1, 2012
Primary CompletionMay 1, 2013
Study CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 14.6 years ago

Interventions

Glarginedrug

Administered by SC injection via a pen device.

LY2605541drug

Administered by SC injection with a pen device.

Insulin Lisprodrug

Administered by SC injection with a pen device.