CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,114 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/NCT01454284
NCT01454284Phase 3Completed

The Impact of LY2605541 Versus Insulin Glargine for Patients With Type 1 Diabetes Mellitus Treated With Preprandial Insulin Lispro: a Double-Blind, Randomized, 52-week Study

Eli Lilly and Company·interventional·Posted Oct 18, 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 1,114 participants across 119 sites in 20 countries.

Detailed Summary

The purpose of this study is: * To compare blood sugar control on LY2605541 with insulin glargine after 52 weeks of treatment. * To compare the rate of nocturnal low blood sugar episodes on LY2605541 with insulin glargine during 52 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 52 weeks of treatment. * To compare the rate of low blood sugar episodes on LY2605541 with insulin glargine during 52 weeks of treatment

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Belgium, Brazil, Canada, Croatia, Denmark, France, Greece, Ireland, Israel, Lithuania, Netherlands, New Zealand, Poland, Slovakia, South Africa, Spain, Sweden, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 18, 2011
Enrollment StartJan 1, 2012
Primary CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 14.7 years ago

Interventions

Glarginedrug

LY2605541drug

Insulin Lisprodrug