CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,538 enrolled
Drug / intervention
Glargine +1 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/NCT01435616
NCT01435616Phase 3Completed

A Comparison of LY2605541 Versus Insulin Glargine as Basal Insulin Treatment in Combination With Oral Anti-Hyperglycemia Medications in Insulin-Naive Patients With Type 2 Diabetes Mellitus: A Double-Blind, Randomized Study

Eli Lilly and Company·interventional·Posted Sep 16, 2011·Updated Apr 13, 2018

In Brief

A Phase 3 clinical trial evaluating Glargine and LY2605541 for Diabetes Mellitus, Type 2. Completed, enrolled 1,538 participants across 167 sites in 23 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 night time 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 after 52 weeks of treatment

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Australia, Brazil, Canada, Finland, Germany, Greece, Hungary, Israel, Italy, Lithuania, Mexico, New Zealand, Poland, Puerto Rico, Romania, Russia, Slovakia, South Africa, Spain, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 16, 2011
Enrollment StartNov 1, 2011
Primary CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 14.8 years ago

Interventions

Glarginedrug

LY2605541drug