CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 212 enrolled
Drug / intervention
LY2605541 +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/NCT01792284
NCT01792284Phase 3Completed
CompareCT.gov

A Comparison of LY2605541 Once Daily at a Fixed Time With LY2605541 Variable Time of Dosing in Participants With Type 1 Diabetes Mellitus: An Open Label, Randomized, Crossover Study

Eli Lilly and Company·interventional·Posted Feb 15, 2013·Updated Apr 20, 2018

In Brief

A Phase 3 clinical trial evaluating LY2605541 and Insulin Lispro for Type 1 Diabetes Mellitus. Completed, enrolled 212 participants across 18 sites in 2 countries.

Detailed Summary

The primary purpose of participation in this study is to compare the safety and efficacy of different dosing schedules of LY2605541 and how different dosing schedules of LY2605541 affect Hemoglobin A1c (HbA1c). Participants will be treated for up to 36 weeks with LY2605541 (one 12-week Lead-in period and two 12-week Randomization periods) and will participate in a total of 42 weeks of total study enrollment, including a 2-week Screening period and a 4-week Follow-up period.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes Mellitus
CountriesPuerto Rico, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 15, 2013
Enrollment StartFeb 1, 2013
Primary CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 13.4 years ago

Interventions

LY2605541drug

Insulin Lisprodrug

All participants will be administering insulin lispro SQ as their pre-meal insulin during the course of the trial.