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A Study of LY2605541 in Participants With Type 1 Diabetes Mellitus

NCT01792284 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 212

Last updated 2018-04-20

Study results available
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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.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DRUG

LY2605541

DRUG

Insulin Lispro

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

Sponsors & Collaborators

Principal Investigators

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) · Eli Lilly and Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01792284 on ClinicalTrials.gov