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A Study in Participants With Type 1 Diabetes Mellitus

NCT01481779 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 455

Last updated 2018-04-17

Study results available
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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.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DRUG

Glargine

Administered by SC injection via a pen device.

DRUG

LY2605541

Administered by SC injection with a pen device.

DRUG

Insulin Lispro

Administered by SC injection with a pen device.

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
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-05-31
Completion
2014-06-30

Countries

  • United States
  • Austria
  • France
  • Germany
  • Italy
  • Japan
  • Mexico
  • Poland
  • Russia

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 NCT01481779 on ClinicalTrials.gov