A Study in Participants With Type 2 Diabetes Mellitus

NCT01468987 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1369

Last updated 2018-04-17

Study results available
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Summary

The purpose of this study is:

* To compare blood glucose (blood sugar) control on LY2605541 with insulin glargine after 26 weeks of treatment.
* To compare the rate of night time hypoglycemia (low blood glucose) on LY2605541 with insulin glargine during 26 weeks of treatment.
* To compare the number of participants on LY2605541 reaching blood glucose targets without hypoglycemia episodes at night to those taking insulin glargine after 26 weeks of treatment.
* To compare the rate of hypoglycemia over a 24-hour period on LY2605541 with insulin glargine during 26 weeks of treatment.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

LY2605541

DRUG

Insulin Glargine

DRUG

Insulin Lispro

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
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • United States
  • Australia
  • Austria
  • Brazil
  • Croatia
  • Czechia
  • Denmark
  • Germany
  • Greece
  • Hungary
  • Israel
  • Italy
  • Japan
  • Lithuania
  • Mexico
  • Netherlands
  • Poland
  • Puerto Rico
  • Romania
  • Russia
  • Slovakia
  • Spain
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

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Entities

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 NCT01468987 on ClinicalTrials.gov