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A Study to Compare a New Long-Acting Insulin (LY2605541) and Human Insulin NPH in Participants With Type 2 Diabetes

NCT01790438 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 641

Last updated 2018-05-03

Study results available
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Summary

The purpose of this study is to compare LY2605541 and human insulin isophane suspension (NPH) using the following measures for participants treated for up to 26 weeks:

* Change in participants' overall blood sugar control
* The rate of night time low blood sugar episodes
* The number of participants that reach blood sugar targets without low night time blood sugar episodes
* The total number of low blood sugar episodes reported

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

LY2605541

DRUG

Human Insulin NPH

DRUG

Oral Antihyperglycemic Medications (OAM)

Sponsors & Collaborators

Principal Investigators

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM-5PM 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
2013-03-31
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • United States
  • Argentina
  • Canada
  • Czechia
  • Germany
  • Hungary
  • Mexico
  • Poland
  • Puerto Rico
  • South Korea
  • Spain

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 NCT01790438 on ClinicalTrials.gov