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Comparison of Two Basal Insulins for Patients With Type 2 Diabetes (IOOY)

NCT00494013 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 442

Last updated 2009-11-11

Study results available
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Summary

The purpose of this study is to examine the effectiveness and safety of insulin lispro protamine suspension (ILPS) as compared to insulin detemir as basal insulin therapy in adults with type 2 diabetes. A gatekeeper strategy will be employed for sequentially testing the secondary objectives.

Conditions

  • Diabetes Mellitus Type 2

Interventions

DRUG

Insulin Lispro Protamine Suspension

Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.

DRUG

Detemir

Patient specific dose administered subcutaneously once or twice daily x 24 weeks.

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
2007-08-31
Primary Completion
2008-09-30
Completion
2008-09-30

Countries

  • United States
  • Argentina
  • Hungary
  • India
  • Mexico
  • Poland
  • South Korea
  • Spain
  • Taiwan

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 NCT00494013 on ClinicalTrials.gov