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Comparison of Two Basal Insulin Therapies for Patients With Type 1 Diabetes

NCT00487240 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 387

Last updated 2010-11-04

Study results available
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Summary

The purpose of this study is to examine the efficacy and safety of insulin lispro protamine suspension (ILPS) as compared to insulin detemir as basal insulin combined with mealtime insulin therapy in patients with type 1 diabetes. A gatekeeper strategy will be employed for sequentially testing the secondary objectives.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DRUG

Insulin Lispro Protamine Suspension

Patient specific dose, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks.

DRUG

Insulin Levemir

Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 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
2007-06-30
Primary Completion
2008-08-31
Completion
2008-08-31

Countries

  • United States
  • Argentina
  • Australia
  • Brazil
  • Greece
  • Hungary
  • Mexico
  • Romania
  • 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 NCT00487240 on ClinicalTrials.gov