CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 387 enrolled
Drug / intervention
Insulin Lispro Protamine Suspension +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00487240
NCT00487240Phase 3Completed
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Comparison of Two Basal Insulin Analogs (Insulin Lispro Protamine Suspension and Insulin Detemir) in Basal-Bolus Therapy for Patients With Type 1 Diabetes

Eli Lilly and Company·interventional·Posted Jun 18, 2007·Updated Nov 4, 2010

In Brief

A Phase 3 clinical trial evaluating Insulin Lispro Protamine Suspension and Insulin Levemir for Diabetes Mellitus, Type 1. Completed, enrolled 387 participants across 28 sites in 9 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 1
CountriesArgentina, Australia, Brazil, Greece, Hungary, Mexico, Romania, Russia, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 18, 2007
Enrollment StartJun 1, 2007
Primary CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 19.0 years ago

Interventions

Insulin Lispro Protamine Suspensiondrug

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

Insulin Levemirdrug

Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks