CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 374 enrolled
Drug / intervention
Insulin Glargine +2 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/NCT00666718
NCT00666718Phase 3Completed

A Prospective Randomized Trial to Compare Basal Bolus Therapies That Use Either Insulin Lispro Protamine Suspension or Insulin Glargine Together With Lispro Insulin in Patients With Type 2 Diabetes

Eli Lilly and Company·interventional·Posted Apr 25, 2008·Updated May 13, 2011

In Brief

A Phase 3 clinical trial evaluating Insulin Glargine, Insulin Lispro Protamine Suspension (ILPS), and 1 other intervention for Diabetes Mellitus, Type 2. Completed, enrolled 374 participants across 50 sites in 10 countries.

Detailed Summary

This study is designed to look at if a basal bolus regimen of insulin lispro protamine suspension (ILPS) provides the same glycemic control as a basal bolus regimen of insulin glargine (when one basal bolus regimen is injected once daily together with insulin lispro injected 2-3 times daily).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, Czechia, Germany, Greece, Italy, Poland, Romania, Slovakia, Turkey (Türkiye), United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 25, 2008
Enrollment StartApr 1, 2008
Primary CompletionFeb 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 18.2 years ago

Interventions

Insulin Glarginedrug

patient glucose-level dependent, injection, once daily in the evening, 24 weeks

Insulin Lispro Protamine Suspension (ILPS)drug

patient glucose-level dependent, injection, once daily in the evening, 24 weeks

Insulin Lisprodrug

subcutaneous injections prior to meals, 24 weeks