CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 426 enrolled
Drug / intervention
Insulin lispro low mixture +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/NCT00548808
NCT00548808Phase 4Completed

Comparison of Insulin Lispro Low Mixture With Insulin Glargine When Initiating and Intensifying Insulin Therapy As Required in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Oral Antihyperglycemic Medication

Eli Lilly and Company·interventional·Posted Oct 24, 2007·Updated Sep 15, 2010

In Brief

A Phase 4 clinical trial evaluating Insulin lispro low mixture, Insulin glargine, and 1 other intervention for Type 2 Diabetes Mellitus. Completed, enrolled 426 participants across 25 sites in 7 countries.

Detailed Summary

The purpose of the study is to compare the insulin lispro low mixture (1, 2 or 3 daily injections) with insulin glargine (alone or with 1, 2 or 3 insulin lispro daily injections) on lowering the blood sugar level

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Brazil, Canada, China, India, Mexico, South Korea
Collaborators--

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 24, 2007
Enrollment StartNov 1, 2007
Primary CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 18.7 years ago

Interventions

Insulin lispro low mixturedrug

Dose depending on patient's need; subcutaneous injection before meal; start with once-daily injection before evening meal for 48 weeks, may add second injection before breakfast at any time during the treatment period if required, and may further add third injection before lunch at any time in the remainder of the treatment period if required.

Insulin glarginedrug

Dose depending on patient's need; one daily subcutaneous injection before bedtime for 48 weeks

Insulin lisprodrug

Dose depending on patient's need; subcutaneous injection before meal; may start once-daily injection before meal (e.g. lunch if the highest blood glucose value is measured before dinner) on top of insulin glargine at any time of the treatment period if required, and may further add second or even third injection in the remainder of the treatment period if required.