CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 484 enrolled
Drug / intervention
Insulin lispro mid mixture (MM) +1 moredrug
Likely dose
Insulin lispro mid mixture: patient-specific adjusted dose three times daily, subcutaneous; Insulin glargine: patient-specific adjusted dose once daily, subcutaneousAI-extracted
Key inclusion· 3
  • ✓Type 2 diabetes diagnosis
  • ✓Currently on ≥2 oral antihyperglycemic medications at maximally tolerated doses (metformin ≥1500 mg/day, OR sulfonylurea ≥1/2 max daily dose, OR TZD ≥30 mg pioglitazone or ≥4 mg rosiglitazone)
  • ✓HbA1c between 7.5% and 12.0%
Key exclusion· 7
  • ✕Use of TZD dose exceeding label recommendations for combination with insulin
  • ✕Use of glucose-lowering agents other than those specified (e.g., acarbose, miglitol, pramlintide, exenatide, repaglinide, nateglinide, or other unlisted agents)
  • ✕Recent or cumulative use of acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide (within 6 weeks or ≥30 days in last 24 weeks)
  • ✕Body mass index >40 kg/m²

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

Search/NCT00377858
NCT00377858Phase 4Completed
CompareCT.gov

Comparison of Two Approaches to Basal-Bolus Insulin Therapy in Patients With Type 2 Diabetes and Inadequate Glycemic Control on Oral Therapy: Comparison of Premixed Insulin Lispro Mid Mixture With Separate Basal and Bolus Insulin Injections

Eli Lilly and Company·interventional·Posted Sep 19, 2006·Updated Dec 9, 2009

In Brief

A Phase 4 clinical trial evaluating Insulin lispro mid mixture (MM) and Insulin glargine for Diabetes Mellitus, Type 2. Completed, enrolled 484 participants across 25 sites in 7 countries.

Detailed Summary

A study of patients with type 2 diabetes and inadequate glycemic control on two or more oral antihyperglycemic agents comparing adding insulin lispro mid mixture to the oral antihyperglycemic agents to adding insulin glargine to the oral antihyperglycemic agents.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesAustralia, Canada, France, Mexico, Russia, South Korea, Spain
Collaborators--

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 19, 2006
Enrollment StartAug 1, 2006
Primary CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 19.8 years ago

Interventions

Insulin lispro mid mixture (MM)drug

Patient specific adjusted dose, three times a day (TID), subcutaneous (SC) injection x 36 weeks

Insulin glarginedrug

Patient specific adjusted dose, every day (QD), subcutaneous (SC) injection x 36 weeks