Completed
PHASE3
INTERVENTIONAL
NCT04537923
A Study of Tirzepatide (LY3298176) Versus Insulin Lispro (U100) in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine (U100) With or Without Metformin
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
The purpose of this study is to compare the safety and efficacy of the study drug tirzepatide to insulin lispro (U100) three times a day in participants with type 2 diabetes that are already on insulin glargine (U100), with or without metformin.
Interventions
Name:
Tirzepatide
Type:
DRUG
Description:
Administered SC
Name:
Insulin Lispro (U100)
Type:
DRUG
Description:
Administered SC
Primary Outcomes
Measure:
Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg)
TimeFrame:
Baseline, Week 52
Description:
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with covariates Baseline + Pooled Country + Baseline Metformin Use (Yes, No) + Treatment + Time + Treatment\*Time (Type III sum of squares).
Trial Information
NCT ID
NCT04537923
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE3
Sponsor
Eli Lilly and Company
Last Updated
December 15, 2025