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

NCT04537923 · Completed

Last updated 2026-05-28

This clinical trial compares the effects of tirzepatide to insulin lispro in adults with type 2 diabetes whose blood sugar is not well-controlled on insulin glargine, with or without metformin.

Status Completed The study has finished.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) treatment study

Participants 1,428 people

Who can join Ages 18+ · all sexes

Timeline Started 2020-10 · est. completion 2022-11

Where 135 sites · Argentina, Belgium, Brazil, Czechia, Germany, Greece, Hungary, Italy, Mexico, Puerto Rico, Romania, Russia, Slovakia, Spain, Turkey (Türkiye), United States

What this study is testing ClinicalTrials.gov NCT04537923 ↗

Description as written by the study sponsor.

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.

Treatments tested

Tirzepatide also known as LY3298176 Drug

Administered SC
Insulin Lispro (U100) also known as LY275585 Drug

Administered SC

Main thing measured	Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg)
Sponsor	Eli Lilly and Company
Conditions studied	Type 2 Diabetes
GLP-1 drugs	tirzepatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT04537923 ↗