A Study of Tirzepatide (LY3298176) Versus Placebo in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine With or Without Metformin

NCT04039503 · Completed

Last updated 2026-05-28

This clinical trial is testing the medication tirzepatide against a placebo in adults with type 2 diabetes whose blood sugar is not well-controlled by 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, double-blind treatment study

Participants 475 people

Who can join Ages 18+ · all sexes

Timeline Started 2019-08 · est. completion 2021-01

Where 48 sites · Czechia, Germany, Japan, Poland, Puerto Rico, Slovakia, Spain, United States

What this study is testing ClinicalTrials.gov NCT04039503 ↗

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 placebo in participants with type 2 diabetes that are already on insulin glargine, with or without metformin. Participants will administer tirzepatide or placebo along with their previous glucose lowering medications. The study will last approximately 47 weeks and may include about 23 visits.

Treatments tested

Tirzepatide also known as LY3298176 Drug

Administered SC as add-on to the pre-trial background medication.
Placebo Drug

Administered SC as add-on to the pre-trial background medication.

Main thing measured	Change From Baseline in Hemoglobin A1c (HbA1c) (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 NCT04039503 ↗