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 on ClinicalTrials.gov · last registry update 2023-11-02

An unusually large phase 3: 1,428 participants, more than double the 424 typical for the stage. The sponsor logged completion for 11 October 2022. Primary outcome, as filed: Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg). tirzepatide is already approved in the US for type 2 diabetes, so this is asking a further question rather than establishing the drug works at all.

Status: COMPLETED
Phase: P3
Drug: tirzepatide
Mounjaro, Zepbound
Sponsor: Eli Lilly and Company
Sponsor type: Industry
Enrollment: 1,428
Started: 2020-10-19
Primary completion: 2022-10-11 actual

Observed history

No changes recorded since monitoring began on 2026-08-21. This record has held steady. If a reporting date moves, a status changes or enrollment is resized, it will appear here with the previous value alongside the new one.

Primary outcome

Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg)

Conditions studied

Type 2 Diabetes

Every field above is taken directly from the registry record. See all detected changes across the class, or the tirzepatide page for this molecule’s full trial and approval history.