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

Plain-language guide to NCT04537923: phase 3 randomized trial of Tirzepatide and Insulin Lispro, 1428 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT04537923
Phase: phase 3
Status: completed
Start: 2020-10-19
Completion (planned or actual): 2022-10-11
Participants: 1428 (actual)
Design: randomized, open label (everyone knows who gets what), treatment
Conditions studied: Type 2 Diabetes
Results posted: yes

What This Study Did, in Plain Language

What Was Tested

In this phase 3 trial, researchers set out to test Tirzepatide and Insulin Lispro.

It had four arms (groups): one (experimental), one (experimental), one (experimental) and Insulin Lispro (active comparator).

The registry classes the interventions as drug.

Who Took Part

1428 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Have been diagnosed with type 2 diabetes mellitus (T2DM). Have a BMI ≥23 kilograms per meter squared (kg/m²) and ≤45 kg/m² at screening.

The full record lists 5 inclusion and 8 exclusion criteria; among the exclusions: have type 1 diabetes mellitus; have had chronic or acute pancreatitis any time prior to study entry; have proliferative diabetic retinopathy or diabetic macular edema or nonproliferative diabetic retinopathy requiring immediate or urgent treatment.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Tirzepatide and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Tirzepatide study: the participants and staff both knew the treatment.

It started in 2020-10-19 with completion listed for 2022-10-11.

It ran at 135 sites in United States (40), Brazil (15), Argentina (12), Romania (12), Germany (9) and Russia (8).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 9 secondary outcomes, for example Change From Baseline in HbA1c, Change From Baseline in Body Weight, Change From Baseline in Fasting Serum Glucose, Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG) Values, Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score and Change From Baseline in 36-Item SF-36 Mental Component Summary (MCS) Score.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Tirzepatide and Insulin Lispro in 1428 people.

With 1428 participants it is a large trial for this field.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Tirzepatide compound page and the Insulin Lispro compound page, all human trials.

Our Notes on the Compounds

Tirzepatide: A prescription peptide medicine that acts on both the GIP and GLP-1 receptors; Mounjaro and Zepbound contain the same active ingredient.

Insulin Lispro: A rapid-acting mealtime insulin analog; brands include Humalog, Admelog and Lyumjev.

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.