Safety and efficacy of tirzepatide as an add-on to single oral antihyperglycaemic medication in patients with type 2 diabetes in Japan (SURPASS J-combo): a multicentre, randomised, open-label, parallel-group, phase 3 trial

What Was Tested

The paper reports a study of Tirzepatide, published as a randomized controlled trial.

Due to potential ethnic differences in the pathophysiology of type 2 diabetes, new therapeutics need to be evaluated in Japanese patients.

For the Japanese translation of the abstract see Supplementary Materials section.

Who Took Part

The primary endpoint was safety and tolerability during 52 weeks of treatment, assessed as incidence of treatment-emergent adverse events in the modified intention-to-treat (mITT) population.

How the Study Was Run

The design is described as randomized, double-blind, open-label, multicenter and parallel-group.

Because people in this Tirzepatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Blinding on both sides kept the participants and researchers unaware of who received Tirzepatide.

Everyone knew when Tirzepatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Running at several centres spread the Tirzepatide study over different clinics and patient groups.

The timeline in the abstract includes 52 weeks.

This multicentre, open-label, parallel-group, randomised, phase 3 trial was conducted at 34 medical research centres and hospitals in Japan.

This trial is registered with ClinicalTrials.gov, NCT03861039.

What Was Measured

Due to potential ethnic differences in the pathophysiology of type 2 diabetes, new therapeutics need to be evaluated in Japanese patients.

PubMed files the paper under topics including Diabetes Mellitus, Type 2, Gastric Inhibitory Polypeptide, Glucagon-Like Peptides, Hypoglycemic Agents, Japan and Tirzepatide.

What This Means in Plain Language

The paper is a randomized, double-blind and open-label study of Tirzepatide over 52 weeks.

Results are reported in around 9 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2022 (The lancet. Diabetes & endocrinology), a journal based in England.

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