Efficacy and Safety of iGlarLixi Versus Standard of Care in a Real-world Adult China Population With Uncontrolled Type 2 Diabetes on Oral Agents

What Was Tested

In this phase 4 trial, researchers set out to test Insulin Glargine and Lixisenatide.

This study is a prospective, open-label, multicenter, parallel-group, positive-controlled, and pragmatic randomized clinical trial (pRCT).

It had two arms (groups): iGlarLixi group (experimental) and Standard of care (SOC) group. (active comparator).

The investigational drug is iGlarLixi. Participants will receive subcutaneous injections of iGlarLixi with the OAD treatment regimen being appropriately maintained or adjusted as intensification therapy in routine clinical practice.

The control drug treatment is standard of care (basal insulin or premixed insulin, excluding any GLP-1 receptor agonist-containing drugs). Participants will receive standard of care with the OAD treatment regimen being maintained or appropriately adjusted as an intensification treatment during routine clinical practice.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 1316 planned participants were the target.

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: Participant must be at least 18 of age inclusive, at the time of signing the informed consent. Type 2 diabetes mellitus diagnosis. Further intensification with an additional antidiabetic injectable medication is indicated to achieve glycaemic target at the discretion of the study physician according to approval labelling.

The full record lists 5 inclusion and 10 exclusion criteria; among the exclusions: diagnosed with t1dm; BMI \<20 kg/m2 or BMI ≥40 kg/m2; participants who involved in other clinical trial within 3 months prior to the time of screening visit.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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

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

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

It started in 2025-12-13 with completion listed for 2027-06-30.

It ran at 24 sites in China (24).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): hemoglobin A1c (HbA1c) change (time frame: from baseline to week 24).

It also tracked 23 secondary outcomes, for example Change in weight from baseline to week 24, Change in Fasting plasma glucose from baseline to Week 24, Change in 7-point self-monitored plasma glucose (SMPG) profile from baseline to Week 24 (each time point and average daily value), Change in CGM metrics(TIR / TAR / TBR /mean daily glucose / TITR / CV / GMI / SD of mean glucose) from baseline to Week 24, Change in proportion of patients achieving CGM metrics targets (TIR / TAR / TBR / TITR / CV) from baseline to Week 24 and Change in waist from baseline to Week 24.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine and Lixisenatide in 1316 people.

With 1316 participants it is a large trial for this field.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Glargine compound page and the Lixisenatide compound page, all human trials.