iGlarLixi CGM Study in Chinese T2D Individuals After OADs

What Was Tested

This registered phase 4 trial tested Insulin Glargine and Lixisenatide.

This study is an open-label, 1:1 randomized, active-controlled, 2-arm, 20-week treatment duration, parallel-group, multicenter, phase IV study to evaluate the effect of iGlarLixi versus Gla-100 on glycemic control measured as TIR from CGM device in Chinese insulin naïve patients with T2D inadequately controlled with OADs.

At the end of the screening period, eligible participants will be randomized to one of two treatment groups (iGlarLixi or Gla-100 group).

It had two arms (groups): iGlarLixi (insulin glargine/lixisenatide) (experimental) and Gla-100 (insulin glargine) (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 678 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: Participants who are diagnosed as T2D of at least 1 year before screening visit. Body mass index (BMI) within the range 20-40 kg/m2 (inclusive). Is willing and able to wear the CGM device continuously. Is willing to discontinue daily (oral) SU, glinide, alpha-GI, and DPP-4i. Not using another CGM device during the study.

The full record lists 7 inclusion and 15 exclusion criteria; among the exclusions: participants with severe renal dysfunction; participants with short life expectancy; an episode of severe hypoglycemia requiring the assistance of a third party within 3 months before 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 2024-12-10 with completion listed for 2026-09-18.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 30 secondary outcomes, for example 2c Change (mg/dL) in mean daily glucose, Change (%) in coefficient of variation (CV), Change (%) in time below range (TBR), Change in mean glucose standard deviation (SD), Change (%) in glucose management indicator (GMI) and Change (%) in HbA1c.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine and Lixisenatide in 678 people.

With 678 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.