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iGlarLixi CGM Study in Chinese T2D Individuals After OADs

NCT06671587 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 678

Last updated 2026-03-17

No results posted yet for this study

Summary

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). The randomization (1:1) will be stratified by values of HbA1c at screening (\<8.0%, ≥8.0%), and background treatment (metformin only, metformin+SGLT-2i).

Study details include:

* The study duration per participant will be approximately up to 24 weeks.
* The treatment duration will be up to 20 weeks.
* The number of visits will be 14 visits including 9 times of on-site visits and 5 times of phone call visits in total during screening and treatment periods. On-site every 1 week will be from screening till randomization (Week 0), then on site or phone call visit every 2 weeks till Week 12, then every 3 weeks till Week 18, and the End of Treatment visit will be conducted at Week 20. There will be a safety follow-up by a phone call visit (End of Study) in 3 days (-1/+3 days) after the last dose of the treatment.
* Health measurement/Observation: change in TIR as the primary endpoint
* Intervention name: iGlarLixi and Gla-100
* Participant gender: male and female
* Participant age range: adults at least 18 years of age
* Condition/disease: type 2 diabetes
* Study hypothesis: compared to Gla-100, iGlarLixi will demonstrate a superiority therapeutic effect on glycemic control assessed by change in TIR measured with CGM from baseline to Week 20 in the study participants.

Conditions

  • Type 2 Diabetes (T2D)

Interventions

DRUG

iGlarLixi (insulin glargine/lixisenatide)

iGlarLixi will be supplied as a sterile aqueous solution in a pen-injector. There will be 2 pen-injectors with different insulin glargine/lixisenatide fixed ratios which allow insulin glargine titration from 5 U/day to 40 U/day while limiting lixisenatide dose to a maximum of 20 μg/day: \- iGlarLixi must not be mixed with other insulins nor diluted.

DRUG

Gla-100 (insulin glargine)

Gla-100 will be supplied as a 3 mL sterile aqueous solution for SC injection in a pre-filled disposable Gla-100 SoloStar® pen containing 300 U insulin glargine (100 U/mL). Doses could be set in the range of 5 to 80 U in increments of 1 unit.

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-10
Primary Completion
2026-09-18
Completion
2026-09-18

Countries

  • China

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06671587 on ClinicalTrials.gov