RecruitingPhase 4NCT06671587

iGlarLixi CGM Study in Chinese T2D Individuals After OADs

A 20-week, Multicenter, Prospective, Parallel-group Treatment, Open-label, 2-Arm, Phase 4, Randomized Study to Evaluate the Efficacy of iGlarLixi Versus Gla-100 on Glycemic Time in Range (TIR) From Continuous Glucose Monitoring (CGM) in Chinese Insulin Naïve Patients With Type 2 Diabetes (T2D) Inadequately Controlled With Oral Antidiabetics


Sponsor

Sanofi

Enrollment

678 participants

Start Date

Dec 10, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing iGlarLixi — a once-daily injectable combination of insulin and a GLP-1 receptor agonist — in Chinese adults with type 2 diabetes who are not achieving adequate blood sugar control with oral medications alone. The study uses a continuous glucose monitor (CGM) to track blood sugar levels throughout. **You may be eligible if...** - You have had type 2 diabetes for at least 1 year - You have been on a stable dose of metformin (alone or with one other oral diabetes drug) for at least 3 months and your blood sugar is not well controlled - Your BMI is between 20 and 40 - You are willing and able to wear a continuous glucose monitor **You may NOT be eligible if...** - You have severe kidney disease - You have another serious health condition that would interfere with the study - You are currently using a continuous glucose monitor for another purpose - You are unwilling to stop certain oral diabetes medications (sulfonylureas, DPP-4 inhibitors, etc.) during the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGiGlarLixi (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.

DRUGGla-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.


Locations(1)

Investigational Site Number: 1560001

Beijing, China

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NCT06671587


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