Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT06671587

iGlarLixi CGM Study in Chinese T2D Individuals After OADs

Led by Sanofi · Updated on 2026-03-17

678

Participants Needed

1

Research Sites

92 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

iGlarLixi CGM Study in Chinese T2D Individuals After OADs

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with type 2 diabetes for at least 1 year before screening
  • Treated with a stable dose of metformin alone or with a second oral antidiabetic drug for at least 3 months prior to screening
  • Inadequate blood sugar control
  • Body mass index (BMI) between 20 and 40 kg/m2 inclusive
  • Willing and able to wear a continuous glucose monitoring (CGM) device continuously
  • Willing to stop daily use of sulfonylurea, glinide, alpha-glucosidase inhibitors, and DPP-4 inhibitors
  • Not using any other CGM device during the study
Not Eligible

You will not qualify if you...

  • Severe kidney problems
  • Short life expectancy
  • Medical conditions making it impossible to evaluate treatment effectiveness
  • Conditions that would make participation unsafe
  • Severe hypoglycemia requiring help from others within 3 months before screening
  • History of significant pancreatitis or severe digestive disorders
  • History of severe multiple allergies, anaphylaxis, or allergies to study treatments
  • Previous insulin treatment
  • Use of glucose-lowering drugs other than metformin alone or with one other oral drug
  • Use of systemic steroids
  • Use of weight loss drugs
  • Previous stopping of GLP-1 receptor agonist treatment due to safety or lack of effectiveness
  • Abnormal lab test results at screening
  • Current or past skin conditions
  • Unwilling or unable to perform blood glucose monitoring with the provided device at home

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Investigational Site Number: 1560001

Beijing, China, 100730

Actively Recruiting

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Research Team

T

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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