Evaluating iGlarLixi for managing Type 2 Diabetes in Chinese patients
Official title: 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
Run by Sanofi · NCT06671587 · Data updated 2026-11-12
This study is testing whether a new diabetes treatment called iGlarLixi can help Chinese patients with Type 2 Diabetes better control their blood sugar compared to a standard medication.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 678 (estimated) |
| Sponsor | Sanofi Industry-sponsored |
| Locations | 1 site (Beijing) |
| Status | Recruiting |
| Started | December 10, 2024 |
| Main results expected | September 18, 2026 |
| Study ends | September 18, 2026 |
| Registry record updated | March 17, 2026 |
| Trial ID | NCT06671587 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are Chinese individuals diagnosed with Type 2 Diabetes for at least one year, currently on stable doses of metformin or a combination of metformin and another oral antidiabetic drug.
✕Probably not a fit
Patients with severe renal dysfunction, short life expectancy, or a history of significant pancreatitis may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This open-label, randomized, active-controlled study aims to compare the effects of iGlarLixi and Gla-100 on glycemic control in Chinese patients with Type 2 Diabetes who are inadequately controlled on oral antidiabetic medications. Participants will be randomly assigned to one of the two treatment groups and monitored over a 20-week period using continuous glucose monitoring (CGM) devices. The study will include 14 visits, with a combination of on-site and phone consultations to ensure comprehensive data collection and patient support throughout the treatment duration.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for managing Type 2 Diabetes in patients who are not adequately controlled with oral medications.
How similar studies have gone: Other studies have shown promising results with similar GLP-1 receptor agonist approaches, indicating potential for success in this trial.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants who are diagnosed as T2D of at least 1 year before screening visit * Participants who are treated at least 3 months prior to screening visit with a stable dose of metformin alone or in combination with a second OAD * Inadequate control * 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 Exclusion Criteria: * Participants with severe renal dysfunction * Participants with short life expectancy * Participants with conditions/concomitant diseases making them non evaluable for the efficacy endpoints * Participants with conditions/concomitant diseases precluding their safe participation in this study * An episode of severe hypoglycemia requiring the assistance of a third party within 3 months before screening visit * History of clinically significant pancreatitis or severe gastrointestinal disorders * Participants who have any history of severe multiple allergies or an allergy resulting in anaphylaxis, or contraindication/hypersensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study * Previous treatment with insulin * Use of any glucose-lowering agents other than metformin alone or in combination with a second OAD (can be a SU, a glinide, an alpha-GI, a DPP-4i, or a SGLT-2i) * Use of systemic glucocorticoids * Use of weight loss drugs * History of discontinuation of a previous treatment with GLP-1 RA for safety/tolerability reasons or lack of efficacy * Laboratory findings at the screening visit * Participants have any current or previous skin conditions * Participants unwilling or unable to do blood glucose monitoring using the Sponsor-provided blood glucometer at home The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Where it's running
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Investigational Site Number: 1560001
Beijing, China Recruiting
Study contacts
- Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)
- Email: contact-us@sanofi.com
- Phone: 800-633-1610
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.