NCT06671587RecruitingPhase 4
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
Source: ClinicalTrials.gov · Last updated 17 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 678 (estimated)
- First submitted
- 31 Oct 2024
- Start date
- 10 Dec 2024
- Primary completion date
- 18 Sept 2026
- Lead sponsor
- Sanofi
- Diseases
- Type 2 diabetes
- NCT number
- NCT06671587
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 678
- From 10 Dec 2024 to the primary completion date, 18 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Previous treatment with insulin
- Use of weight loss drugs
- History of discontinuation of a previous treatment with GLP-1 RA for safety/tolerability reasons or lack of efficacy
- Participants have any current or previous skin conditions
Other illness
- 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
Lab values
- 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)
- Laboratory findings at the screening visit
- 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.
Other
- Participants with severe renal dysfunction
- Participants with short life expectancy
- Use of systemic glucocorticoids
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.