iGlarLixi vs IDegAsp in Chinese Participants After OAD(s)
NCT05413369 · Completed
Last updated 2026-05-28This clinical trial compares two diabetes treatments (iGlarLixi and IDegAsp) in Chinese adults with type 2 diabetes to see if one is as effective as the other in lowering blood sugar over 24 weeks.
What this study is testing ClinicalTrials.gov NCT05413369 ↗
Description as written by the study sponsor.
This was a parallel-group treatment, Phase 3, randomized, 2-arm study that assessed the efficacy and safety of iGlarLixi to IDegAsp in Chinese T2DM participants insufficiently controlled with oral antidiabetic drug(s). Study details included: * Study duration per participant: approximately up to 27 weeks * Treatment duration: 24 weeks * Visit frequency: after screening (an on-site visit), on-site or phone call visit every 1 week from randomization till Week 4, every 2 weeks till week 12 and then every 3 weeks till Week 24 (End of Treatment). There were 14 visits that included 7 phone calls and 7 on-site visits in total during screening and treatment periods. There was a safety follow-up by a phone call visit (End of Study) in 3 days after the last dose of the treatment. * Health measurement/Observation: change in HbA1c as the primary endpoint. * Intervention name: iGlarLixi and IDegAsp * Participant sex: male and female * Participant age range: adults at least 18 years of age * Condition/disease: Type 2 diabetes mellitus
Treatments tested
- Insulin glargine/Lixisenatide Drug
solution, by subcutaneous injection
- IDegAsp Drug
solution, by subcutaneous injection
- Metformin Drug
Tablet, orally
- SGLT2 inhibitor Drug
Tablet, orally
| Main thing measured | Change in HbA1c From Baseline to Week 24: Non-Inferiority Analysis |
|---|---|
| Sponsor | Sanofi |
| Conditions studied | Type 2 Diabetes Mellitus |
| GLP-1 drugs | — |
Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT05413369 ↗