iGlarLixi vs IDegAsp in Chinese Participants After OAD(s)
Summary
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
Timeline
- Start
- 2022-07-07
- Primary completion
- 2023-10-20
- Completion
- 2023-10-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | IDegAsp | Protein / enzyme biologic | — | Subcutaneous |
| Subject | Insulin glargine/Lixisenatide | Unknown | — | Subcutaneous |
| Background | Metformin | Small molecule | — | Oral |