drugset / Trial / NCT05413369

iGlarLixi vs IDegAsp in Chinese Participants After OAD(s)

NCT05413369

Phase 3 Completed 582 enrolled Sanofi
RandomizedParallel-groupOpen-labelTreatment

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

EvaluationDrugModalityDoseRoute
Comparator IDegAsp Protein / enzyme biologic Subcutaneous
Subject Insulin glargine/Lixisenatide Unknown Subcutaneous
Background Metformin Small molecule Oral