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Clinical Trial Summary

This is a parallel-group treatment, Phase 3, randomized, 2-arm study to assess the efficacy and safety of iGlarLixi to IDegAsp in Chinese T2DM participants insufficiently controlled with oral antidiabetic drug(s). Study details include: - 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 will be 14 visits including 7 phone call and 7 on-site visits in total during screening and treatment periods. There will be 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 - Study hypothesis: Compared to IDegAsp, iGlarLixi will demonstrate a similar therapeutic effect on glycemic control assessed by change in HbA1c from baseline to Week 24 in the study participants.

Clinical Trial Description

27 weeks ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05413369
Study type Interventional
Source Sanofi
Contact Trial Transparency email recommended (Toll free for US & Canada)
Phone 800-633-1610
Email [email protected]
Status Recruiting
Phase Phase 3
Start date July 7, 2022
Completion date March 22, 2024

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