iGlarLixi vs IDegAsp in Chinese Participants After OAD(s)

Type 2 Diabetes Mellitus Clinical Trial

Official title: A Randomized, 24 Weeks, Active-controlled, Open-label, 2-arm Multicenter Study Comparing the Efficacy and Safety of iGlarLixi to IDegAsp in Chinese Type 2 Diabetes Mellitus Participants Insufficiently Controlled With Oral Antidiabetic Drug(s)

Status Completed

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 ;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

• NCT number: NCT05413369
• Study type: Interventional
• Source: Sanofi
• Status: Completed
• Phase: Phase 3
• Start date: July 7, 2022
• Completion date: October 20, 2023