NCT05413369

iGlarLixi vs IDegAsp in Chinese Participants After OAD(s)

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 582 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

27 weeks

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Insulin glargine/Lixisenatide	solution, by subcutaneous injection
DRUG	IDegAsp	solution, by subcutaneous injection
DRUG	Metformin	Tablet, orally
DRUG	SGLT2 inhibitor	Tablet, orally

Timeline

• Start date: 2022-07-07
• Primary completion: 2023-10-20
• Completion: 2023-10-20
• First posted: 2022-06-10
• Last updated: 2025-09-24
• Results posted: 2024-10-30

Locations

60 sites across 1 country: China

Regulatory

• FDA-regulated drug study