iGlarLixi vs IDegAsp in Chinese Participants After OAD(s)
Status:
Not yet recruiting
Trial end date:
2024-03-22
Target enrollment:
Participant gender:
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.