Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2025-12-24 @ 11:07 PM
NCT ID:
NCT05413369
Brief 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
Study:
NCT05413369
Study Brief:
Protocol Section:
NCT05413369