Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2026-03-29 @ 6:50 AM
Study NCT ID:
NCT05413369
Status:
COMPLETED
Last Update Posted:
2025-09-24
First Post:
2022-06-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
iGlarLixi vs IDegAsp in Chinese Participants After OAD(s)
Sponsor:
Sanofi
Organization:
Study Overview
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
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U1111-1267-2772 | REGISTRY | ICTRP | View |