Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-27 @ 11:18 PM
Study NCT ID:
NCT05002933
Status:
COMPLETED
Last Update Posted:
2025-09-22
First Post:
2021-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Efficacy and Safety Study of Insulin Glargine U300 in Chinese Adult Patients With Uncontrolled Type 2 Diabetes Mellitus With a 3-month Extension Period
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
A 6-month, Multicenter, Prospective, Single-arm, Open-label, Phase IV Study Evaluating the Clinical Efficacy and Safety of Insulin Glargine U300 in Chinese Adult Patients With Uncontrolled Type 2 Diabetes Mellitus With a 3-month Extension Period
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:
INITIATION
Brief Summary:
This is a prospective, interventional, single arm, multicenter, phase 4 study to evaluate the clinical efficacy and safety of initiating Insulin glargine U300 in insulin-naive patients or switching from any other basal insulin to Insulin glargine U300 in insulin pre-treated patients with uncontrolled T2DM.
Detailed Description:
Maximum study duration per participant will be approximately 37 weeks per patient: up to 1 week screening period, 24 weeks insulin glargine U300 treatment period and 12 weeks observational extension period.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U1111-1251-4484 | REGISTRY | ICTRP | View |