Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2026-03-08 @ 1:48 AM
Study NCT ID:
NCT02688933
Status:
COMPLETED
Last Update Posted:
2022-03-28
First Post:
2016-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Comparing the Efficacy and Safety of the Morning Injection of Toujeo Versus Lantus in Patients With Type 1 Diabetes Mellitus
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
A Randomized, Active-controlled, Parallel Group, 16-Week Open Label Study Comparing the Efficacy and Safety of the Morning Injection of Toujeo (Insulin Glargine-U300) Versus Lantus in Patients With Type 1 Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2022-03
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:
Primary Objective:
To demonstrate that morning injection of Toujeo (HOE901-U300) compared to Lantus provides better glycemic control evaluated by Continuous Glucose Monitoring (CGM) in adult participants with type 1 diabetes mellitus.
Secondary Objective:
To demonstrate that treatment with HOE901-U300 compared to Lantus provides:
* Lower incidence rate of nocturnal symptomatic hypoglycemia;
* Better glucose control coverage during the last hours of CGM before next basal-insulin dosing;
* Less variability in CGM profile.
To demonstrate that morning injection of Toujeo (HOE901-U300) compared to Lantus provides better glycemic control evaluated by Continuous Glucose Monitoring (CGM) in adult participants with type 1 diabetes mellitus.
Secondary Objective:
To demonstrate that treatment with HOE901-U300 compared to Lantus provides:
* Lower incidence rate of nocturnal symptomatic hypoglycemia;
* Better glucose control coverage during the last hours of CGM before next basal-insulin dosing;
* Less variability in CGM profile.
Detailed Description:
The maximum study duration per participant was to be of approximately 20 weeks that consisted of an up to a 4-week screening and CGM training period including a 1-2 week baseline (blinded) CGM performance (allowed for re-training), a 14-week open-label, comparative treatment period allowing for dose titration in both basal and meal-time insulin and including a 1-2 week end-of treatment blinded CGM collection with fixed dose of HOE901-U300 and Lantus, and a 2 day post treatment follow-up period.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U1111-1176-0936 | OTHER | UTN | View |