Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2026-01-03 @ 9:38 PM
Study NCT ID:
NCT03703869
Status:
COMPLETED
Last Update Posted:
2022-04-25
First Post:
2018-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Twelve -Month Study Observing How Insulin-naïve Patients With Type 2 Diabetes Mellitus Manage Diabetes Using Toujeo® After Oral Antidiabetic Drug Failure, the Side Effect of Toujeo®, and The Cost.
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
A 12-month Prospective Observational Study Assessing the Real-world Clinical Effectiveness, Safety and Health-economic Benefits of Toujeo® Initiation After Oral Antidiabetic Drug Failure in Insulin-naïve Patients With Type 2 Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2022-04
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:
ATOS
Brief Summary:
Primary Objective:
Assess effectiveness of insulin glargine (U300) in achieving glycemic goal measured by hemoglobin A1c (HbA1c).
Secondary Objectives:
* Assess effectiveness in achieving glycemic goal measured by HbA1c;
* Assess effectiveness on change in HbA1c, fasting plasma glucose (FPG) and self-monitored plasma glucose (SMPG) ;
* Assess requirement for intensification of therapy by additional antidiabetics.
* Assess incidence of hypoglycemia;
* Assess other safety endpoints: adverse events (AEs), serious adverse events (SAEs);
* Assess change in body weight.
Assess effectiveness of insulin glargine (U300) in achieving glycemic goal measured by hemoglobin A1c (HbA1c).
Secondary Objectives:
* Assess effectiveness in achieving glycemic goal measured by HbA1c;
* Assess effectiveness on change in HbA1c, fasting plasma glucose (FPG) and self-monitored plasma glucose (SMPG) ;
* Assess requirement for intensification of therapy by additional antidiabetics.
* Assess incidence of hypoglycemia;
* Assess other safety endpoints: adverse events (AEs), serious adverse events (SAEs);
* Assess change in body weight.
Detailed Description:
Patients will be observed for one year
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 |
|---|---|---|---|---|
| U1111-1215-0174 | OTHER | UTN | View |