Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2025-12-25 @ 8:22 PM
Study NCT ID:
NCT01127269
Status:
COMPLETED
Last Update Posted:
2014-07-17
First Post:
2010-05-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Effectiveness Study of Insulin Glargine (LANTUS) Initiation and Titration in Patients With Type 2 Diabetes
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
Practical Implementation of ADA/EASD Consensus Algorithm in Patients With Type 2 Diabetes: Timely Insulin Initiation and Titration
Status:
COMPLETED
Status Verified Date:
2014-07
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:
AFICIONADO
Brief Summary:
Primary Objective:
Percentage of patients achieving Glycosylated Hemoglobin (HbA1c) \< 7% with no severe or nocturnal hypoglycemic episodes at 6 months
Secondary Objectives:
* Glycosylated Hemoglobin (HbA1c) change from baseline to 6 months
* Insulin glargine dose at 3 and 6 months
* Hypoglycemic episodes (all types)
Percentage of patients achieving Glycosylated Hemoglobin (HbA1c) \< 7% with no severe or nocturnal hypoglycemic episodes at 6 months
Secondary Objectives:
* Glycosylated Hemoglobin (HbA1c) change from baseline to 6 months
* Insulin glargine dose at 3 and 6 months
* Hypoglycemic episodes (all types)
Detailed Description:
None
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 |
|---|---|---|---|---|
| U1111-1116-9268 | OTHER | UTN | View |