Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2026-01-17 @ 11:51 AM
Study NCT ID:
NCT02606357
Status:
COMPLETED
Last Update Posted:
2018-10-12
First Post:
2015-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Type 2 Diabetes With Long Acting Basal Insulin in Jordan
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
Treatment Initiation With Basal Insulin in Uncontrolled Type 2 Diabetes Patients on Oral Anti-Diabetic Agent (OAD) in Jordan
Status:
COMPLETED
Status Verified Date:
2018-10
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:
NEWLAN
Brief Summary:
Primary Objective:
-To assess the change in glycosylated hemoglobin (HbA1c) in uncontrolled Type 2 diabetes patients on OAD agent in Jordan after 6 months of treatment with basal insulin (Insulin glargine).
Secondary Objectives:
* To evaluate the percentage of patients achieving target of HbA1c ˂7%.
* To evaluate the change in fasting plasma glucose (FPG).
* To assess the following safety criteria: hypoglycemic events, body weight changes, and overall safety.
* Describe the titration process: changes in glargine insulin dose at 3 months and 6 months, changes in the titration doses used (if any), and time to reach control.
-To assess the change in glycosylated hemoglobin (HbA1c) in uncontrolled Type 2 diabetes patients on OAD agent in Jordan after 6 months of treatment with basal insulin (Insulin glargine).
Secondary Objectives:
* To evaluate the percentage of patients achieving target of HbA1c ˂7%.
* To evaluate the change in fasting plasma glucose (FPG).
* To assess the following safety criteria: hypoglycemic events, body weight changes, and overall safety.
* Describe the titration process: changes in glargine insulin dose at 3 months and 6 months, changes in the titration doses used (if any), and time to reach control.
Detailed Description:
The total duration of study period per patient is up to 6 months.
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 |
|---|---|---|---|---|
| U1111-1172-1002 | OTHER | UTN | View |