Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2025-12-24 @ 3:54 PM
Study NCT ID:
NCT02954692
Status:
COMPLETED
Last Update Posted:
2019-01-14
First Post:
2016-11-02
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Effectiveness and Safety Initiation and Titration of Insulin Glargine (U300) in Insulin-naïve Patients With Type 2 Diabetes Mellitus (T2DM) Controlled on Oral Antidiabetic Drug Treatment in Turkey
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
A National, Multicenter, Prospective, Interventional, Open-label, Single-arm, 24-Week Phase IV Study to Evaluate the Effectiveness and Safety of Initiation and Titration of Insulin Glargine U300 in Insulin-naïve Patients With T2DM Inadequately Controlled on OAD Treatment in Turkey
Status:
COMPLETED
Status Verified Date:
2019-01
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:
EASE
Brief Summary:
Primary Objective:
To assess the mean change in HbA1c (glycated haemoglobin).
Secondary Objectives:
To evaluate the efficacy and safety of the titration of insulin glargine U300 in terms of:
* Targeted HbA1c;
* Targeted fasting self- monitoring blood glucose (SMBG);
* Hypoglycemic events;
* Adverse events;
* Quality of life assessment by DTSQs (Diabetes Treatment Satisfaction Questionnaire status) and DTSQc (Diabetes Treatment Satisfaction Questionnaire change);
* Blood glucose fluctuation by using continuous glucose monitoring system (CGMS) in subgroup patients.
To assess the mean change in HbA1c (glycated haemoglobin).
Secondary Objectives:
To evaluate the efficacy and safety of the titration of insulin glargine U300 in terms of:
* Targeted HbA1c;
* Targeted fasting self- monitoring blood glucose (SMBG);
* Hypoglycemic events;
* Adverse events;
* Quality of life assessment by DTSQs (Diabetes Treatment Satisfaction Questionnaire status) and DTSQc (Diabetes Treatment Satisfaction Questionnaire change);
* Blood glucose fluctuation by using continuous glucose monitoring system (CGMS) in subgroup patients.
Detailed Description:
The total study duration per patient will be 27 weeks (2 weeks of screening, 24 weeks on treatment, and 1 week 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 |
|---|---|---|---|---|
| U1111-1183-8755 | OTHER | UTN | View |