Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2026-03-01 @ 9:55 PM
Study NCT ID:
NCT00941369
Status:
COMPLETED
Last Update Posted:
2012-11-22
First Post:
2009-07-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Health Assessment, Patient Treatment Satisfaction and Quality-of-Life in Insulin-Naive Type 2 Diabetes Patients
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
Health Assessment, Patient Treatment Satisfaction and Quality-of-Life in Insulin-naive Type 2 Diabetes Patients Uncontrolled on Oral Hypoglycemic Agent Treatment Initiating Basal Insulin Therapy With Either Insulin Glargine or NPH Insulin
Status:
COMPLETED
Status Verified Date:
2012-11
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 investigate the impact of insulin glargine versus Neutral Protamine Hagedorn basal insulin on a composite diabetes related quality of life score (DRQoL).
Secondary Objective:
A comparison of combination therapy with insulin glargine versus Neutral Protamine Hagedorn basal insulin from baseline to endpoint in terms of:
* Glycaemic parameters: 7 blood glucose profiles
* Incidence of confirmed symptomatic hypoglycemia as well as confirmed severe hypoglycemia
* Change in lipid status
To investigate the impact of insulin glargine versus Neutral Protamine Hagedorn basal insulin on a composite diabetes related quality of life score (DRQoL).
Secondary Objective:
A comparison of combination therapy with insulin glargine versus Neutral Protamine Hagedorn basal insulin from baseline to endpoint in terms of:
* Glycaemic parameters: 7 blood glucose profiles
* Incidence of confirmed symptomatic hypoglycemia as well as confirmed severe hypoglycemia
* Change in lipid status
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2009-019013-59(EudraCT) | None | None | View |