Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00518427
Status:
COMPLETED
Last Update Posted:
2009-12-07
First Post:
2007-08-17
Brief Title:
Evaluate Quality of Life in Type 2 Diabetes Before and After Change to Insuline Glargine
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Multicenter Clinical Trial to Evaluate Quality of Life in Patients With Type 2 Diabetes Before and After Changing Therapy to a Combination of Insulin Glargine and Oral Antidiabetic Drugs in a Real Life Situation
Status:
COMPLETED
Status Verified Date:
2009-12
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:
QoL
Brief Summary:
Primary objective
To assess quality of Life QoL changes and treatment satisfaction in a real life situation in patients with Type 2 diabetes inadequately controlled on a combination of oral antidiabetic drugs OAD plus Neutral Protamine Hagedrone NHP insulin treatment that are switched to insulin glargine
Secondary objective
To determine
change in HbA1c comparision of the incidence of symptomatic hypoglycemia and severe hypoglycemia before and after introduction of insulin glargine change in weight change in insulin dose
To assess quality of Life QoL changes and treatment satisfaction in a real life situation in patients with Type 2 diabetes inadequately controlled on a combination of oral antidiabetic drugs OAD plus Neutral Protamine Hagedrone NHP insulin treatment that are switched to insulin glargine
Secondary objective
To determine
change in HbA1c comparision of the incidence of symptomatic hypoglycemia and severe hypoglycemia before and after introduction of insulin glargine change in weight change in insulin dose
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Eudract 2005-000959-15 | None | None | None |