Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00272064
Status:
COMPLETED
Last Update Posted:
2009-12-07
First Post:
2006-01-02
Brief Title:
ELEONOR STUDY Insulin Glulisine in Type 2 Diabetes Mellitus
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Optimisation of Insulin Treatment of Type 2 Diabetes Mellitus by Telecare Assistance for Self Monitoring of Blood Glucose SMBG
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:
None
Brief Summary:
The primary objective of the present study is to verify the superiority of Telecare program vs standard SMBG program in terms of mean HbA1c value - 05 at end-point
The secondary objectives of the study are the assessment of total daily dose of insulin changes in glycaemic and lipid profile frequency of hypoglycaemias changes in weight health-related quality of life cost-effectiveness of Telecare program vs common ambulatory program general safety adverse event profile other routine laboratory parameters
The secondary objectives of the study are the assessment of total daily dose of insulin changes in glycaemic and lipid profile frequency of hypoglycaemias changes in weight health-related quality of life cost-effectiveness of Telecare program vs common ambulatory program general safety adverse event profile other routine laboratory parameters
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 2004-002731-62 | None | None | None |