Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00272090
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2006-01-02
Brief Title:
Insulin Glargine in Type 1 Diabetes Mellitus
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Italian Experience Trial for the Implementation of the Use of Lantus in Basal - Bolus Regimen in Type I Diabetes Mellitus Patients
Status:
COMPLETED
Status Verified Date:
2011-06
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 purpose of the protocol is to demonstrate that the new regimen insulin glargineregular insulin is no worse than the reference regimen insulin glarginelys-pro insulin in reducing the incidence of severe nocturnal hypoglycemia at the end point the secondary purpose is to compare the two study regimens as far as the glycemic control measured by HbA1c the daily Mean Blood Glucose MBG and the mean amplitude of glycemic excursion MAGE index calculated on the basis of Self Monitoring Blood Glugose SMBG data are concerned and to verify the safety of basal insulinization with Lantus
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