Insulin Glargine in Type 1 Diabetes Mellitus
The primary purpose of the protocol is to demonstrate that the new regimen (insulin glargine+regular insulin ) is no worse than the reference regimen (insulin glargine+lys-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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Italian Experience Trial for the Implementation of the Use of Lantus in Basal - Bolus Regimen in Type I Diabetes Mellitus Patients.|
- severe nocturnal hypoglycemias will be measured throughout the study period.
- HbA1c will be measured at basal and 8/16 weeks after start of treatment
- 8 point glucose profile will be measured during last 2 weeks before each scheduled visit
- severe hypoglycemias and nocturnal hypoglycemias will be measured throughout the study period.
|Study Start Date:||November 2002|
|Study Completion Date:||December 2005|
|Primary Completion Date:||December 2005 (Final data collection date for primary outcome measure)|