Insulin Glargine in Type 1 Diabetes Mellitus

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 1

• Registration Number: NCT00272090
• Lead Sponsor: Sanofi

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-11
• Primary Completion: 2005-12
• Study Completion: 2005-12
• Study First Submitted: 2006-01-02
• Study First Submitted QC: 2006-01-02
• Study First Posted: 2006-01-04
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-07
• Last Update Posted: 2011-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 489

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
severe nocturnal hypoglycemias will be measured throughout the study period.

Secondary Outcome Measures

Name	Time	Method
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.