Insulin Glargine in Type 1 Diabetes Mellitus
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|ClinicalTrials.gov Identifier: NCT00272090|
Recruitment Status : Completed
First Posted : January 4, 2006
Last Update Posted : June 8, 2011
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 1||Drug: Insulin glargine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||489 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Italian Experience Trial for the Implementation of the Use of Lantus in Basal - Bolus Regimen in Type I Diabetes Mellitus Patients.|
|Study Start Date :||November 2002|
|Actual Primary Completion Date :||December 2005|
|Actual Study Completion Date :||December 2005|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00272090
|Study Director:||PAIZIS GEORGES, MD||Sanofi|