Status:
COMPLETED
Apidra Children & Adolescents Study
Lead Sponsor:
Sanofi
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
6-17 years
Phase:
PHASE4
Brief Summary
Primary Objective: Evaluate the percentage of patients achieving glycosylated hemoglobin (HbA1c) level \< 8% (in patients of 6-12 years old) and HbA1c level \< 7.5% (in patients of 13-17 year old) at...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- ChildrenAdolescents with Type 1 diabetes Mellitus l(T1DM) onger than 1 year duration
- Age 6 -17 y.o.
- With 8%\<HbA1c \<10%
- Treated with insulin glargine and any rapid insulin
- Ability to perform a self blood-glucose monitoring (SBGM)
- Signed Informed consent.
- Exclusion criteria:
- Diabetes Mellitus type 2
- ChildrenAdolescents with Type 1 diabetes Mellitus previously treated with Apidra
- Hypersensitivity to Insulin glulisine
- Pregnant or lactation women
- Gestational diabetes mellitus
- Treatment with systemic corticosteroids in the 1 month prior to study entry
- T1DM complications: such as already existing active proliferative diabetic retinopathy, as defined by the application of photocoagulation or surgery, in the 6 months before study entry or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgery during the study.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01202474
Start Date
May 1 2011
End Date
October 1 2012
Last Update
December 18 2012
Active Locations (1)
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1
Administrative office
Moscow, Russia