Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
100 participants
INTERVENTIONAL
2011-05-31
2012-10-31
Brief Summary
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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 6 and 12 months of treatment
Secondary Objectives:
Change in HbA1c level at 6 and 12 months of treatment Monthly rate of hypoglycaemia/per patient from the baseline to the end of the study Change in daily dose of glargine and glulisine at 6 and 12 months of treatment.
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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insulin glulisine and insulin glargine
insulin glulisine and insulin glargine basal/bolus regimen in accordance with the summary of product characteristics and titrated to Plasma glucose target as defined by American Diabetes Association (ADA) recommendations age-specific goals (12)
INSULIN GLULISINE
Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: once a day
INSULIN GLARGINE
Pharmaceutical form:solution for injection Route of administration: subcutaneous Dose regimen: 0-15 minutes before meal or within 20 minutes from the start of meal according to prandial plasma glucose values
Interventions
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INSULIN GLULISINE
Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: once a day
INSULIN GLARGINE
Pharmaceutical form:solution for injection Route of administration: subcutaneous Dose regimen: 0-15 minutes before meal or within 20 minutes from the start of meal according to prandial plasma glucose values
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
6 Years
17 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Administrative office
Moscow, , Russia
Countries
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Other Identifiers
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U1111-1116-8645
Identifier Type: OTHER
Identifier Source: secondary_id
APIDR_L_04884
Identifier Type: -
Identifier Source: org_study_id