Diabetes Mellitus, Type 1
Conditions
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 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.
Interventions
DRUGINSULIN GLULISINE
Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: once a day
DRUGINSULIN 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
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients achieving HbA1c level < 8% (in patients 6-12 year-old) and HbA1c level < 7.5 % (in patients 13-17 year-old) | at 6 and 12 months of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Change in HbA1c plasma level | at 6 and 12 months of treatment |
| Monthly rate of hypoglycaemia | from baseline to 12 months of treatment (study cut off) |
| Change in daily dose of glargine and glulisine | at 6 and 12 months of treatment |
Countries
Russia
Outcome results
None listed