Apidra Children & Adolescents Study

Study Overview
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Brief Summary
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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.

Official Title
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A Study of Effectiveness and Safety of Apidra in Combination With Lantus Therapy in Basal-bolus Insulin Regimen in Inadequately Controlled Children and Adolescents With Type 1 Diabetes in the Russian Federation.

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Drug: INSULIN GLULISINE
* Drug: INSULIN GLARGINE


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: insulin glulisine and insulin glargine<br>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) | Drug: INSULIN GLULISINE<br>* Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: once a day<br>* Other names: Apidra;Drug: INSULIN GLARGINE<br>* 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<br>* Other names: Lantus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 |