Apidra Children & Adolescents Study

Conditions: Diabetes Mellitus, Type 1
MedDRA version: 17.1Level: PTClassification code 10067584Term: Type 1 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2014-004639-38-Outside-EU/EEA

Lead Sponsor: Sanofi

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 100

Inclusion Criteria

ChildrenAdolescents with Type 1 diabetes Mellitus (T1DM) longer than 1 year duration
Age 6 -17 y.o.
With 8%Treated with insulin glargine and any rapid insulin
Ability to perform a self blood-glucose monitoring (SBGM)
Signed Informed consent.
Are the trial subjects under 18? yes
Number of subjects for this age range: 100
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main 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 Objective: To evaluate the change in HbA1c level at 6 and 12 months of treatment <br>To evaluate monthly rate of hypoglycaemia/per patient from the baseline to the end of the study <br>To evaluate the change in daily dose of glargine and glulisine at 6 and 12 months of treatment;Primary end point(s): 1. % of patients who achieved HbA1c level < 8% in subjects 6-12 years old<br>2. % of patients who achieved HbA1c level < 7.5% in subjects 13 - 17 years old;Timepoint(s) of evaluation of this end point: at 6 and 12 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. change in HbA1C<br>2. change in daily dose of insuline glargine and glulisine<br>3. rate of hypoglycemia per patient ;Timepoint(s) of evaluation of this end point: 1. BL, 6,12 months<br>2. BL, 6,12 months<br>3. From BL up to 12 months