Apidra Children & Adolescents Study

Phase 4CompletedNCT01202474

Sanofi100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Diabetes Mellitus, Type 1

Interventions

INSULIN GLULISINEDRUG

Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: once a day

INSULIN GLARGINEDRUG

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

Eligibility

Sex: ALLMin age: 6 YearsMax age: 17 Years

Medical Language ↔ Plain English

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.

Locations (1)

Administrative office

Moscow, Russia

Outcomes

Primary Outcomes

Percentage of patients achieving HbA1c level < 8% (in patients 6-12 year-old) and HbA1c level < 7.5 % (in patients 13-17 year-old)

Time frame: at 6 and 12 months of treatment

Secondary Outcomes

Change in HbA1c plasma level

Time frame: at 6 and 12 months of treatment

Monthly rate of hypoglycaemia

Time frame: from baseline to 12 months of treatment (study cut off)

Change in daily dose of glargine and glulisine

Time frame: at 6 and 12 months of treatment

Data from ClinicalTrials.gov

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