Apidra Children & Adolescents Study

Sanofi

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 1

Treatments: Drug: INSULIN GLARGINE; Drug: INSULIN GLULISINE

Study type: Interventional

Funder types: Industry

Identifiers

NCT01202474

APIDR_L_04884

U1111-1116-8645 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

insulin glulisine and insulin glargine

Experimental group

Description:

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)

Treatment:

Drug: INSULIN GLULISINE

Drug: INSULIN GLARGINE