Apidra Children & Adolescents Study

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Insulin; Insulin Glargine; Insulin glulisine; Insulin, Globin Zinc

Criteria

Inclusion criteria:

• ChildrenAdolescents with Type 1 diabetes Mellitus l(T1DM) onger 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.

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.