Apidra Children & Adolescents Study

NCT01202474 | Completed Phase 4

• 2 other identifiers: APIDR_L_04884U1111-1116-8645
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (1)

insulin glulisine and insulin glargine

EXPERIMENTAL

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; Drug: INSULIN GLARGINE

Interventions

INSULIN GLULISINE DRUG

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

Also known as: Apidra

insulin glulisine and insulin glargine

INSULIN GLARGINE DRUG

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

Also known as: Lantus

insulin glulisine and insulin glargine

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Administrative office

Moscow, Russia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

insulin glulisine; Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2010
• First Posted: September 15, 2010
• Study Start: May 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: December 18, 2012

Record last verified: 2012-12

Locations

RU (1)