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Completed

NCT Number: NCT01202474

Apidra Children & Adolescents Study

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Administrative office

Moscow, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

insulin glulisine

Drug

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

Other names: Apidra

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

Other names: Lantus

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)

    Time frame: at 6 and 12 months of treatment

Secondary outcomes

  1. Change in HbA1c plasma level

    Time frame: at 6 and 12 months of treatment

  2. Monthly rate of hypoglycaemia

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

  3. Change in daily dose of glargine and glulisine

    Time frame: at 6 and 12 months of treatment

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

A Study of Effectiveness and Safety of Apidra in Combination With Lantus Therapy in Basal-bolus Insulin Regimen in Inadequately Controlled Children and Adolescents With Type 1 Diabetes in the Russian Federation.

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 15, 2010
Registry last updated
Dec 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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