Apidra Children & Adolescents Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01202474
First received: September 14, 2010
Last updated: December 17, 2012
Last verified: December 2012

September 14, 2010
December 17, 2012
May 2011
October 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01202474 on ClinicalTrials.gov Archive Site
  • Change in HbA1c plasma level [ Time Frame: at 6 and 12 months of treatment ] [ Designated as safety issue: No ]
  • Monthly rate of hypoglycaemia [ Time Frame: from baseline to 12 months of treatment (study cut off) ] [ Designated as safety issue: Yes ]
  • Change in daily dose of glargine and glulisine [ Time Frame: at 6 and 12 months of treatment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Apidra Children & Adolescents Study
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.

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 1
  • Drug: INSULIN GLULISINE
    Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: once a day
    Other Name: Apidra
  • Drug: INSULIN GLARGINE
    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 Name: Lantus
Experimental: insulin glulisine and insulin glargine
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)
Interventions:
  • Drug: INSULIN GLULISINE
  • Drug: INSULIN GLARGINE
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
October 2012
October 2012   (final data collection date for primary outcome measure)

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.

Both
6 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation
 
NCT01202474
APIDR_L_04884, U1111-1116-8645
Not Provided
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP