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
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 1
Drug: INSULIN GLULISINE
Drug: INSULIN GLARGINE
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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.

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 100
Study Start Date: May 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
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

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01202474

Locations
Russian Federation
Administrative office
Moscow, Russian Federation
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01202474     History of Changes
Other Study ID Numbers: APIDR_L_04884, U1111-1116-8645
Study First Received: September 14, 2010
Last Updated: December 17, 2012
Health Authority: Russia: Ministry of Health of the Russian Federation

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin glulisine
Glargine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014