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Apidra Children & Adolescents Study

Primary Purpose

Diabetes Mellitus, Type 1

Status
Completed
Phase
Phase 4
Locations
Russian Federation
Study Type
Interventional
Intervention
INSULIN GLULISINE
INSULIN GLARGINE
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Administrative office

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

insulin glulisine and insulin glargine

Arm Description

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)

Outcomes

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)

Secondary Outcome Measures

Change in HbA1c plasma level
Monthly rate of hypoglycaemia
Change in daily dose of glargine and glulisine

Full Information

First Posted
September 14, 2010
Last Updated
December 17, 2012
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT01202474
Brief Title
Apidra Children & Adolescents Study
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.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
insulin glulisine and insulin glargine
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
INSULIN GLULISINE
Other Intervention Name(s)
Apidra
Intervention Description
Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: once a day
Intervention Type
Drug
Intervention Name(s)
INSULIN GLARGINE
Other Intervention Name(s)
Lantus
Intervention Description
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
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Change in HbA1c plasma level
Time Frame
at 6 and 12 months of treatment
Title
Monthly rate of hypoglycaemia
Time Frame
from baseline to 12 months of treatment (study cut off)
Title
Change in daily dose of glargine and glulisine
Time Frame
at 6 and 12 months of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Administrative office
City
Moscow
Country
Russian Federation

12. IPD Sharing Statement

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Apidra Children & Adolescents Study

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