Apidra Children & Adolescents Study - Full Text View

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:

Genetics Home Reference related topics: type 1 diabetes

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 1 Hypoglycemia

Drug Information available for: Insulin human Insulin glargine Insulin glulisine

U.S. FDA Resources

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

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

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

Glargine
Insulin glulisine
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013