Apidra Children & Adolescents Study

Diabetes Mellitus, Type 1 Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01202474
• Other study ID #: APIDR_L_04884
• Secondary ID: U1111-1116-8645
• Status: Completed
• Phase: Phase 4
• First received: September 14, 2010
• Last updated: December 17, 2012
• Start date: May 2011
• Est. completion date: October 2012

Study information

• Verified date: December 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 17 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1

Intervention

Drug:
• INSULIN GLULISINE
Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: once a day
• 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

Locations

Country	Name	City	State
Russian Federation	Administrative office	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients achieving HbA1c level < 8% (in patients 6-12 year-old) and HbA1c level < 7.5 % (in patients 13-17 year-old)		at 6 and 12 months of treatment	No
Secondary	Change in HbA1c plasma level		at 6 and 12 months of treatment	No
Secondary	Monthly rate of hypoglycaemia		from baseline to 12 months of treatment (study cut off)	Yes
Secondary	Change in daily dose of glargine and glulisine		at 6 and 12 months of treatment	No