Apidra Children & Adolescents Study

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Drug: INSULIN GLULISINE; Drug: INSULIN GLARGINE

• Registration Number: NCT01202474
• Lead Sponsor: Sanofi

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-14
• Study First Submitted QC: 2010-09-14
• Study First Posted: 2010-09-15
• Study Start: 2011-05
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-17
• Last Update Posted: 2012-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
insulin glulisine and insulin glargine	INSULIN GLULISINE	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)
insulin glulisine and insulin glargine	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)

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Change in HbA1c plasma level	at 6 and 12 months of treatment
Monthly rate of hypoglycaemia	from baseline to 12 months of treatment (study cut off)
Change in daily dose of glargine and glulisine	at 6 and 12 months of treatment

Trial Locations

Locations (1)

Administrative office; 🇷🇺 Moscow, Russian Federation