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Apidra Children & Adolescents Study

NCT01202474 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2012-12-18

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DRUG

INSULIN GLULISINE

Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: once a day

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • Russia

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01202474 on ClinicalTrials.gov