Comparison of Efficacy and Safety of Insulin Detemir and NPH Insulin in Children and Adolescents With Type 1 Diabetes

Novo Nordisk A/S1 site in 1 country347 target enrollmentAugust 2002

ConditionsDiabetes Diabetes Mellitus, Type 1

Drugsinsulin detemir insulin NPH insulin aspart

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Diabetes
Sponsor: Novo Nordisk A/S
Enrollment: 347
Locations: 1
Primary Endpoint: HbA1c
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The trial is conducted in Europe and Middle East. The aim of the trial is to compare the use of Insulin Detemir once or twice daily combined with mealtime Insulin Aspart against that of NPH Insulin once or twice daily combined with mealtime Insulin Aspart. The trial involves children and adolescents with Type 1 Diabetes.

Registry

clinicaltrials.gov

Start Date

August 2002

End Date

August 2003

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novo Nordisk A/S

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Type 1 diabetes for at least 12 months
•Informed consent obtained
•BMI: 6-7 years: less than or equal to 19 kg/m2, 8-9 years: less than or equal to 20 kg/m2, 10-11 years: less than or equal to 22 kg/m2, 12-13 years: less than or equal to 24 kg/m2 and 14-17 years: less than or equal to 27 kg/m
•HbA1c equal to or less than 12.0%

Exclusion Criteria

•Proliferate retinopathy or maculopathy
•Total daily insulin dose greater than 2.00 IU/kg
•Any condition or disease that rule out trial participation according to the judgement of the investigator.
•Mental incapacity, unwillingness or language barriers precluding understanding or cooperation.
•A life-style incompatible with trial participation