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

Novo Nordisk

Status and phase

Completed

Phase 3

Conditions

Diabetes Mellitus, Type 1

Diabetes

Treatments

Drug: insulin aspart

Drug: insulin NPH

Drug: insulin detemir

Study type

Interventional

Funder types

Industry

Identifiers

NCT00312156

NN304-1379

Details and patient eligibility

About

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.

Enrollment

347 patients

Sex

All

Ages

6 to 17 years old

Volunteers

No Healthy Volunteers

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/m2.
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