Comparison of NPH Insulin and Insulin Detemir 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

NCT00435019

NN304-1689

2006-000051-18 (EudraCT Number)

Details and patient eligibility

About

This trial is conducted in Europe.

The aim of this research is to compare the efficacy and safety of treatment with NPH insulin and insulin detemir. You will be treated with either insulin detemir or NPH insulin once or twice daily as basal insulin. Additionally you will receive insulin aspart as bolus insulin

Enrollment: 348 patients

Sex: All

Ages: 2 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Insulin detemir naive
• Type 1 diabetes for at least 12 months
• HbA1c lesser than or equal to 11.0%

Exclusion criteria

• Significant concomitant diseases

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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348 participants in 2 patient groups

insulin detemir

Experimental group

Description:

insulin detemir + insulin aspart

Treatment:

Drug: insulin detemir

Drug: insulin aspart

NPH insulin

Experimental group

Description:

NPH insulin + insulin aspart

Treatment:

Drug: insulin NPH

Drug: insulin aspart