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

Novo Nordisk A/S348 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

348

Conditions

Diabetes Diabetes Mellitus, Type 1

Interventions

insulin detemirDRUG

s.c. injection, once or twice daily.

insulin NPHDRUG

s.c. injection, once or twice daily.

insulin aspartDRUG

s.c. injection, at main meals.

Eligibility

Sex: ALLMin age: 2 YearsMax age: 16 Years

Medical Language ↔ Plain English

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

Locations (43)

Outcomes

Primary Outcomes

Glycosylated Haemoglobin A1c (HbA1c)

Glycosylated haemoglobin A1c (HbA1c) measured after 52 weeks of treatment and analysed by central laboratory.

Time frame: after 52 weeks of treatment

Secondary Outcomes

Number of Subjects Reporting Adverse Events

Number of subjects reporting adverse events during the trial (from week -2 to week 52). For details, please refer to the adverse events section.

Time frame: from week -2 to week 52

Observed Insulin Antibody Values

Observed insulin antibody values for insulin detemir specific antibodies, insulin aspart specific antibodies and insulin detemir/insulin aspart cross-reacting antibodies.

Time frame: at 0 and 52 weeks

Data from ClinicalTrials.gov

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