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

Novo Nordisk A/S347 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

347

Conditions

Diabetes Diabetes Mellitus, Type 1

Interventions

insulin detemirDRUG

insulin NPHDRUG

insulin aspartDRUG

Eligibility

Sex: ALLMin age: 6 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (42)

Outcomes

Primary Outcomes

HbA1c

Time frame: after 26 weeks

Secondary Outcomes

Adverse events

body weight

Antibodies

Blood glucose

Hypoglycaemia

Data from ClinicalTrials.gov

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