Long Term Safety of Biphasic Insulin Aspart 30 in Juveniles With Type 1 Diabetes

Novo Nordisk A/S22 enrolled

Overview

This trial is conducted in South Africa. The aim of this trial is to investigate Long term safety of biphasic insulin aspart 30 in juveniles with type 1 diabetes previously treated in trial BIAsp-1240.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes Diabetes Mellitus, Type 1

Interventions

biphasic insulin aspart 30DRUG

Administered subcutaneously (s.c., under the skin)

Eligibility

Sex: ALLMin age: 10 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Signed informed consent obtained before any trial-related activities according to local requirements. (Trial-related activities are any procedure that would not have been performed during normal management of the subject) * The subject must have completed the trial BIAsp-1240

Locations (2)

Novo Nordisk Investigational Site

Pretoria, Gauteng, South Africa

Novo Nordisk Investigational Site

Cape Town, Western Cape, South Africa

Outcomes

Primary Outcomes

Number of hypoglycaemic episodes

Occurence of adverse events

Standard safety parameters: Haematology, biochemistry and vital signs

Secondary Outcomes

HbA1c (glycosylated haemoglobin)

Blood glucose level at each time-point in the 8-point glucose profile

BMI (Body Mass Index)

Data from ClinicalTrials.gov

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