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

A Multi-national, Multi-centre, Open-labelled Extension Study Assessing the Long-term Safety of Biphasic Insulin Aspart 30 (BIAsp 30) in Young Diabetic Subjects With Type 1 Diabetes Mellitus Previously Treated in BIAsp-1240

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01486381

Enrollment

Registered

2011-12-06

Start date

2002-03-20

Completion date

2003-05-30

Last updated

2017-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 1

Brief summary

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.

Interventions

DRUGbiphasic insulin aspart 30

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

10 Years to 17 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Number of hypoglycaemic episodes	—
Occurence of adverse events	—
Standard safety parameters: Haematology, biochemistry and vital signs	—

Secondary

Measure	Time frame
HbA1c (glycosylated haemoglobin)	—
Blood glucose level at each time-point in the 8-point glucose profile	—
BMI (Body Mass Index)	—

Countries

South Africa

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026