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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01486381
• Other study ID #: BIASP-1459
• Status: Completed
• Phase: Phase 3
• First received: November 22, 2011
• Last updated: February 22, 2017
• Start date: March 20, 2002
• Est. completion date: May 30, 2003

Study information

• Verified date: February 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: May 30, 2003
• Est. primary completion date: May 30, 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• biphasic insulin aspart 30
Administered subcutaneously (s.c., under the skin)

Locations

Country	Name	City	State
South Africa	Novo Nordisk Investigational Site	Cape Town	Western Cape
South Africa	Novo Nordisk Investigational Site	Pretoria	Gauteng

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of hypoglycaemic episodes
Primary	Occurence of adverse events
Primary	Standard safety parameters: Haematology, biochemistry and vital signs
Secondary	HbA1c (glycosylated haemoglobin)
Secondary	Blood glucose level at each time-point in the 8-point glucose profile
Secondary	BMI (Body Mass Index)

External Links

•   Clinical Trials at Novo Nordisk