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

This study has been completed.

Sponsor:

Information provided by:

Novo Nordisk

ClinicalTrials.gov Identifier:

NCT01486381

First received: November 22, 2011

Last updated: December 2, 2011

Last verified: December 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

November 22, 2011

Last Updated Date

December 2, 2011

Start Date ^ICMJE

March 2002

Primary Completion Date

May 2003 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Number of hypoglycaemic episodes [ Designated as safety issue: No ]
Occurence of adverse events [ Designated as safety issue: No ]
Standard safety parameters: Haematology, biochemistry and vital signs [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01486381 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

HbA1c (glycosylated haemoglobin) [ Designated as safety issue: No ]
Blood glucose level at each time-point in the 8-point glucose profile [ Designated as safety issue: No ]
BMI (Body Mass Index) [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Diabetes
Diabetes Mellitus, Type 1

Intervention ^ICMJE

Drug: biphasic insulin aspart 30

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

Study Arm (s)

Experimental: BIAsp 30

Intervention: Drug: biphasic insulin aspart 30

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2003

Primary Completion Date

May 2003 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

10 Years to 17 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

South Africa

Administrative Information

NCT Number ^ICMJE

NCT01486381

Other Study ID Numbers ^ICMJE

BIASP-1459

Has Data Monitoring Committee

Responsible Party

Public Access to Clinical Trials, Novo Nordisk A/S

Study Sponsor ^ICMJE

Novo Nordisk

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Henning Andersen

Novo Nordisk

Information Provided By

Novo Nordisk

Verification Date

December 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top