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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01486381
First received: November 22, 2011
Last updated: February 22, 2017
Last verified: February 2017
November 22, 2011
February 22, 2017
March 20, 2002
May 30, 2003   (Final data collection date for primary outcome measure)
  • Number of hypoglycaemic episodes
  • Occurence of adverse events
  • Standard safety parameters: Haematology, biochemistry and vital signs
Same as current
Complete list of historical versions of study NCT01486381 on ClinicalTrials.gov Archive Site
  • HbA1c (glycosylated haemoglobin)
  • Blood glucose level at each time-point in the 8-point glucose profile
  • BMI (Body Mass Index)
Same as current
Not Provided
Not Provided
 
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
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.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 1
Drug: biphasic insulin aspart 30
Administered subcutaneously (s.c., under the skin)
Experimental: BIAsp 30
Intervention: Drug: biphasic insulin aspart 30
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
May 30, 2003
May 30, 2003   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
10 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
South Africa
 
 
NCT01486381
BIASP-1459
No
Not Provided
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
February 2017

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