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

This study has been completed.
Information provided by (Responsible Party):
Novo Nordisk A/S Identifier:
First received: November 22, 2011
Last updated: February 22, 2017
Last verified: February 2017
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.

Condition Intervention Phase
Diabetes Diabetes Mellitus, Type 1 Drug: biphasic insulin aspart 30 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Number of hypoglycaemic episodes
  • Occurence of adverse events
  • Standard safety parameters: Haematology, biochemistry and vital signs

Secondary Outcome Measures:
  • HbA1c (glycosylated haemoglobin)
  • Blood glucose level at each time-point in the 8-point glucose profile
  • BMI (Body Mass Index)

Enrollment: 22
Actual Study Start Date: March 20, 2002
Study Completion Date: May 30, 2003
Primary Completion Date: May 30, 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BIAsp 30 Drug: biphasic insulin aspart 30
Administered subcutaneously (s.c., under the skin)


Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01486381

South Africa
Novo Nordisk Investigational Site
Pretoria, Gauteng, South Africa, 0001
Novo Nordisk Investigational Site
Cape Town, Western Cape, South Africa, 7925
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S Identifier: NCT01486381     History of Changes
Other Study ID Numbers: BIASP-1459
Study First Received: November 22, 2011
Last Updated: February 22, 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin Aspart
Insulin, Long-Acting
Biphasic Insulins
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on September 21, 2017