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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:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01486381
First received: November 22, 2011
Last updated: December 2, 2011
Last verified: December 2011
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 22
Study Start Date: March 2002
Study Completion Date: May 2003
Primary Completion Date: May 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)

  Eligibility

Ages Eligible for Study:   10 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01486381

Locations
South Africa
Pretoria, Gauteng, South Africa, 0001
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Henning Andersen Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01486381     History of Changes
Other Study ID Numbers: BIASP-1459
Study First Received: November 22, 2011
Last Updated: December 2, 2011
Health Authority: South Africa: Medicines Control Council

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
 Insulin aspart
Insulin
Insulin, NPH
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013