Back to resultsLong Term Safety of Biphasic Insulin Aspart 30 in Juveniles With Type 1 Diabetes
Primary Purpose
Diabetes, Diabetes Mellitus, Type 1
Status
Completed
Phase
Phase 3
Locations
South Africa
Study Type
Interventional
Intervention
biphasic insulin aspart 30
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
Eligibility 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
Sites / Locations
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BIAsp 30
Arm Description
Outcomes
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01486381
Brief Title
Long Term Safety of Biphasic Insulin Aspart 30 in Juveniles With Type 1 Diabetes
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
March 20, 2002 (Actual)
Primary Completion Date
May 30, 2003 (Actual)
Study Completion Date
May 30, 2003 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 1
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BIAsp 30
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
biphasic insulin aspart 30
Intervention Description
Administered subcutaneously (s.c., under the skin)
Primary Outcome Measure Information:
Title
Number of hypoglycaemic episodes
Title
Occurence of adverse events
Title
Standard safety parameters: Haematology, biochemistry and vital signs
Secondary Outcome Measure Information:
Title
HbA1c (glycosylated haemoglobin)
Title
Blood glucose level at each time-point in the 8-point glucose profile
Title
BMI (Body Mass Index)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0001
Country
South Africa
Facility Name
Novo Nordisk Investigational Site
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7925
Country
South Africa
12. IPD Sharing Statement
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Long Term Safety of Biphasic Insulin Aspart 30 in Juveniles With Type 1 Diabetes
We'll reach out to this number within 24 hrs