Back to resultsLong Term Safety and Efficacy of Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes
Primary Purpose
Diabetes, Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 3
Locations
Canada
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:
- Completed the BIAsp-1237 trial
Sites / Locations
- Novo Nordisk Investigational Site
- Novo Nordisk Investigational Site
- 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
HbA1c
Secondary Outcome Measures
Occurrence of adverse events
Occurence of hypoglycaemic episodes
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01527539
Brief Title
Long Term Safety and Efficacy of Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes
Official Title
A Multi-centre, Non-comparative, Open-labelled, Extension Trial to Assess the Long Term Safety and Efficacy of Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes (Extension to BIAsp-1237)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
November 23, 2001 (Actual)
Primary Completion Date
October 12, 2004 (Actual)
Study Completion Date
October 12, 2004 (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 North America. The aim of this trial is asses the long term safety and efficacy of biphasic insulin aspart 30 in Canadian subjects with type 2 diabetes who had participated in the BIAsp-1237 trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (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
Dose individually adjusted. Injected twice daily immediately before breakfast and dinner. Administrated subcutaneously (s.c., under the skin)
Primary Outcome Measure Information:
Title
HbA1c
Secondary Outcome Measure Information:
Title
Occurrence of adverse events
Title
Occurence of hypoglycaemic episodes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Completed the BIAsp-1237 trial
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
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Edmonton
ZIP/Postal Code
T5H 3V9
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Windsor
ZIP/Postal Code
N8W 3K2
Country
Canada
12. IPD Sharing Statement
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Long Term Safety and Efficacy of Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes
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