Long Term Safety and Efficacy of Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes
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)
1 other identifier
interventional
25
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 diabetes
Started Nov 2001
Longer than P75 for phase_3 diabetes
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 23, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 12, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
October 12, 2004
CompletedFirst Submitted
Initial submission to the registry
February 2, 2012
CompletedFirst Posted
Study publicly available on registry
February 7, 2012
CompletedFebruary 24, 2017
February 1, 2017
2.9 years
February 2, 2012
February 22, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
HbA1c
Secondary Outcomes (2)
Occurrence of adverse events
Occurence of hypoglycaemic episodes
Study Arms (1)
BIAsp 30
EXPERIMENTALInterventions
Dose individually adjusted. Injected twice daily immediately before breakfast and dinner. Administrated subcutaneously (s.c., under the skin)
Eligibility Criteria
You may qualify if:
- Completed the BIAsp-1237 trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (4)
Novo Nordisk Investigational Site
Halifax, Nova Scotia, B3H 1V7, Canada
Novo Nordisk Investigational Site
Toronto, Ontario, M5B 1W8, Canada
Novo Nordisk Investigational Site
Edmonton, T5H 3V9, Canada
Novo Nordisk Investigational Site
Windsor, N8W 3K2, Canada
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2012
First Posted
February 7, 2012
Study Start
November 23, 2001
Primary Completion
October 12, 2004
Study Completion
October 12, 2004
Last Updated
February 24, 2017
Record last verified: 2017-02