Status:
COMPLETED
Long Term Safety and Efficacy of Biphasic Insulin Aspart 30 in Type 2 Diabetes
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This trial is conducted in Oceania and North America. The aim of this trial is to assess the long term safety and efficacy of biphasic insulin aspart 30 in subjects with type 2 diabetes who have compl...
Eligibility Criteria
Inclusion
- Subjects must have been correctly included in and completed BIAsp-1234
Exclusion
- Persistent non-compliance with study medication, visit schedules or other trial specific procedures during the preceding trial
- Fulfilment of any withdrawal criteria prior to and including the final visit of the BIAsp-1234.
- Females only: breast feeding, intention of becoming pregnant, or judged to be using inadequate contraceptive measures (adequate contraceptive methods are sterilisation,IUD (Intra Uterine Device), oral contraceptives or barrier methods)
- Known or suspected allergy to trial product or related products
- Development since entry into the previous trial of late diabetic micro or macro vascular complications, which in the opinion of the Investigator indicates a progressed state of disease
Key Trial Info
Start Date :
January 8 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 22 2004
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT01467375
Start Date
January 8 2001
End Date
October 22 2004
Last Update
February 24 2017
Active Locations (12)
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1
Novo Nordisk Investigational Site
Broadmeadow, New South Wales, Australia, 2292
2
Novo Nordisk Investigational Site
Parkville, Victoria, Australia, 3052
3
Novo Nordisk Investigational Site
Ashford, Australia, 5035
4
Novo Nordisk Investigational Site
Auchenflower, Australia, 4066