Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01467375




Registration number
NCT01467375
Ethics application status
Date submitted
4/11/2011
Date registered
8/11/2011
Date last updated
24/02/2017

Titles & IDs
Public title
Long Term Safety and Efficacy of Biphasic Insulin Aspart 30 in Type 2 Diabetes
Scientific title
An Open Label, Non Comparative, Multicentre Extension Trial to Assess the Long Term Safety and Efficacy of Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes Who Have Completed BIAsp-1234
Secondary ID [1] 0 0
BIASP-1361
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 0 0
Diabetes Mellitus, Type 2 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - biphasic insulin aspart

Experimental: A -


Treatment: Drugs: biphasic insulin aspart
Individually adjusted dose, injected s.c. (under the skin) before breakfast and dinner
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Occurrence of adverse events
Timepoint [1] 0 0
Primary outcome [2] 0 0
Frequency of hypoglycaemic episodes
Timepoint [2] 0 0
Secondary outcome [1] 0 0
HbA1c (glycosylated haemoglobin)
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
* Subjects must have been correctly included in and completed BIAsp-1234
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/01/2001
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/10/2004
Sample size
Target
Accrual to date
Final
89
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Novo Nordisk Investigational Site - Broadmeadow
Recruitment hospital [2] 0 0
Novo Nordisk Investigational Site - Parkville
Recruitment hospital [3] 0 0
Novo Nordisk Investigational Site - Ashford
Recruitment hospital [4] 0 0
Novo Nordisk Investigational Site - Auchenflower
Recruitment hospital [5] 0 0
Novo Nordisk Investigational Site - Launceston
Recruitment hospital [6] 0 0
Novo Nordisk Investigational Site - Nowra
Recruitment hospital [7] 0 0
Novo Nordisk Investigational Site - Ringwood
Recruitment hospital [8] 0 0
Novo Nordisk Investigational Site - Rooty Hill
Recruitment postcode(s) [1] 0 0
2292 - Broadmeadow
Recruitment postcode(s) [2] 0 0
3052 - Parkville
Recruitment postcode(s) [3] 0 0
5035 - Ashford
Recruitment postcode(s) [4] 0 0
4066 - Auchenflower
Recruitment postcode(s) [5] 0 0
7250 - Launceston
Recruitment postcode(s) [6] 0 0
2540 - Nowra
Recruitment postcode(s) [7] 0 0
3134 - Ringwood
Recruitment postcode(s) [8] 0 0
2766 - Rooty Hill
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Hull
Country [2] 0 0
Canada
State/province [2] 0 0
London
Country [3] 0 0
Canada
State/province [3] 0 0
Quebec
Country [4] 0 0
Canada
State/province [4] 0 0
Saskatoon

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novo Nordisk A/S
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Global Clinical Registry (GCR, 1452)
Address 0 0
Novo Nordisk A/S
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01467375