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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
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 completed the BIAsp-1234 trial.
Trial website
https://clinicaltrials.gov/study/NCT01467375
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01467375