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/NCT00605111




Registration number
NCT00605111
Ethics application status
Date submitted
18/01/2008
Date registered
30/01/2008
Date last updated
11/01/2017

Titles & IDs
Public title
Efficacy and Safety of Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes
Scientific title
Efficacy and Safety of Initiation of Biphasic Insulin Aspart 30 Treatment in Subjects With Type 2 Diabetes Mellitus Failing OAD Therapy
Secondary ID [1] 0 0
BIASP-3021
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
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
HbA1c
Timepoint [1] 0 0
after 11 weeks of treatment
Secondary outcome [1] 0 0
The proportion of subjects achieving treatment target of HbA1c below 7%
Timepoint [1] 0 0
at 11 and 24 weeks
Secondary outcome [2] 0 0
8-point plasma glucose profiles
Timepoint [2] 0 0
performed at 11 and 24 weeks
Secondary outcome [3] 0 0
FPG
Timepoint [3] 0 0
at 11 weeks and 24 weeks

Eligibility
Key inclusion criteria
* Type 2 diabetes for at least 24 months
* BMI between 18 and 30 kg/m2
* Insulin naive subjects
* OAD treatment with max two OADs alone or combined with other therapy
* HbA1c between 7-12%
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Type 1 diabetes
* Receipt of any investigational drug within the last three months prior to this trial
* Current or previous treatment with thiazolidiones within the last 6 months
* OAD treatment with three or more OADs within the last 4 months

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Parallel
Other design features
Phase
Phase 4
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
1/12/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2004
Sample size
Target
Accrual to date
Final
193
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Novo Nordisk Investigational Site - Blacktown
Recruitment hospital [2] 0 0
Novo Nordisk Investigational Site - Broadmeadow
Recruitment hospital [3] 0 0
Novo Nordisk Investigational Site - Fitzroy
Recruitment hospital [4] 0 0
Novo Nordisk Investigational Site - Garran
Recruitment hospital [5] 0 0
Novo Nordisk Investigational Site - Stones Corner
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2292 - Broadmeadow
Recruitment postcode(s) [3] 0 0
3065 - Fitzroy
Recruitment postcode(s) [4] 0 0
2605 - Garran
Recruitment postcode(s) [5] 0 0
4120 - Stones Corner
Recruitment outside Australia
Country [1] 0 0
Hong Kong
State/province [1] 0 0
Hong Kong Island
Country [2] 0 0
Hong Kong
State/province [2] 0 0
Shatin, New Territories
Country [3] 0 0
Malaysia
State/province [3] 0 0
Cheras
Country [4] 0 0
Malaysia
State/province [4] 0 0
Georgetown, Penang
Country [5] 0 0
Malaysia
State/province [5] 0 0
Kota Bharu, Kelantan
Country [6] 0 0
Philippines
State/province [6] 0 0
Cebu City
Country [7] 0 0
Philippines
State/province [7] 0 0
Quezon City
Country [8] 0 0
Singapore
State/province [8] 0 0
Singapore
Country [9] 0 0
Taiwan
State/province [9] 0 0
Changhua
Country [10] 0 0
Taiwan
State/province [10] 0 0
Kaoshiung
Country [11] 0 0
Thailand
State/province [11] 0 0
Bangkok

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

TypeCitations or Other Details
Journal Bebakar WM, Chow CC, Kadir KA, Suwanwalaikorn S, V... [More Details]

Results not provided in https://clinicaltrials.gov/study/NCT00605111