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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Treatment: Drugs - biphasic insulin aspart

Treatment: Drugs: biphasic insulin aspart
Intervention code [1] 0 0
Treatment: Drugs
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
This trial is conducted in Asia. The aim of this trial is to investigate the efficacy and
safety of biphasic insulin aspart 30 as start insulin in subjects with type 2 diabetes
failing OAD therapy.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00605111
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/ct2/show/NCT00605111