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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00569400




Registration number
NCT00569400
Ethics application status
Date submitted
5/12/2007
Date registered
7/12/2007
Date last updated
27/02/2017

Titles & IDs
Public title
Comparison of Human Insulin Produced by the Current Process and the NN729 Process in Type 1 Diabetes
Scientific title
Comparison of Efficacy and Safety of Human Insulin Produced by the Current Process and the NN729 Process in Type 1 Diabetes Mellitus
Secondary ID [1] 0 0
NN729-1541
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 0 0
Diabetes Mellitus, Type 1 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
Change of human insulin antibodies
Timepoint [1] 0 0
after 26 weeks of treatment
Secondary outcome [1] 0 0
Change of human insulin antibodies
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Frequency of adverse events
Timepoint [2] 0 0

Eligibility
Key inclusion criteria
* Duration of diabetes for at least 12 months
* Basal/bolus treatment with human insulin for at least 2 months preceding trial start
* Body Mass Index (BMI) lesser than or equal to 35.0 kg/m2
* HbA1c lesser than or equal to 12.0%
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Proliferative retinopathy or maculopathy requiring acute treatment or laser treatment within the last 6 months
* Any condition that the investigator and/or sponsor feel would interfere with trial participation
* Known or suspected allergy against trial product or related products

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 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
1/05/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/01/2004
Sample size
Target
Accrual to date
Final
241
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
Novo Nordisk Investigational Site - Broadmeadow
Recruitment hospital [2] 0 0
Novo Nordisk Investigational Site - Keswick
Recruitment hospital [3] 0 0
Novo Nordisk Investigational Site - Dunedin
Recruitment hospital [4] 0 0
Novo Nordisk Investigational Site - Hamilton
Recruitment hospital [5] 0 0
Novo Nordisk Investigational Site - Kippa Ring
Recruitment hospital [6] 0 0
Novo Nordisk Investigational Site - Miranda
Recruitment hospital [7] 0 0
Novo Nordisk Investigational Site - Stones Corner
Recruitment postcode(s) [1] 0 0
2292 - Broadmeadow
Recruitment postcode(s) [2] 0 0
5035 - Keswick
Recruitment postcode(s) [3] 0 0
NZ - Dunedin
Recruitment postcode(s) [4] 0 0
NZ - Hamilton
Recruitment postcode(s) [5] 0 0
4021 - Kippa Ring
Recruitment postcode(s) [6] 0 0
2228 - Miranda
Recruitment postcode(s) [7] 0 0
4120 - Stones Corner
Recruitment outside Australia
Country [1] 0 0
Hong Kong
State/province [1] 0 0
Shatin, New Territories
Country [2] 0 0
Malaysia
State/province [2] 0 0
Cheras
Country [3] 0 0
Malaysia
State/province [3] 0 0
Georgetown, Penang
Country [4] 0 0
Malaysia
State/province [4] 0 0
Kota Bharu, Kelantan
Country [5] 0 0
Philippines
State/province [5] 0 0
Cebu City
Country [6] 0 0
Philippines
State/province [6] 0 0
Iloilo
Country [7] 0 0
Philippines
State/province [7] 0 0
Makati City
Country [8] 0 0
Philippines
State/province [8] 0 0
Marikina City

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/NCT00569400