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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/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
Treatment: Drugs - human insulin

Treatment: Drugs: human insulin
Intervention code [1] 0 0
Treatment: Drugs
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
This trial is conducted in Asia and Oceania. The aim of this trial is to compare the efficacy
and safety of human insulin produced by the current process and the NN729 process in type 1
diabetes.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00569400
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/NCT00569400