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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03220425




Registration number
NCT03220425
Ethics application status
Date submitted
13/07/2017
Date registered
18/07/2017
Date last updated
18/07/2017

Titles & IDs
Public title
Evaluation of the Efficacy and Safety of Insulin Detemir Compared With That of NPH Insulin in Subjects With Type 1 Diabetes.
Scientific title
A Six Month, Multi-centre, Open-label, Parallel Efficacy and Safety Comparison of Insulin Detemir and NPH Insulin in Subjects With Type 1 Diabetes on a Basal-bolus Regimen.
Secondary ID [1] 0 0
NN304-1335
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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 - Insulin detemir
Treatment: Drugs - NPH insulin

Experimental: Insulin detemir -

Active Comparator: NPH insulin -


Treatment: Drugs: Insulin detemir


Treatment: Drugs: NPH insulin


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The change in the level of glycosylated haemoglobin(HbA1c)
Timepoint [1] 0 0
From start of treatment visit 2 (week 0) until end of treatment visit 8 (week 26)

Eligibility
Key inclusion criteria
- Signed and dated informed consent obtained before any trial-related activities

- Type 1 diabetes diagnosed and classified according to aetiology

- Duration of type 1 diabetes equal to or more than 12 months

- Glycosylated haemoglobin less than or equal to 12 percent based on analysis from
central laboratory

- Able and willing to perform self-blood glucose monitoring
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Proliferative retinopathy

- Total basal insulin dose of more than 100 IU per day

- Recurrent major hypoglycaemia - that would interfere with trial participation (as
judged by the investigator)

- Known unawareness of hypoglycaemia

- Previous treatment with insulin detemir

Study design
Purpose of the study
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Novo Nordisk Investigational Site - Broadmeadow
Recruitment hospital [2] 0 0
Novo Nordisk Investigational Site - Ashford
Recruitment hospital [3] 0 0
Novo Nordisk Investigational Site - Box Hill
Recruitment hospital [4] 0 0
Novo Nordisk Investigational Site - Clayton
Recruitment hospital [5] 0 0
Novo Nordisk Investigational Site - Garran
Recruitment hospital [6] 0 0
Novo Nordisk Investigational Site - Ringwood
Recruitment hospital [7] 0 0
Novo Nordisk Investigational Site - Stones Corner
Recruitment hospital [8] 0 0
Novo Nordisk Investigational Site - Woodville
Recruitment postcode(s) [1] 0 0
2292 - Broadmeadow
Recruitment postcode(s) [2] 0 0
5035 - Ashford
Recruitment postcode(s) [3] 0 0
3128 - Box Hill
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment postcode(s) [5] 0 0
2605 - Garran
Recruitment postcode(s) [6] 0 0
3134 - Ringwood
Recruitment postcode(s) [7] 0 0
4120 - Stones Corner
Recruitment postcode(s) [8] 0 0
5011 - Woodville
Recruitment outside Australia
Country [1] 0 0
Belgium
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Bornem
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Belgium
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Edegem
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Belgium
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Gent
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Belgium
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Leuven
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Belgium
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Luxembourg
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Denmark
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Fredericia
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Frederiksberg
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Hvidovre
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København
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Middelfart
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Odense
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Vejle
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Århus C
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Finland
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Espoo
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Finland
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Helsinki
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Finland
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Joensuu
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Finland
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Kemi
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Finland
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Vantaa
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France
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ANGERS cedex 09
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France
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Avignon
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Bondy
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Paris
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Karlstad
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Stockholm
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Umeå
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Uppsala
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Värnamo
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Örebro
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Abergavenny
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Blackburn
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Bolton
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Bristol
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Cosham
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Gillingham
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Kettering
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Livingstone
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Taunton
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York

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novo Nordisk A/S
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The aim of this trial is to evaluate the efficacy and safety of insulin detemir using the
2400 nmol/mL formulation to optimise dosing in subjects with type 1 diabetes on a basal (once
daily)-bolus regimen.
Trial website
https://clinicaltrials.gov/show/NCT03220425
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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
Other publications