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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03220425
Registration number
NCT03220425
Ethics application status
Date submitted
13/07/2017
Date registered
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.
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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.
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Secondary ID [1]
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NN304-1335
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 1
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Condition category
Condition code
Metabolic and Endocrine
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Experimental: Insulin detemir -
Active comparator: NPH insulin -
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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The change in the level of glycosylated haemoglobin(HbA1c)
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Assessment method [1]
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Timepoint [1]
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From start of treatment visit 2 (week 0) until end of treatment visit 8 (week 26)
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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
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Minimum age
18
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2001
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
12/11/2001
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Sample size
Target
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Accrual to date
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Final
752
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Novo Nordisk Investigational Site - Broadmeadow
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Recruitment hospital [2]
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Novo Nordisk Investigational Site - Ashford
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Recruitment hospital [3]
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Novo Nordisk Investigational Site - Box Hill
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Novo Nordisk Investigational Site - Clayton
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Novo Nordisk Investigational Site - Garran
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Novo Nordisk Investigational Site - Ringwood
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Novo Nordisk Investigational Site - Stones Corner
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Recruitment hospital [8]
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Novo Nordisk Investigational Site - Woodville
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Recruitment postcode(s) [1]
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2292 - Broadmeadow
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Recruitment postcode(s) [2]
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5035 - Ashford
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Recruitment postcode(s) [3]
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3128 - Box Hill
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3168 - Clayton
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2605 - Garran
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3134 - Ringwood
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4120 - Stones Corner
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5011 - Woodville
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Novo Nordisk A/S
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT03220425
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Trial related presentations / publications
Russell-Jones D, Simpson R, Hylleberg B, Draeger E, Bolinder J. Effects of QD insulin detemir or neutral protamine Hagedorn on blood glucose control in patients with type I diabetes mellitus using a basal-bolus regimen. Clin Ther. 2004 May;26(5):724-36. doi: 10.1016/s0149-2918(04)90072-0.
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Public notes
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Contacts
Principal investigator
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
According to the Novo Nordisk Disclosure commitment on novonordisk-trials.com
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Russell-Jones D, Simpson R, Hylleberg B, Draeger E...
[
More Details
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Results not provided in
https://clinicaltrials.gov/study/NCT03220425