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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
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
Experimental: Insulin detemir -

Active comparator: NPH insulin -

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
Sex
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
1/02/2001
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/11/2001
Sample size
Target
Accrual to date
Final
752
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
State/province [1] 0 0
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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Denmark
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Frederiksberg
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Denmark
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Hvidovre
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Denmark
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København
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Denmark
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Middelfart
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Denmark
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Odense
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Denmark
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Vejle
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Denmark
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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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France
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Bondy
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Corbeil Essonnes
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France
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LA ROCHELLE cedex
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Le Creusot
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MONTPELLIER cedex 5
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France
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Narbonne
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France
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NEVERS cedex
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France
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Paris Cedex 10
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France
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Paris
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Poitiers
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Rennes
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Ireland
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Dublin
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Amersfoort
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Netherlands
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Apeldoorn
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Netherlands
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Brunssum
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Den Haag
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Eindhoven
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Haarlem
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Hengelo
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Netherlands
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Utrecht
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Bergen
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Jessheim
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Kongsvinger
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Oslo
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Sarpsborg
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Stavanger
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Norway
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Stord
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Norway
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Trondheim
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Sweden
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Falun
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Sweden
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Helsingborg
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Karlstad
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Sweden
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Lund
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Sweden
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Skövde
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Sweden
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Stockholm
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Sweden
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Umeå
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Sweden
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Uppsala
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Sweden
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Värnamo
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Sweden
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Örebro
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United Kingdom
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Abergavenny
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United Kingdom
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Blackburn
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Bolton
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Bristol
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United Kingdom
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Cosham
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Derby
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Gillingham
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Glasgow
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Guildford
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Kettering
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United Kingdom
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Livingstone
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Llantrisant
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London
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Newcastle
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Northampton
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Norwich
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Nottingham
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Oxford
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Sheffield
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Sidcup
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Stevenage
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Taunton
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United Kingdom
State/province [81] 0 0
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/study/NCT03220425
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.
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03220425