Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Country [2] 0 0
Belgium
State/province [2] 0 0
Edegem
Country [3] 0 0
Belgium
State/province [3] 0 0
Gent
Country [4] 0 0
Belgium
State/province [4] 0 0
Leuven
Country [5] 0 0
Belgium
State/province [5] 0 0
Luxembourg
Country [6] 0 0
Denmark
State/province [6] 0 0
Fredericia
Country [7] 0 0
Denmark
State/province [7] 0 0
Frederiksberg
Country [8] 0 0
Denmark
State/province [8] 0 0
Hvidovre
Country [9] 0 0
Denmark
State/province [9] 0 0
København
Country [10] 0 0
Denmark
State/province [10] 0 0
Middelfart
Country [11] 0 0
Denmark
State/province [11] 0 0
Odense
Country [12] 0 0
Denmark
State/province [12] 0 0
Vejle
Country [13] 0 0
Denmark
State/province [13] 0 0
Århus C
Country [14] 0 0
Finland
State/province [14] 0 0
Espoo
Country [15] 0 0
Finland
State/province [15] 0 0
Helsinki
Country [16] 0 0
Finland
State/province [16] 0 0
Joensuu
Country [17] 0 0
Finland
State/province [17] 0 0
Kemi
Country [18] 0 0
Finland
State/province [18] 0 0
Vantaa
Country [19] 0 0
France
State/province [19] 0 0
ANGERS cedex 09
Country [20] 0 0
France
State/province [20] 0 0
Avignon
Country [21] 0 0
France
State/province [21] 0 0
Bondy
Country [22] 0 0
France
State/province [22] 0 0
Corbeil Essonnes
Country [23] 0 0
France
State/province [23] 0 0
LA ROCHELLE cedex
Country [24] 0 0
France
State/province [24] 0 0
Le Creusot
Country [25] 0 0
France
State/province [25] 0 0
MONTPELLIER cedex 5
Country [26] 0 0
France
State/province [26] 0 0
Narbonne
Country [27] 0 0
France
State/province [27] 0 0
NEVERS cedex
Country [28] 0 0
France
State/province [28] 0 0
Paris Cedex 10
Country [29] 0 0
France
State/province [29] 0 0
Paris
Country [30] 0 0
France
State/province [30] 0 0
Poitiers
Country [31] 0 0
France
State/province [31] 0 0
Rennes
Country [32] 0 0
Ireland
State/province [32] 0 0
Dublin
Country [33] 0 0
Netherlands
State/province [33] 0 0
Amersfoort
Country [34] 0 0
Netherlands
State/province [34] 0 0
Apeldoorn
Country [35] 0 0
Netherlands
State/province [35] 0 0
Brunssum
Country [36] 0 0
Netherlands
State/province [36] 0 0
Den Haag
Country [37] 0 0
Netherlands
State/province [37] 0 0
Eindhoven
Country [38] 0 0
Netherlands
State/province [38] 0 0
Haarlem
Country [39] 0 0
Netherlands
State/province [39] 0 0
Hengelo
Country [40] 0 0
Netherlands
State/province [40] 0 0
Utrecht
Country [41] 0 0
Norway
State/province [41] 0 0
Bergen
Country [42] 0 0
Norway
State/province [42] 0 0
Jessheim
Country [43] 0 0
Norway
State/province [43] 0 0
Kongsvinger
Country [44] 0 0
Norway
State/province [44] 0 0
Oslo
Country [45] 0 0
Norway
State/province [45] 0 0
Sarpsborg
Country [46] 0 0
Norway
State/province [46] 0 0
Stavanger
Country [47] 0 0
Norway
State/province [47] 0 0
Stord
Country [48] 0 0
Norway
State/province [48] 0 0
Trondheim
Country [49] 0 0
Sweden
State/province [49] 0 0
Falun
Country [50] 0 0
Sweden
State/province [50] 0 0
Helsingborg
Country [51] 0 0
Sweden
State/province [51] 0 0
Karlstad
Country [52] 0 0
Sweden
State/province [52] 0 0
Lund
Country [53] 0 0
Sweden
State/province [53] 0 0
Skövde
Country [54] 0 0
Sweden
State/province [54] 0 0
Stockholm
Country [55] 0 0
Sweden
State/province [55] 0 0
Umeå
Country [56] 0 0
Sweden
State/province [56] 0 0
Uppsala
Country [57] 0 0
Sweden
State/province [57] 0 0
Värnamo
Country [58] 0 0
Sweden
State/province [58] 0 0
Örebro
Country [59] 0 0
United Kingdom
State/province [59] 0 0
Abergavenny
Country [60] 0 0
United Kingdom
State/province [60] 0 0
Blackburn
Country [61] 0 0
United Kingdom
State/province [61] 0 0
Bolton
Country [62] 0 0
United Kingdom
State/province [62] 0 0
Bristol
Country [63] 0 0
United Kingdom
State/province [63] 0 0
Cosham
Country [64] 0 0
United Kingdom
State/province [64] 0 0
Derby
Country [65] 0 0
United Kingdom
State/province [65] 0 0
Gillingham
Country [66] 0 0
United Kingdom
State/province [66] 0 0
Glasgow
Country [67] 0 0
United Kingdom
State/province [67] 0 0
Guildford
Country [68] 0 0
United Kingdom
State/province [68] 0 0
Kettering
Country [69] 0 0
United Kingdom
State/province [69] 0 0
Livingstone
Country [70] 0 0
United Kingdom
State/province [70] 0 0
Llantrisant
Country [71] 0 0
United Kingdom
State/province [71] 0 0
London
Country [72] 0 0
United Kingdom
State/province [72] 0 0
Newcastle
Country [73] 0 0
United Kingdom
State/province [73] 0 0
Northampton
Country [74] 0 0
United Kingdom
State/province [74] 0 0
Norwich
Country [75] 0 0
United Kingdom
State/province [75] 0 0
Nottingham
Country [76] 0 0
United Kingdom
State/province [76] 0 0
Oxford
Country [77] 0 0
United Kingdom
State/province [77] 0 0
Sheffield
Country [78] 0 0
United Kingdom
State/province [78] 0 0
Sidcup
Country [79] 0 0
United Kingdom
State/province [79] 0 0
Stevenage
Country [80] 0 0
United Kingdom
State/province [80] 0 0
Taunton
Country [81] 0 0
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