Evaluation of the Efficacy and Safety of Insulin Detemir Compared With That of NPH Insulin in Subjects With Type 1 Diabetes.
NCT ID: NCT03220425
Last Updated: 2017-07-18
Study Results
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Basic Information
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COMPLETED
PHASE3
752 participants
INTERVENTIONAL
2001-02-01
2001-11-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
NONE
Study Groups
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Insulin detemir
Insulin detemir
NPH insulin
NPH insulin
Interventions
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Insulin detemir
NPH insulin
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Locations
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Novo Nordisk Investigational Site
Broadmeadow, New South Wales, Australia
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Ashford, , Australia
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Box Hill, , Australia
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Clayton, , Australia
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Garran, , Australia
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Ringwood, , Australia
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Stones Corner, , Australia
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Woodville, , Australia
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Bornem, , Belgium
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Edegem, , Belgium
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Ghent, , Belgium
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Leuven, , Belgium
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Luxembourg, , Belgium
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Århus C, , Denmark
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Copenhagen, , Denmark
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Fredericia, , Denmark
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Frederiksberg, , Denmark
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Hvidovre, , Denmark
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Middelfart, , Denmark
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Odense, , Denmark
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Vejle, , Denmark
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Espoo, , Finland
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Helsinki, , Finland
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Joensuu, , Finland
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Kemi, , Finland
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Vantaa, , Finland
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Angers, , France
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Avignon, , France
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Bondy, , France
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Corbeil-Essonnes, , France
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La Rochelle, , France
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Le Creusot, , France
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Montpellier, , France
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Narbonne, , France
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Nevers, , France
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Paris, , France
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Paris, , France
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Paris, , France
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Poitiers, , France
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Rennes, , France
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Dublin, , Ireland
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Dublin, , Ireland
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Amersfoort, , Netherlands
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Apeldoorn, , Netherlands
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Brunssum, , Netherlands
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Eindhoven, , Netherlands
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Haarlem, , Netherlands
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Hengelo, , Netherlands
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The Hague, , Netherlands
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Utrecht, , Netherlands
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Bergen, , Norway
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Jessheim, , Norway
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Kongsvinger, , Norway
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Oslo, , Norway
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Oslo, , Norway
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Sarpsborg, , Norway
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Stavanger, , Norway
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Stord, , Norway
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Trondheim, , Norway
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Falun, , Sweden
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Helsingborg, , Sweden
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Karlstad, , Sweden
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Lund, , Sweden
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Örebro, , Sweden
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Skövde, , Sweden
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Stockholm, , Sweden
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Umeå, , Sweden
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Uppsala, , Sweden
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Värnamo, , Sweden
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Abergavenny, , United Kingdom
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Blackburn, , United Kingdom
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Bolton, , United Kingdom
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Bristol, , United Kingdom
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Cosham, , United Kingdom
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Derby, , United Kingdom
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Gillingham, , United Kingdom
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Glasgow, , United Kingdom
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Glasgow, , United Kingdom
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Guildford, , United Kingdom
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Kettering, , United Kingdom
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Livingstone, , United Kingdom
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Llantrisant, , United Kingdom
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London, , United Kingdom
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Newcastle, , United Kingdom
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Northampton, , United Kingdom
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Norwich, , United Kingdom
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Nottingham, , United Kingdom
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Oxford, , United Kingdom
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Sheffield, , United Kingdom
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Sidcup, , United Kingdom
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Stevenage, , United Kingdom
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Taunton, , United Kingdom
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York, , United Kingdom
Countries
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References
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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.
Other Identifiers
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NN304-1335
Identifier Type: -
Identifier Source: org_study_id
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