Comparison of NPH Insulin and Insulin Detemir in Children and Adolescents With Type 1 Diabetes
NCT ID: NCT00435019
Last Updated: 2017-03-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
348 participants
INTERVENTIONAL
2007-02-28
2008-09-30
Brief Summary
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The aim of this research is to compare the efficacy and safety of treatment with NPH insulin and insulin detemir. You will be treated with either insulin detemir or NPH insulin once or twice daily as basal insulin. Additionally you will receive insulin aspart as bolus insulin
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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insulin detemir
insulin detemir + insulin aspart
insulin detemir
s.c. injection, once or twice daily.
insulin aspart
s.c. injection, at main meals.
NPH insulin
NPH insulin + insulin aspart
insulin NPH
s.c. injection, once or twice daily.
insulin aspart
s.c. injection, at main meals.
Interventions
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insulin detemir
s.c. injection, once or twice daily.
insulin NPH
s.c. injection, once or twice daily.
insulin aspart
s.c. injection, at main meals.
Eligibility Criteria
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Inclusion Criteria
* Type 1 diabetes for at least 12 months
* HbA1c lesser than or equal to 11.0%
Exclusion Criteria
2 Years
16 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Pleven, , Bulgaria
Novo Nordisk Investigational Site
Sofia, , Bulgaria
Novo Nordisk Investigational Site
Varna, , Bulgaria
Novo Nordisk Investigational Site
Olomouc, , Czechia
Novo Nordisk Investigational Site
Pardubice, , Czechia
Novo Nordisk Investigational Site
Prague, , Czechia
Novo Nordisk Investigational Site
Glostrup Municipality, , Denmark
Novo Nordisk Investigational Site
Kolding, , Denmark
Novo Nordisk Investigational Site
Odense, , Denmark
Novo Nordisk Investigational Site
Viborg, , Denmark
Novo Nordisk Investigational Site
Espoo, , Finland
Novo Nordisk Investigational Site
Helsinki, , Finland
Novo Nordisk Investigational Site
Oulu, , Finland
Novo Nordisk Investigational Site
Seinäjoki, , Finland
Novo Nordisk Investigational Site
Tampere, , Finland
Novo Nordisk Investigational Site
Turku, , Finland
Novo Nordisk Investigational Site
Angers, , France
Novo Nordisk Investigational Site
Montpellier, , France
Novo Nordisk Investigational Site
Paris, , France
Novo Nordisk Investigational Site
Toulouse, , France
Novo Nordisk Investigational Site
Budapest, , Hungary
Novo Nordisk Investigational Site
Miskolc, , Hungary
Novo Nordisk Investigational Site
Skopje, , North Macedonia
Novo Nordisk Investigational Site
Gdansk, , Poland
Novo Nordisk Investigational Site
Kielce, , Poland
Novo Nordisk Investigational Site
Siedlce, , Poland
Novo Nordisk Investigational Site
Warsaw, , Poland
Novo Nordisk Investigational Site
Warsaw, , Poland
Novo Nordisk Investigational Site
Warsaw, , Poland
Novo Nordisk Investigational Site
Moscow, , Russia
Novo Nordisk Investigational Site
Moscow, , Russia
Novo Nordisk Investigational Site
Moscow, , Russia
Novo Nordisk Investigational Site
Saint Petersburg, , Russia
Novo Nordisk Investigational Site
Altunizade-Istanbul, , Turkey (Türkiye)
Novo Nordisk Investigational Site
Antalya, , Turkey (Türkiye)
Novo Nordisk Investigational Site
Istanbul, , Turkey (Türkiye)
Novo Nordisk Investigational Site
Izmir, , Turkey (Türkiye)
Novo Nordisk Investigational Site
Kayseri, , Turkey (Türkiye)
Novo Nordisk Investigational Site
Aberdeen, , United Kingdom
Novo Nordisk Investigational Site
Birmingham, , United Kingdom
Novo Nordisk Investigational Site
Cambridge, , United Kingdom
Novo Nordisk Investigational Site
Dundee, , United Kingdom
Novo Nordisk Investigational Site
Norfolk, , United Kingdom
Countries
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References
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Thalange N, Bereket A, Larsen J, Hiort LC, Peterkova V. Treatment with insulin detemir or NPH insulin in children aged 2-5 yr with type 1 diabetes mellitus. Pediatr Diabetes. 2011 Nov;12(7):632-41. doi: 10.1111/j.1399-5448.2010.00750.x. Epub 2011 Mar 21.
Thalange N, Bereket A, Larsen J, Hiort LC, Peterkova V. Insulin analogues in children with Type 1 diabetes: a 52-week randomized clinical trial. Diabet Med. 2013 Feb;30(2):216-25. doi: 10.1111/dme.12041.
Thalange N, Bereket A, Jensen LB, Hiort LC, Peterkova V. Development of Insulin Detemir/Insulin Aspart Cross-Reacting Antibodies Following Treatment with Insulin Detemir: 104-week Study in Children and Adolescents with Type 1 Diabetes Aged 2-16 Years. Diabetes Ther. 2016 Dec;7(4):713-724. doi: 10.1007/s13300-016-0196-5. Epub 2016 Sep 6.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2006-000051-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NN304-1689
Identifier Type: -
Identifier Source: org_study_id
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