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Clinical Trial Details

Trial ID: L4554
Source ID: NCT00435019
Associated Drug: Insulin Detemir
Title: Comparison of NPH Insulin and Insulin Detemir in Children and Adolescents With Type 1 Diabetes
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00435019/results
Conditions: Diabetes|Diabetes Mellitus, Type 1
Interventions: DRUG: insulin detemir|DRUG: insulin NPH|DRUG: insulin aspart
Outcome Measures: Primary: Glycosylated Haemoglobin A1c (HbA1c), Glycosylated haemoglobin A1c (HbA1c) measured after 52 weeks of treatment and analysed by central laboratory., after 52 weeks of treatment | Secondary: Number of Subjects Reporting Adverse Events, Number of subjects reporting adverse events during the trial (from week -2 to week 52). For details, please refer to the adverse events section., from week -2 to week 52|Observed Insulin Antibody Values, Observed insulin antibody values for insulin detemir specific antibodies, insulin aspart specific antibodies and insulin detemir/insulin aspart cross-reacting antibodies., at 0 and 52 weeks
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: CHILD
Phases: PHASE3
Enrollment: 348
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2007-02
Completion Date: 2008-09
Results First Posted: 2009-12-08
Last Update Posted: 2017-03-10
Locations: Novo Nordisk Investigational Site, Pleven, 5800, Bulgaria|Novo Nordisk Investigational Site, Sofia, 1606, Bulgaria|Novo Nordisk Investigational Site, Varna, 9010, Bulgaria|Novo Nordisk Investigational Site, Olomouc, 77520, Czech Republic|Novo Nordisk Investigational Site, Pardubice, 53203, Czech Republic|Novo Nordisk Investigational Site, Prague 5, 15018, Czech Republic|Novo Nordisk Investigational Site, Glostrup, 2600, Denmark|Novo Nordisk Investigational Site, Kolding, 6000, Denmark|Novo Nordisk Investigational Site, Odense, 5000, Denmark|Novo Nordisk Investigational Site, Viborg, 8800, Denmark|Novo Nordisk Investigational Site, Espoo, 02740, Finland|Novo Nordisk Investigational Site, Helsinki, 00029, Finland|Novo Nordisk Investigational Site, Oulu, 90029, Finland|Novo Nordisk Investigational Site, Seinäjoki, 60220, Finland|Novo Nordisk Investigational Site, Tampere, 33520, Finland|Novo Nordisk Investigational Site, Turku, 20100, Finland|Novo Nordisk Investigational Site, ANGERS cedex 09, 49033, France|Novo Nordisk Investigational Site, MONTPELLIER cedex 05, 34295, France|Novo Nordisk Investigational Site, Paris, 75015, France|Novo Nordisk Investigational Site, Toulouse, 31059, France|Novo Nordisk Investigational Site, Budapest, 1083, Hungary|Novo Nordisk Investigational Site, Miskolc, 3501, Hungary|Novo Nordisk Investigational Site, Skopje, 1000, Macedonia, The Former Yugoslav Republic of|Novo Nordisk Investigational Site, Gdansk, 80-211, Poland|Novo Nordisk Investigational Site, Kielce, 25-734, Poland|Novo Nordisk Investigational Site, Siedlce, 08-110, Poland|Novo Nordisk Investigational Site, Warszawa, 00-576, Poland|Novo Nordisk Investigational Site, Warszawa, 01-184, Poland|Novo Nordisk Investigational Site, Warszawa, 04-730, Poland|Novo Nordisk Investigational Site, Moscow, 117036, Russian Federation|Novo Nordisk Investigational Site, Moscow, 119049, Russian Federation|Novo Nordisk Investigational Site, Moscow, 125373, Russian Federation|Novo Nordisk Investigational Site, Saint-Petersburg, 191144, Russian Federation|Novo Nordisk Investigational Site, Altunizade-Istanbul, 34662, Turkey|Novo Nordisk Investigational Site, Antalya, 07059, Turkey|Novo Nordisk Investigational Site, Istanbul, 34093, Turkey|Novo Nordisk Investigational Site, Izmir, 35340, Turkey|Novo Nordisk Investigational Site, Kayseri, 38010, Turkey|Novo Nordisk Investigational Site, Aberdeen, AB25 2ZG, United Kingdom|Novo Nordisk Investigational Site, Birmingham, B4 6NH, United Kingdom|Novo Nordisk Investigational Site, Cambridge, CB2 2QQ, United Kingdom|Novo Nordisk Investigational Site, Dundee, DD1 9SY, United Kingdom|Novo Nordisk Investigational Site, Norfolk, NR4 7UY, United Kingdom
URL: https://clinicaltrials.gov/show/NCT00435019

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress