Investigating the Safety and Effectiveness of Insulin Degludec in a Real World Population With Type 1 and 2 Diabetes Mellitus
NCT ID: NCT02392117
Last Updated: 2019-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1262 participants
OBSERVATIONAL
2015-03-16
2018-03-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Insulin degludec
insulin degludec
Tresiba® will be prescribed by the physician under normal clinical practice conditions and will be obtained/ purchased from the chemist based on physician prescription. No treatment given.
Interventions
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insulin degludec
Tresiba® will be prescribed by the physician under normal clinical practice conditions and will be obtained/ purchased from the chemist based on physician prescription. No treatment given.
Eligibility Criteria
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Inclusion Criteria
* Male or female patients at least 18 years of age at time of informed consent
* T1DM (diagnosed clinically) prior to inclusion in the study, and/or T2DM, insulin using patients (diagnosed clinically) prior to inclusion in the study
* Planned initiation with Tresiba®
Exclusion Criteria
* Previous participation in this study (i.e. provision of informed consent)
* Patients who have previously been treated with Tresiba®
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
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
Aarhus, , Denmark
Novo Nordisk Investigational Site
München, , Germany
Novo Nordisk Investigational Site
Padua, , Italy
Novo Nordisk Investigational Site
Utrecht, , Netherlands
Novo Nordisk Investigational Site
Palma de Mallorca, , Spain
Novo Nordisk Investigational Site
Karlstad, , Sweden
Novo Nordisk Investigational Site
Zurich, , Switzerland
Novo Nordisk Investigational Site
London, , United Kingdom
Countries
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References
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Fadini GP, Feher M, Hansen TK, de Valk HW, Koefoed MM, Wolden M, Zimmermann E, Jendle J. Switching to Degludec From Other Basal Insulins Is Associated With Reduced Hypoglycemia Rates: A Prospective Study. J Clin Endocrinol Metab. 2019 Dec 1;104(12):5977-5990. doi: 10.1210/jc.2019-01021.
Fadini GP, Giordano C, Salvi L, Nicolucci A; REFLECT Italian Study Group. Reduced Rates of Hypoglycemia in Type 1 or Type 2 Diabetes After Switching to Insulin Degludec: Results from the Italian Cohort of the ReFLeCT Study. Diabetes Ther. 2020 Dec;11(12):2909-2920. doi: 10.1007/s13300-020-00936-5. Epub 2020 Oct 3.
de Valk HW, Feher M, Hansen TK, Jendle J, Koefoed MM, Rizi EP, Zimmermann E, Fadini GP. Switching to Degludec is Associated with Reduced Hypoglycaemia, Irrespective of Definition Used or Patient Characteristics: Secondary Analysis of the ReFLeCT Prospective, Observational Study. Diabetes Ther. 2020 Sep;11(9):2159-2167. doi: 10.1007/s13300-020-00875-1. Epub 2020 Jul 14.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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U1111-1158-0248
Identifier Type: OTHER
Identifier Source: secondary_id
ENCEPP/SDPP/7880
Identifier Type: OTHER
Identifier Source: secondary_id
NN1250-4189
Identifier Type: -
Identifier Source: org_study_id
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