Clinical trial NCT02392117: Investigating the Safety and Effectiveness of Insulin Degludec in a Real World Population With Type 1 and 2 Diabetes Mellitus
Official title: A Multi-centre, Prospective, Non-interventional Study of Insulin Degludec Investigating the Safety and Effectiveness in a Real World Population With Type 1 and 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2015-03-18
Enrollment: 1262
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male or female patients aged at least 18 years of age with either T1DM or T2DM (insulin using) (clinically diagnosed) prior to visit 1, who signed an informed consent form, and whose physician plans to start Tresiba® treatment are eligible for entry in this study.

Brief summary: This study is conducted in Europe. The aim of this non-interventional study is to investigate the safety and effectiveness of insulin degludec (Tresiba®) in a real world population with type 1 (T1DM) and 2 (T2DM) diabetes mellitus.


Eligibility criteria: Inclusion Criteria:

* Informed consent obtained before any study-related activities (Study-related activities are any procedure related to recording of data according to the protocol)
* 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:

* Known or suspected hypersensitivity to Tresiba® or any of the excipients listed in Section 6.1 of the SmPC (Summary of Product Characteristics) or related products
* 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

Primary outcomes:
measure: Change in the number of any hypoglycaemic episodes
timeFrame: End of 4 week baseline period, end of 12 month observation period
Secondary outcomes:
measure: Change from baseline in HbA1c (glycosylated haemoglobin)
timeFrame: 0- 12 months
measure: Change from baseline in FPG (Fasting Plasma Glucose)
timeFrame: 0-12 months
measure: Change from the baseline period in the number of severe hypoglycaemic episodes
timeFrame: 0-12 months
measure: Change from baseline in HR-QoL (health-related quality of life) questionnaire scores (PROs (patient reported outcome): SF-36 (short form 36), and DTSQ(Diabetes Treatment Satisfaction Questionnaire ))
timeFrame: 0-12 months
Other outcomes:
Locations:
city: Århus
country: Denmark
facility: Novo Nordisk Investigational Site
city: München
country: Germany
facility: Novo Nordisk Investigational Site
city: Padova
country: Italy
facility: Novo Nordisk Investigational Site
city: Utrecht
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Palma de Mallorca
country: Spain
facility: Novo Nordisk Investigational Site
city: Karlstad
country: Sweden
facility: Novo Nordisk Investigational Site
city: Zürich
country: Switzerland
facility: Novo Nordisk Investigational Site
city: London
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.