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.
Study Type
OBSERVATIONAL
Enrollment
1,262
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.
Novo Nordisk Investigational Site
Aarhus, Denmark
Novo Nordisk Investigational Site
München, Germany
Novo Nordisk Investigational Site
Padova, Italy
Novo Nordisk Investigational Site
Utrecht, Netherlands
Change in the number of any hypoglycaemic episodes
Time frame: End of 4 week baseline period, end of 12 month observation period
Change from baseline in HbA1c (glycosylated haemoglobin)
Time frame: 0- 12 months
Change from baseline in FPG (Fasting Plasma Glucose)
Time frame: 0-12 months
Change from the baseline period in the number of severe hypoglycaemic episodes
Time frame: 0-12 months
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 ))
Time frame: 0-12 months
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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