Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Conditions
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.
Interventions
DRUGinsulin 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.
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the number of any hypoglycaemic episodes | End of 4 week baseline period, end of 12 month observation period |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in HbA1c (glycosylated haemoglobin) | 0- 12 months |
| Change from baseline in FPG (Fasting Plasma Glucose) | 0-12 months |
| Change from the baseline period in the number of severe hypoglycaemic episodes | 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 )) | 0-12 months |
Countries
Denmark, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, United Kingdom
Outcome results
None listed