Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Conditions
Brief summary
This study is conducted in Asia. The aim of the study is to evaluate long term safety and efficacy of Tresiba® (insulin degludec) in patients with diabetes mellitus in routine clinical practice in India.
Interventions
DRUGinsulin degludec
Treatment according to routine clinical practice at the discretion of the treating physician. The assignment of the patient to Tresiba® is decided in advance of this study
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
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). The historical data including the data before informed consent obtained (e.g. glycosylated haemoglobin (HbA1c), fasting plasma glucose (FPG), severe hypoglycaemia before the start of Tresiba® therapy) can be used for baseline data * Patients with insulin requiring diabetes mellitus and who is scheduled to start treatment with Tresiba® based on the clinical judgment of their treating physician
Exclusion criteria
* Known or suspected allergy to Tresiba®, the active substance or any of the excipients * Previous participation in this study * Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation * Patients who are or have previously been on Tresiba® therapy * Patients who are participating in other studies or clinical trials * Patients who are pregnant, breast feeding or have the intention of becoming pregnant within the following 12 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events (AEs) by preferred term | During 1 year of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of serious adverse drug reactions (SADRs) by preferred term | During 1 year of treatment |
| Incidence of adverse drug reactions (ADRs) by preferred term | During 1 year of treatment |
| Incidence of severe hypoglycaemia | During 1 year of treatment |
| Incidence of serious adverse events (SAEs) by preferred term | During 1 year of treatment |
| Change from baseline in fasting plasma glucose (FPG) | Baseline (Visit 1, week 0), end of study (Visit 4, week 52) |
| Incidence of confirmed hypoglycaemia | During 1 year of treatment |
| Change from baseline in glycosylated haemoglobin (HbA1c) | Baseline (Visit 1, week 0), end of study (Visit 4, week 52) |
Countries
India
Outcome results
None listed