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.
Study Type
OBSERVATIONAL
Enrollment
1,056
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
Incidence of adverse events (AEs) by preferred term
Time frame: During 1 year of treatment
Incidence of serious adverse events (SAEs) by preferred term
Time frame: During 1 year of treatment
Incidence of serious adverse drug reactions (SADRs) by preferred term
Time frame: During 1 year of treatment
Incidence of adverse drug reactions (ADRs) by preferred term
Time frame: During 1 year of treatment
Incidence of severe hypoglycaemia
Time frame: During 1 year of treatment
Change from baseline in glycosylated haemoglobin (HbA1c)
Time frame: Baseline (Visit 1, week 0), end of study (Visit 4, week 52)
Change from baseline in fasting plasma glucose (FPG)
Time frame: Baseline (Visit 1, week 0), end of study (Visit 4, week 52)
Incidence of confirmed hypoglycaemia
Time frame: During 1 year of treatment
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Novo Nordisk Investigational Site
Guntur, Andhra Pradesh, India
Novo Nordisk Investigational Site
Hyderabad, Andhra Pradesh, India
Novo Nordisk Investigational Site
Hyderabad, Andhra Pradesh, India
Novo Nordisk Investigational Site
Hyderabad, Andhra Pradesh, India
Novo Nordisk Investigational Site
Hyderabad, Andhra Pradesh, India
Novo Nordisk Investigational Site
Vijayawada, Andhra Pradesh, India
Novo Nordisk Investigational Site
Guwahati, Assam, India
Novo Nordisk Investigational Site
Ahmedabad, Gujarat, India
Novo Nordisk Investigational Site
Ahmedabad, Gujarat, India
Novo Nordisk Investigational Site
Ghuma, Gujarat, India
...and 28 more locations