This trial is conducted in Europe. The aim of this observational study is to evaluate the incidence of major hypoglycaemic episodes in patients with type 2 diabetes treated with NovoRapid® or Soluble Human Insulin under normal clinical practice conditions.
Study Type
OBSERVATIONAL
Enrollment
4,099
Observational study; use of the products as in the normal clinical practice conditions
Observational study; use of the products as in the normal clinical practice conditions
Novo Nordisk Investigational Site
Rome, Italy
Number of major hypoglycaemic events reported as serious adverse drug reactions
Time frame: after 26 weeks
Number of serious and non serious drug reactions
Time frame: during 26 weeks
Number of serious adverse event
Time frame: during 26 weeks
Number of all major (daytime and nocturnal) hypoglycaemic events
Time frame: during 26 weeks
Number of major hypoglycaemic events related to omission of a meal after injection
Time frame: during 26 weeks
Number of major hypoglycaemic events related to physical exercise of at least 30 min duration
Time frame: during 26 weeks
Number of all minor (daytime and nocturnal) hypoglycaemic events during 4 weeks preceding each study visit
Time frame: after 26 weeks
Weight and waist circumference change
Time frame: during 26 weeks
Number of hypoglycaemia events in the two different treatment groups based on the HbA1c level
Time frame: after 26 weeks
Quality of Life (QoL)
Time frame: after 26 weeks
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