This study is conducted in Africa, Asia, Europe, Japan and South America. The aim of this observational study is to evaluate the incidence of serious adverse reactions (SARs) while using Levemir® (insulin detemir) under normal clinical practice conditions. Study conducted globally in 26 countries. Some countries participated in the study for only 3 months (Austria, Brazil, Denmark, Germany, Israel, Lebanon, Slovenia, Russia, and Turkey), while others extended their participation to 6 (Belgium/Luxembourg, Czech Republic, Greece, India, Italy, Netherlands, Saudi Arabia, South Africa, South Korea, Sweden, Tunisia, and United Kingdom/Ireland) and 12 months (Finland, France, and Japan), respectively.
Study Type
OBSERVATIONAL
Enrollment
51,170
Start dose and frequency to be prescribed by the physician as a result of a normal clinical practice.
Novo Nordisk Investigational Site
Brussels, Belgium
Novo Nordisk Investigational Site
Prague, Czechia
Novo Nordisk Investigational Site
Copenhagen S, Denmark
Novo Nordisk Investigational Site
Espoo, Finland
Novo Nordisk Investigational Site
Paris La Défense Cedex, France
Novo Nordisk Investigational Site
Vouliagment, Greece
Novo Nordisk Investigational Site
Dublin, Ireland
Novo Nordisk Investigational Site
Kfar Saba, Israel
Novo Nordisk Investigational Site
Rome, Italy
Novo Nordisk Investigational Site
Seoul, South Korea
...and 3 more locations
Incidence of Serious Adverse Reactions, Including Major Hypoglycaemic Events
The incidence of serious adverse reactions (SARs), including major hypoglycaemic events, during 3 months of insulin detemir therapy for all countries participating in the study, and during 6 and 12 months of insulin detemir therapy for some of the participating countries. The three sub-groups were mutually exclusive. Physicians did not report all major hypoglycaemic events as SARs. The values in the SAE table are SARs including only those major hypoglycaemic events that were reported as SARs by physicians.
Time frame: Months 0-12
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