A cohort study to investigate the risk of severe hypoglycemia among diabetic patients treated with Lyumjev® using the Medical Data Vision (MDV) database in Japan (I8B-JE-B003)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  LYUMJEV
• Medical condition to be studied:
  Hypoglycaemia

Population studied

• Age groups:
  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  5190

Study design details

• Main study objective:
  The primary objective is to describe the incidence proportion and incidence rate of first severe hypoglycemia requiring any hospital visit among: • Adult patients (?18-years-old) with diabetes treated with Lyumjev under routine care
• Outcomes:
  severe hypoglycemia
• Data analysis plan:
  Incidence proportion of first severe hypoglycemia (n/N, %) will be calculated. Incidence rate and its 95% CI of the first severe hypoglycemia requiring any hospital visit among the Lyumjev treated cohort will be calculated as the number events per 100 person-years.