Risk Factors Associated with Severe Hypoglycemia Among Patients with Type 2 Diabetes Mellitus Treated with Insulin (Risk factors for severe hypoglycemia)

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:
  Case-control

Study drug and medical condition

• Medical condition to be studied:
  Insulin-requiring type 2 diabetes mellitus

  Hypoglycaemia

Population studied

• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  10000

Study design details

• Main study objective:
  To identify risk factors for severe hypoglycemic (SH) events in insulin-treated T2DM patients.
• Outcomes:
  Severe hypoglycemia
• Data analysis plan:
  For the primary and secondary objectives, a retrospective nested case-control study with incidence density sampling utilizing adjudicated healthcare administrative claims data will be used to identify risk factors of SH based on demographic and clinical characteristics in insulin-treated T2DM patients. Descriptive statistics will be reported using frequency and percentage distributions for categorical variables. Mean, median, and standard deviation will be generated as measures of central tendency and variance for continuous and count variables. Conditional logistic regression will be used to identify potential risk factors for SH after matching. Forward or backward variable selection procedures may be used to determine which variables to include in the final model.