Incidence of Thyroid Neoplasm and Pancreatic Cancer in Type 2 Diabetes Mellitus Patients who Initiate Once Weekly Exenatide Compared with Other Antihyperglycemic Drugs

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  BYDUREON
• Study drug International non-proprietary name (INN) or common name:
  EXENATIDE
• Anatomical Therapeutic Chemical (ATC) code:
  (A10BJ01) exenatide

  exenatide
• Medical condition to be studied:
  Type 2 diabetes mellitus

  Thyroid neoplasm

  Pancreatic carcinoma

Population studied

• Short description of the study population:
  The study cohort will consist of adults aged 18 years and older with a diagnosis of diabetes mellitus as recorded in the medical record. Patients with a record of type I diabetes will be excluded.
• Age groups:
  • 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:
  55000

Study design details

• Study design:
  Retrospective cohort study
• Main study objective:
  The objective of this study is to estimate and compare the incidence of thyroid neoplasm and pancreatic cancer among initiators of exenatide once weekly compared with users of other oral antidiabetic agents.
• Comparators:
  Users of other oral antidiabetic agents
• Outcomes:
  Incidence of thyroid neoplasm and pancreatic cancer. To describe the incidence of medullary thyroid cancer (MTC) among initiators of exenatide once weekly and matched control cohort of other anti-diabetic drugs.To estimate the incidence of new-onset benign thyroid neoplasm among initiators of exenatide once weekly compared to a matched control cohort of other anti-diabetic drugs.
• Data analysis plan:
  Risk of cancers in relation to the exposure to exenatide once weekly will be estimated in terms of incidence and relative risk as compared with exposure to other anti-diabetic treatment. Patients will be matched based on their baseline characteristics. Intent-to-treat analysis will be performed using Cox regression analysis. Time-dependent analysis will be additionally conducted based on current and past exposure to the study drugs.