A Pan-European Post-Authorisation Safety Study: Risk of Pancreatic Cancer Among Type 2 Diabetes Patients who Initiated Exenatide as Compared with those who Initiated Other non-Glucagon-Like Peptide 1 Receptor Agonists based Glucose Lowering Drugs (EXCEED)

Study type

• Study topic:
  Human medicinal product
• 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

• 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

  Pancreatic carcinoma

Population studied

• 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:
  350000

Study design details

• Main study objective:
  To estimate the incidence rate and hazard ratio for pancreatic cancer associated with exposure to exenatide (BYETTA or BYDUREON/ BYDUREON BCise), compared with exposure to non-Glucagon Like Peptide-1 Receptor Agonist based Glucose Lowering Drugs, among patients with Type 2 Diabetes Mellitus.
• Outcomes:
  Pancreatic cancer
• Data analysis plan:
  The incidence rate of pancreatic cancer will be estimated for the exenatide group and the comparator group in each of the 8 data sources. For the analysis of the primary objective, Cox proportional hazards regression will be used to estimate the hazard ratio (with 95% confidence interval) for time to pancreatic cancer, comparing patients in the exenatide group to the comparator group by the ‘intention-to-treat” approach. In secondary analysis of the primary objective, the association between cumulative use of exenatide and pancreatic cancer will also be assessed. The analyses will be conducted for each data source separately and combined using meta-analyses, providing a summary estimate for all data sources.