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

BYDUREON

Study drug International non-proprietary name (INN) or common name

EXENATIDE

Medical condition to be studied

Type 2 diabetes mellitus
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

55000
Study design details

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.

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.