PRJ2335: An Observational Study of the Risk of Acute Pancreatitis in Subjects Exposed to Albiglutide, Other GLP-1 Agonists and DPP-4 Inhibitors Compared to Other Antidiabetic Agents

Trial description: The role of glucagon-like peptide-1 (GLP-1) agonists in type 2 diabetes (T2D) treatment is still evolving and a number of GLP-1 agonists are newly marketed (e.g., albiglutide and lixisenatide) or in the pipeline (e.g., dulaglutide and semaglutide). There have been some safety concerns raised about the risk of acute pancreatitis due to the use of GLP-1 agonists and dipeptidyl peptidase-4 (DPP4) inhibitor therapies. This study addresses an important safety question for the incretin mimetic class of antidiabetic agents in general and for albiglutide in particular. This will be a retrospective cohort study conducted in the Truven Marketscan Commercial (formerly, Thomson Reuters) health insurance database once a minimum of 5,000 Type 2 diabetic subjects exposed to albiglutide in this database have accrued. This analysis will be repeated once 31,000 subjects are exposed to albiglutide in this database. The study will be conducted to evaluate the association between albiglutide and acute pancreatitis as compared to the association observed between this outcome and use of other ADAs (excluding GLP-1 agonists and DPP-4 inhibitors); and to evaluate the association between GLP-1 agonists (including and excluding albiglutide), DPP-4 inhibitors and acute pancreatitis as compared to the association observed between this outcome and use of other ADAs.Subject will be followed in the study from the index date (first prescription for the new ADA in the study period) until the first occurrence of acute pancreatitis, loss of pharmacy benefits, disenrollment from the database, turning 65 years old, discontinuation of the index medication, switching of the study medication groups, or end of follow-up in the database, whichever comes earlier.