Post-authorization safety study (PASS) to assess the risk of acute pancreatitis in type 2 diabetes mellitus (T2DM) patients newly initiating empagliflozin compared to other oral non-incretin/non-sodium glucose co-transporter-2 inhibitors (SGLT2)-containing glucose lowering agents

Study identification

• EU PAS number:
  EUPAS44267
• Study ID:
  49733
• Official title and acronym:
  Post-authorization safety study (PASS) to assess the risk of acute pancreatitis in type 2 diabetes mellitus (T2DM) patients newly initiating empagliflozin compared to other oral non-incretin/non-sodium glucose co-transporter-2 inhibitors (SGLT2)-containing glucose lowering agents
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  Empagliflozin is an oral hypoglycaemic agent belonging to the sodium glucose co-transporter-2 inhibitor (SGLT2i) class, which promotes renal excretion of glucose and lowers elevated blood glucose levels in patients with T2DM. Pancreatitis is defined as an important potential risk in the risk management plan (RMP) for empagliflozin. This post-authorization safety study (PASS) is voluntarily performed to assess the risk of acute pancreatitis in patients with T2DM newly initiating empagliflozin compared to the initiators of other oral non-incretin/non-SGLT2i–based hypoglycaemic agents. Studies have shown that the risk of acute pancreatitis is higher in patients with T2DM and established cardiovascular disease (eCVD) than those without these disorders. In the past ten years, numerous studies assessed the association between pancreatitis and hypoglycaemic agents in the United States (US), Canada, United Kingdom (UK), Denmark, and in Asia. Certain diabetes drug classes, for instance incretin-containing medications (including dipeptidyl peptidase 4 inhibitors (DPP-4i, such as sitagliptin, saxagliptin, linagliptin, alogliptin) and glucagon-like peptide-1 receptor agonists (GLP-1 RA, such as exenatide, liraglutide, lixisenatide, dulaglutide, semaglutide)), have been associated with the risk of developing acute pancreatitis. Results have varied from protective to null associations to 2-3-fold elevated risk of acute pancreatitis depending on the design, population, treatments and comparators studied. A voluntary PASS was designed to investigate the risk of acute pancreatitis in new users of empagliflozin compared to the new users of other oral non-incretin/non-SGLT2i-containing hypoglycaemic agents. Comparison groups in this study are selected based on clinical guideline recommendations and current real-world patterns of use for oral hypoglycaemic agents.
• Study status:
  Finalised

Study timelines

Date when funding contract was signed

Planned:12/10/2018

Actual:12/10/2018

Study start date

Planned:20/12/2021

Actual:20/12/2021

Date of final study report

Planned:31/01/2023

Actual:20/02/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim International GmbH

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable