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
Recruiting now
Conditions studied: Pancreatic Cancer
In brief
EXCEED is a non-interventional post-authorisation safety study aiming to assess the risk of developing pancreatic cancer among type 2 diabetes mellitus (T2DM) patients who initiated exenatide compared to those who initiated other non-glucagon like peptide 1 receptor agonists (GLP-1 RA) based glucose lowering drugs (GLDs). Study data will be collected from secondary data sources across 7 European countries. The study will be conducted as a multi-country, long-term, retrospective, observational database study. Initiators of exenatide will be matched to initiators of non-GLP-1 RA based GLDs (comparator group) based on propensity score and calendar period of study entry. All analyses for pancreatic cancer will be conducted in the matched study population using an "intention-to-treat" approach. The study will use information from 8 data sources in 7 European countries (France, Spain, The United Kingdom, Finland, Denmark, Norway, and Sweden). Patients with T2DM, aged 18 years or older, who initiated treatment with exenatide or non-GLP-1 RA based GLDs during the study period, 2006 to 2023, will be included. Exposure to exenatide and non-GLP-1 RA based GLDs will be ascertained from recordings of prescriptions or insurance claims registrations as available in the different data sources. The outcome of pancreatic cancer will be defined as a primary diagnosis of pancreatic cancer during follow-up
Key facts
- Study ID
- NCT05663515
- Run by
- AstraZeneca
- People needed
- 24000
- Starts
- 2024-09-30
- Expected to finish
- 2026-10-01
- Last updated by the study team
- 2026-08-04
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Research Site — Copenhagen, Denmark (enrolling)
- Research Site — Helsinki, Finland (enrolling)
- Research Site — Paris, France (enrolling)
- Research Site — Bergen, Norway (enrolling)
- Research Site — Barcelona, Spain (enrolling)
- Research Site — Vänersborg, Sweden (enrolling)
- Research Site — Edinburgh, United Kingdom (enrolling)
- Research Site — London, United Kingdom (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.