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 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…
Conditions studied
Pancreatic Cancer
About this study
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
Interventions
- Drug: Exenatide — All patients initiating exenatide during the study period will be identified by ATC codes and be included in the exenatide group in a hierarchical manner, regardless of previous use of non-GLP-1 RA based glucose lowering drugs.
- Drug: Non-GLP-1 RA based glucose lowering drugs — Initiators of non-GLP-1 RA based GLDs with no use of exenatide before or during the study period.
Primary outcomes
- Incidence rate of primary diagnosis of pancreatic cancer among exenatide exposed population (Follow-up starts from the index date to the study completion, an average of 1.5 years or less)
- Hazard ratio of primary diagnosis of pancreatic cancer among exenatide exposed population (Follow-up starts from thr index date to the study completion, an average of 1.5 years or less)
Eligibility information
Study locations
- Research Site, Copenhagen, Denmark
- Research Site, Helsinki, Finland
- Research Site, Paris, France
- Research Site, Bergen, Norway
- Research Site, Barcelona, Spain
- Research Site, Vänersborg, Sweden
- Research Site, Edinburgh, United Kingdom
- Research Site, London, United Kingdom
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-28.