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.
Study Type
OBSERVATIONAL
Enrollment
24,000
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.
Initiators of non-GLP-1 RA based GLDs with no use of exenatide before or during the study period.
Research Site
Copenhagen, Denmark
RECRUITINGResearch Site
Helsinki, Finland
RECRUITINGResearch Site
Paris, France
RECRUITINGResearch Site
Bergen, Norway
RECRUITINGResearch Site
Barcelona, Spain
RECRUITINGResearch Site
Vänersborg, Sweden
RECRUITINGResearch Site
Edinburgh, United Kingdom
RECRUITINGResearch Site
London, United Kingdom
RECRUITINGIncidence rate of primary diagnosis of pancreatic cancer among exenatide exposed population
To estimate the incidence rate (IR) for pancreatic cancer associated with exposure to exenatide, compared with exposure to non-GLP-1 RA based GLDs, among patients with T2DM.
Time frame: 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
To estimate the hazard ratio (HR) for pancreatic cancer associated with exposure to exenatide, compared with exposure to non-GLP-1 RA based GLDs, among patients with T2DM.
Time frame: Follow-up starts from thr index date to the study completion, an average of 1.5 years or less
AstraZeneca Clinical Study Information Center
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