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
- Conditions
- Pancreatic Cancer
- Interventions
- Drug: Non-GLP-1 RA based glucose lowering drugs
- Registration Number
- NCT05663515
- Lead Sponsor
- AstraZeneca
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 24000
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Initiators of non-GLP-1 RA based glucose lowering drugs Non-GLP-1 RA based glucose lowering drugs Patients with T2DM, aged 18 years or older, who initiated treatment with non-GLP-1 RA based glucose lowering drugs during the study period, 2006 to 2023 Initiators of exenatide Exenatide Patients with T2DM, aged 18 years or older, who initiated treatment with exenatide during the study period, 2006 to 2023
- Primary Outcome Measures
Name Time Method 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 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.
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 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Research Site
🇬🇧London, United Kingdom