Actively Recruiting
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
Led by AstraZeneca · Updated on 2026-05-05
24000
Participants Needed
8
Research Sites
104 weeks
Total Duration
On this page
Sponsors
A
AstraZeneca
Lead Sponsor
I
IQVIA Pvt. Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older at the index date
- Available individual data on prescriptions, diagnoses, and medical history for at least 12 months before the index date
- Diagnosis of type 2 diabetes mellitus on or before the index date
- For exenatide group: One first-time prescription for exenatide during the study period, following a previous glucose-lowering drug prescription
- For BYDUREON/BYDUREON BCise group: One first-time prescription for BYDUREON/BYDUREON BCise during the study period, following a previous glucose-lowering drug prescription
- For comparator group: One first-time prescription for a glucose-lowering drug that is not DPP-4i or GLP-1 RA during the study period, following a previous glucose-lowering drug prescription
You will not qualify if you...
- Diagnosis of type 1 diabetes mellitus on or before the index date without a later diagnosis of type 2 diabetes mellitus
- Diagnosis of gestational diabetes on or before the index date
- Diagnosis of polycystic ovarian syndrome during baseline or on index date combined with metformin as the only glucose-lowering drug
- History of any cancer on or before the index date, except nonmelanoma skin cancer
- History of any acute pancreatitis or other pancreatic diseases on or before the index date
- Any prescriptions for GLP-1 RA drugs other than exenatide on or before the index date
- Any prescriptions for DPP-4i drugs on or before the index date
AI-Screening
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Trial Site Locations
Total: 8 locations
1
Research Site
Copenhagen, Denmark
Actively Recruiting
2
Research Site
Helsinki, Finland
Actively Recruiting
3
Research Site
Paris, France
Actively Recruiting
4
Research Site
Bergen, Norway
Actively Recruiting
5
Research Site
Barcelona, Spain
Actively Recruiting
6
Research Site
Vänersborg, Sweden
Actively Recruiting
7
Research Site
Edinburgh, United Kingdom
Actively Recruiting
8
Research Site
London, United Kingdom
Actively Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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