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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

This study, called EXCEED, is looking into whether there's a higher chance of developing pancreatic cancer for people with type 2 diabetes who start taking a medicine called exenatide. To do this, researchers are comparing their health records with those of people who started other types of diabetes medicines that work differently. The study is using existing health information from seven European countries, including the UK, covering patients aged 18 and over, treated between 2006 and 2023. By carefully comparing these groups, scientists hope to understand more about the safety of exenatide regarding pancreatic cancer.

At a glance

Status
Recruiting
Sponsor
AstraZeneca
Enrolment target
24,000
Start
30 Sep 2024
Estimated completion
01 Oct 2026

What is this study about?

Imagine you have type 2 diabetes, and your doctor prescribes a new medicine. Before any medicine is widely used, it goes through many tests. But even after it's approved, scientists keep a close eye on how it affects people in the real world. This study, called EXCEED, is one of those important follow-up checks.

The main goal of EXCEED is to see if there's any difference in the risk of developing pancreatic cancer for people with type 2 diabetes who started taking a specific medicine called exenatide, compared to those who started other common diabetes medicines that don't belong to the same group as exenatide. It's like comparing two groups of people to see if one group has a slightly higher chance of a particular health issue.

Researchers are using existing health records from hospitals and clinics across seven European countries, including the UK. This allows them to look back at many years of patient information (from 2006 to 2023) to understand any potential links between these medicines and pancreatic cancer. This type of study helps doctors and patients make the safest choices for managing diabetes.

Key takeaways

  • The EXCEED study is looking at exenatide, a type 2 diabetes medicine.
  • It aims to see if exenatide is linked to a higher risk of pancreatic cancer.
  • Researchers are comparing exenatide users with users of other diabetes drugs.
  • The study uses existing health records from seven European countries.
  • It's a look-back study, so it won't change your current medical care.
  • The goal is to provide important information on medicine safety.

Who may be eligible?

To be included in this study, you would need to be 18 years old or older. You must also have been diagnosed with type 2 diabetes at some point around the time you started your diabetes medication, and have at least a year's worth of health records available before that date.

Specifically, for the exenatide group, you would have started taking exenatide (either BYETTA or BYDUREON/BYDUREON BCise) for the first time during the study period (2006-2023). For the comparison group, you would have started a different type of diabetes medicine that is not from the GLP-1 RA group (like exenatide) or DPP-4i group, and not a combination with those, for the first time during the same period.

You would not be included if you have type 1 diabetes or have a history of gestational diabetes.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Do you have type 2 diabetes?
  3. Did you start a new diabetes medicine (either exenatide or another specific type) between 2006 and 2023?
  4. Do you have at least a year of health records available before starting that medicine?
  5. Have you never been diagnosed with type 1 diabetes?
Answer every question to see your result.

What does participation involve?

This study does not involve you doing anything new or different. You won't have any extra doctor's visits, assessments, or medications to take. Researchers are simply looking at existing, anonymised health records from the past. This means your personal information isn't directly used; instead, researchers look at large sets of data to spot patterns.

Therefore, there's no direct participation needed from you. Your health information, alongside many others, helps contribute to this important research. The study uses information collected between 2006 and 2023.

Potential risks and benefits

Since this study only uses existing, anonymised health records, there are no direct risks to individuals involved. You won't experience any changes to your medical care or privacy. The potential benefit is that the study could provide important information about the long-term safety of diabetes medications, helping doctors and patients make more informed treatment decisions in the future. Because you are not directly participating, there is no 'right to withdraw' in the traditional sense, as your anonymised data has already been collected as part of routine care.

Locations (8)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Research Site
    Verified postcode
    Copenhagen, Denmark· Recruiting
  • Research Site
    Verified postcode
    Helsinki, Finland· Recruiting
  • Research Site
    Verified postcode
    Paris, France· Recruiting
  • Research Site
    Verified postcode
    Bergen, Norway· Recruiting
  • Research Site
    Verified postcode
    Barcelona, Spain· Recruiting
  • Research Site
    Verified postcode
    Vänersborg, Sweden· Recruiting
  • Research Site
    Verified postcode
    Edinburgh, United Kingdom· Recruiting
  • Research Site
    Verified postcode
    London, United Kingdom· Recruiting

Common questions

What is exenatide?

Exenatide is a medicine used to help people with type 2 diabetes control their blood sugar levels.

What is pancreatic cancer?

Pancreatic cancer is a serious type of cancer that starts in the pancreas, an organ behind your stomach.

Will this study affect my diabetes treatment?

No, this study will not affect your current or future diabetes treatment. It just looks at past health records.

Is my personal information safe?

Yes, researchers use anonymised health records, meaning your name and direct identifiers are removed to protect your privacy.

What does a 'post-authorisation safety study' mean?

It means the study is happening after a medicine like exenatide has already been approved for use, to keep checking its safety in many people over time.

How to find out more

AstraZeneca Clinical Study Information Center

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A Pan-European Post-Authorisation Safety Study: Risk of Panc…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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