Assessing pancreatic cancer risk in type 2 diabetes patients using exenatide versus other medications

EXCEED - 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 is trying to see if using exenatide for type 2 diabetes affects the risk of pancreatic cancer differently than other diabetes medications.

Quick facts

• Study type: Observational
• Enrollment: 24000 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: AstraZeneca (Industry-sponsored)
• Locations: 8 sites (Copenhagen and 7 other locations)
• Trial ID: NCT05663515 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the risk of pancreatic cancer in patients with type 2 diabetes mellitus (T2DM) who have initiated treatment with exenatide compared to those who have started other non-glucagon-like peptide 1 receptor agonists (GLP-1 RAs). Data will be collected from secondary sources across seven European countries, utilizing a multi-country, long-term, retrospective approach. Patients will be matched based on propensity scores and the timing of their treatment initiation, and analyses will be conducted using an intention-to-treat methodology to ensure robust results.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 years or older with a diagnosis of type 2 diabetes who have initiated treatment with exenatide or other non-GLP-1 RA glucose-lowering drugs.

Not a fit: Patients who are not diagnosed with type 2 diabetes or those who have not initiated treatment with exenatide or other specified medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide critical insights into the safety profile of exenatide, potentially influencing treatment decisions for T2DM patients.

How similar studies have performed: While this study addresses a specific safety concern, similar observational studies have previously shown success in assessing medication risks, indicating that this approach is both relevant and necessary.

Eligibility criteria

For inclusion in either exposure group, all of the following inclusion criteria must be fulfilled:

1. Aged 18 years or older at the index date
2. Individual level data on prescriptions, diagnoses and medical history is available for a minimum of 12 months prior to the index date
3. A diagnosis of T2DM on index date or prior to index date

For inclusion in the overall exenatide exposure group, the following criterion must be fulfilled:

1. One incident prescription (or incident dispensed prescription) for exenatide (BYETTA or BYDUREON/ BYDUREON BCise) between the start and 12 months before the end of the study period. This incident prescription must have succeeded a prescription of a GLD of another drug class during the baseline period.

   For inclusion in the BYDUREON/ BYDUREON BCise exposure group, for the analyses of the secondary objective, the criterion a) is substituted with criterion b):
2. One incident prescription (or incident dispensed prescription) for BYDUREON/ BYDUREON BCise between the start and 12 months before the end of the study period. This incident prescription must have succeeded a prescription of a GLD of another drug class during the baseline period.

   For inclusion in the comparator group, the following criterion must be fulfilled:
3. One incident prescription (or incident dispensed prescription) of a GLD between the start and 12 months before the end of the study period. The GLD must not be a DPP-4i, a GLP-1 RA, or a combination with either a DPP-4i or a GLP-1 RA. This incident prescription must have succeeded a prescription of a GLD of another drug class during the baseline period.

Patients are not eligible for any of the study population groups if they fulfil any of the following exclusion criteria:

1. A diagnosis of type 1 diabetes mellitus (T1DM) on index date or a diagnosis of T1DM during the baseline period that is not succeeded by a T2DM diagnosis during the remaining part of the baseline period.
2. A diagnosis of gestational diabetes during the baseline period or on index date.
3. A diagnosis of polycystic ovarian syndrome during the baseline period or on index date in combination with exposure to metformin (Anatomical Therapeutic Chemical Classification System (ATC) code of the World Health Organization (WHO): A10BA02) as the only GLD on index date or during the baseline period.
4. History of any cancer on or prior to index date. The only exception is that nonmelanoma skin cancer does not lead to exclusion.
5. History of any acute pancreatitis, other diseases of the pancreas, or disorders of the pancreas on or prior to index date.
6. One or more prescriptions (or dispensed prescriptions) of a GLP-1 RA (incretin mimetics) other than exenatide on or prior to index date.
7. One or more prescriptions (or dispensed prescriptions) of DPP-4i (incretin mimetics) on or prior to the index date.

Where this trial is running

Copenhagen and 7 other locations

• Research Site — Copenhagen, Denmark (Recruiting)
• Research Site — Helsinki, Finland (Recruiting)
• Research Site — Paris, France (Recruiting)
• Research Site — Bergen, Norway (Recruiting)
• Research Site — Barcelona, Spain (Recruiting)
• Research Site — Vänersborg, Sweden (Recruiting)
• Research Site — Edinburgh, United Kingdom (Recruiting)
• Research Site — London, United Kingdom (Recruiting)

Study contacts

• Principal investigator: Fabian Hoti, PhD — IQVIA Pty Ltd
• Study coordinator: AstraZeneca Clinical Study Information Center

Conditions Pancreatic Cancer