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

Plain English Summary

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 is a Not Applicable clinical trial sponsored by AstraZeneca studying Pancreatic Cancer. This study examines if a diabetes medication called exenatide is linked to a higher risk of pancreatic cancer in people with type 2 diabetes. It is for adults aged 18 and older diagnosed with type 2 diabetes who are starting or have started treatment with exenatide or other non-GLP-1 RA diabetes drugs. Participation involves reviewing existing health records from 7 European countries; no new treatments or visits are required. Alternatives include other classes of diabetes medications not involving GLP-1 receptor agonists. The trial aims to enroll 24000 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you are 18 or older, have type 2 diabetes, and have at least 12 months of prior health data. You cannot join if you have a history of any cancer (except non-melanoma skin cancer), pancreatitis, or other pancreatic diseases. You also cannot join if you have previously used other GLP-1 receptor agonists (besides exenatide) or DPP-4 inhibitors. Gestational diabetes or type 1 diabetes also exclude participation. This trial is studying Pancreatic Cancer, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures will tell us if patients taking exenatide are more or less likely to be diagnosed with pancreatic cancer compared to those on other diabetes drugs. The specific primary outcome measures are: 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); 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). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This study is important because it investigates a potential safety concern for a widely used diabetes medication, aiming to fill a gap in understanding its long-term effects on pancreatic health. This research targets Pancreatic Cancer, where improved treatment options are needed.

Investor Insight

This observational study by AstraZeneca aims to provide crucial safety data for exenatide, a drug in the large and competitive diabetes market, potentially influencing its future use and regulatory st The large enrollment target of 24000 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor about the specific diabetes medications you are taking and any potential risks associated with them. Participation is passive, relying on existing medical records, so your day-to-day routine will not change. Ensure your healthcare providers have accurate records of your medical history and prescriptions. This trial is currently recruiting participants. The trial is being conducted at 8 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: OBSERVATIONAL
• Enrollment: 24,000 participants

Interventions

• DRUG: Exenatide — 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.
• DRUG: 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.

Primary Outcomes

• 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)
• 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)

Full 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.

Trial Locations

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

Frequently Asked Questions

Related Conditions

• Type 2 Diabetes Mellitus
• Pancreatic Cancer
• Diabetes Management
• Endocrine Disorders
• Gastrointestinal Cancers
• Drug Safety
• Pharmacovigilance
• Metabolic Syndrome
• Cardiovascular Risk in Diabetes
• Obesity

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