Massive study investigates cancer risk of popular diabetes drug
NCT ID NCT04572165
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study analyzed health records from nearly 195,000 people in Denmark, Sweden, and Norway to see if semaglutide (the drug in Ozempic and Rybelsus) is linked to a higher risk of pancreatic cancer. Researchers compared new users of semaglutide to new users of other diabetes medications. The goal was to gather safety information, not to test a new treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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194,928 people
The number who actually took part.
- Started
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Jan 2021
- Finished
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Nov 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The risk of pancreatic cancer is compared in a cohort of first-time ever users of semaglutide relative to a cohort of first-time ever users of the other antidiabetic drugs used at a similar stage as Ozempic® or Rybelsus® in the treatment of type 2 diabetes.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Use of semaglutide or initiation of active comparators from when the first subject is dispensed semaglutide in the respective country (2018) until December 31, 2022. Initiation is defined as no previous prescription of a drug with the same active ingredient in the past 10 years as recorded in the national prescription registries. Previous use of the same class of drug is however accepted. Further, a patient who shift from Ozempic® to Rybelsus® or vice versa will be considered a continued user in the semaglutide group. * At least two prescriptions of either semaglutide or active comparators (at the level of the active ingredient) with the second prescription filled less than one year after the initial prescription. Two prescriptions filled at first day of treatment will, however, only be counted as one prescription. * 18 years or older at the cohort entry date. The cohort entry date is defined as the dispensing date of the initial prescription (i.e. treatment initiation). * Ten years or more of continuous residency in the country of residence before initiation of semaglutide or active comparators. Exclusion Criteria: Patients with rare but strong risk factors for developing pancreatic cancer are excluded. Therefore, patients with any history of the following conditions (identified according to 10th version of International Classification of Diseases \[ICD-10\]) before cohort entry date (based on the last 10 years of data or more) are excluded: * A history of any cancer except non-melanoma skin cancer * Acute pancreatitis * Alcohol-induced chronic pancreatitis * Other chronic pancreatitis * Cystic fibrosis * Other phacomatoses, not elsewhere classified (including Peutz-Jeghers syndrome and Von Hippel-Lindau syndrome) * Neurofibromatosis (non-malignant, Von Recklinghausen disease) In addition, the following patients are excluded: * Patients with a history of pancreatic cancer as these patients are no longer at risk for an incident pancreatic cancer * Patients who initially started insulin as first-line antidiabetic treatment and who did not add on or switch to non-insulin treatment within 3 months. Those initiating insulin as first-line treatment during the study period is disregarded in terms of study inclusion, although they may be included upon initiating additional therapy, provided it is started within three months. * Patients with polycystic ovary syndrome (PCOS) * Patients with gestational diabetes * Patients who meet one of the conditions used as exclusion criteria listed above (except acute and chronic pancreatitis) after cohort entry date but before start of follow-up (i.e. during the first year after treatment initiation)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Southern Denmark
Odense, 5000, Denmark
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Other studies related to the condition(s) this trial covers.
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