Diabetes Mellitus, Type 2NCT04572165
Epidemiological Assessment of the Risk for Pancreatic Cancer Associated With the Use of Semaglutide in Patients With Type 2 Diabetes - A Cohort Study Based on Nordic Registry Data
An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Denmark.
Trial summary
The aim of this study is to evaluate whether exposure to semaglutide influences the risk of pancreatic cancer in patients with type 2 diabetes. This is achieved by estimating the risk of pancreatic cancer associated with semaglutide use as compared to use of other non-incretin antidiabetic drugs used at a similar… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Ozempic®, Active Comparator and Rybelsus®
- How many people
- 194,928 participants
- Where
- 1 siteDenmark
- Study dates
- 26 Jan 2021to 25 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to evaluate whether exposure to semaglutide influences the risk of pancreatic cancer in patients with type 2 diabetes. This is achieved by estimating the risk of pancreatic cancer associated with semaglutide use as compared to use of other non-incretin antidiabetic drugs used at a similar stage as Ozempic® or Rybelsus® in the treatment of type 2 diabetes. A multi-national, non-interventional study based on health care data from Denmark, Sweden, and Norway is conducted covering the period 2018-2023. A cohort study design is used comparing new users of semaglutide with new users of other antidiabetic drugs used at a similar stage as Ozempic® or Rybelsus® in the treatment of type 2 diabetes (active comparators). Active comparators will include the following non-incretin antidiabetic agents: sulphonylureas, sodium-glucose co-transporter 2 inhibitors, and insulin subdivided into i) basal insulin only and ii) basal + bolus insulin or premix insulin. Propensity scores are used to match new users of semaglutide with new users of active comparators. National prescription-, cancer- and patient registries are used to identify exposure to antidiabetic agents, pancreatic cancer cases, and covariates to be used in propensity score matching. This study is a post-authorisation safety study (PASS).
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Ozempic®, Active Comparator, Rybelsus®
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ozempic®Drug
Patients have been treated with commercially available Ozempic® according to local label and to routine clinical practice at the discretion of the treating physician. The decision to initiate treatment with commercially available Ozempic® had been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on local label before and independently from the decision to include the patient in this study.
Active ComparatorDrug
Patients have been treated with commercially available active comparators according to local label and to routine clinical practice at the discretion of the treating physician. Active comparators will include the following antidiabetic agents: sulphonylureas, sodium-glucose co-transporter 2 inhibitors, and insulin. The decision to initiate treatment with commercially available active comparators had been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on local label before and independently from the decision to include the patient in this study.
Rybelsus®Drug
Patients have been treated with commercially available Rybelsus® according to local label and to routine clinical practice at the discretion of the treating physician. The decision to initiate treatment with commercially available Rybelsus® had been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on local label before and independently from the decision to include the patient in this study.
| Study group | Role | What they receive |
|---|---|---|
| semaglutide | New users of Ozempic® or Rybelsus® Receives: Drug: Ozempic®; Drug: Rybelsus® | |
| Active comparator | First-time ever users of an active comparator drug Receives: Drug: Active Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of first time malignant neoplasm of pancreas
Incidence
Measured: From when semaglutide entered the market in Denmark, Sweden, and Norway (Q3/Q4 2018) until December 31, 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start26 Jan 2021
- Primary completion25 Nov 2025
- Study completion25 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 194,928 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Southern Denmark
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04572165
- Sponsor's protocol ID
- NN9535-4447
- Other IDs
- U1111-1214-6228, EUPAS37258
- Status last verified
- Jun 2026
- First submitted
- 30 Sep 2020
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Assessment of the Risk for Pancreatic Cancer Associated With the Use of Semaglutide in Patients With Type 2 Diabetes - A Cohort Study Based on Nordic Registry Data
- ClinicalTrials.gov ID
- NCT04572165
- Acronym / sponsor ID
- NN9535-4447
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 194,928 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Collaborators
- University of Southern Denmark
- Study start
- 26 Jan 2021 (actual)
- Primary completion
- 25 Nov 2025 (actual)
- Study completion
- 25 Nov 2025 (actual)
- First posted
- 1 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate whether exposure to semaglutide influences the risk of pancreatic cancer in patients with type 2 diabetes. This is achieved by estimating the risk of pancreatic cancer associated with semaglutide use as compared to use of other non-incretin antidiabetic drugs used at a similar stage as Ozempic® or Rybelsus® in the treatment of type 2 diabetes. A multi-national, non-interventional study based on health care data from Denmark, Sweden, and Norway is conducted covering the period 2018-2023. A cohort study design is used comparing new users of semaglutide with new users of other antidiabetic drugs used at a similar stage as Ozempic® or Rybelsus® in the treatment of type 2 diabetes (active comparators). Active comparators will include the following non-incretin antidiabetic agents: sulphonylureas, sodium-glucose co-transporter 2 inhibitors, and insulin subdivided into i) basal insulin only and ii) basal + bolus insulin or premix insulin. Propensity scores are used to match new users of semaglutide with new users of active comparators. National prescription-, cancer- and patient registries are used to identify exposure to antidiabetic agents, pancreatic cancer cases, and covariates to be used in propensity score matching. This study is a post-authorisation safety study (PASS).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| semaglutide | – | Drug: Ozempic®, Drug: Rybelsus®New users of Ozempic® or Rybelsus® |
| Active comparator | – | Drug: Active ComparatorFirst-time ever users of an active comparator drug |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ozempic®Patients have been treated with commercially available Ozempic® according to local label and to routine clinical practice at the discretion of the treating physician. The decision to initiate treatment with commercially available Ozempic® had been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on local label before and independently from the decision to include the patient in this study. | Drug | semaglutide |
| Active ComparatorPatients have been treated with commercially available active comparators according to local label and to routine clinical practice at the discretion of the treating physician. Active comparators will include the following antidiabetic agents: sulphonylureas, sodium-glucose co-transporter 2 inhibitors, and insulin. The decision to initiate treatment with commercially available active comparators had been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on local label before and independently from the decision to include the patient in this study. | Drug | Active comparator |
| Rybelsus®Patients have been treated with commercially available Rybelsus® according to local label and to routine clinical practice at the discretion of the treating physician. The decision to initiate treatment with commercially available Rybelsus® had been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on local label before and independently from the decision to include the patient in this study. | Drug | semaglutide |
Primary outcome
Occurrence of first time malignant neoplasm of pancreas
Time frame: From when semaglutide entered the market in Denmark, Sweden, and Norway (Q3/Q4 2018) until December 31, 2023
Incidence
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Transparency (1452) study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of first time malignant neoplasm of pancreas (time frame: From when semaglutide entered the market in Denmark, Sweden, and Norway (Q3/Q4 2018) until December 31, 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.