- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04572165
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
December 29, 2023 updated by: Novo Nordisk A/S
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 Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
600000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Odense, Denmark, 5000
- Novo Nordisk Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
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.
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
semaglutide
New users of Ozempic® or Rybelsus®
|
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.
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.
|
Active comparator
First-time ever users of an active comparator drug
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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From when semaglutide entered the market in Denmark, Sweden, and Norway (Q3/Q4 2018) until December 31, 2023
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Clinical Transparency (1452), Novo Nordisk A/S
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 26, 2021
Primary Completion (Estimated)
December 31, 2024
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
September 30, 2020
First Submitted That Met QC Criteria
September 30, 2020
First Posted (Actual)
October 1, 2020
Study Record Updates
Last Update Posted (Estimated)
January 1, 2024
Last Update Submitted That Met QC Criteria
December 29, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NN9535-4447
- U1111-1214-6228 (Other Identifier: World Health Organization (WHO))
- EUPAS37258 (Registry Identifier: EU PAS Register)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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