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

Study Overview

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

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).

N/A

Diabetes Mellitus, Type 2

DRUG: Ozempic®
DRUG: Active Comparator
DRUG: Rybelsus®

NN9535-4447
U1111-1214-6228 (OTHER Identifier) (OTHER: World Health Organization (WHO))
EUPAS37258 (REGISTRY Identifier) (REGISTRY: EU PAS Register)

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2020-09-30	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2023-12-29
First Submitted that Met QC Criteria 2020-09-30	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-01-02
First Posted (ACTUAL) 2020-10-01	Results First Posted N/A	Last Verified 2023-12

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: semaglutide New users of Ozempic® or Rybelsus®	DRUG: 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 DRUG: 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
: Active comparator First-time ever users of an active comparator drug	DRUG: Active Comparator 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: sulphonylur

Participant Group/Arm

Intervention/Treatment

: semaglutide

New users of Ozempic® or Rybelsus®

DRUG: 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

DRUG: 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

: Active comparator

First-time ever users of an active comparator drug

DRUG: Active Comparator

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: sulphonylur

Primary Outcome Measures	Measure Description	Time Frame
Occurrence of first time malignant neoplasm of pancreas	Incidence	From when semaglutide entered the market in Denmark, Sweden, and Norway (Q3/Q4 2018) until December 31, 2023

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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)

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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Department of Public Health, University of Southern Denmark

Investigators

STUDY_DIRECTOR: Clinical Transparency (1452), Novo Nordisk A/S

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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