Antidiabetic Medications and Risk of Cancer

A retrospective analysis was conducted based on data of the National Health Insurance Fund in Hungary. Overall cancer risk and site-specific cancer risks were analysed in a target trial emulation design when comparing all available antidiabetic therapies to MET and monotherapies and primary combination therapies against each other. The model used in the analysis was corrected for age, gender, co-morbidities, selected cardiovascular medications and inpatient and outpatient visits.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Drug: Metformin; Drug: sulphonylurea; Drug: DPP-4 inhibitor; Drug: GLP-1 Receptor Agonists; Drug: SGLT-2 inhibitor; Drug: insulin; Drug: MET + SU; Drug: MET + DPP-4 inhibitor; Drug: MET + GLP-1RA; Drug: MET + SGLT2i; Drug: MET + INS

• Study Type: Observational
• Enrollment (Actual): 74799

Contacts and Locations

Study Locations

• Hungary
  • Pécs, Hungary, 7634
    • Pécs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The source population consisted of all individuals aged ≥19 years on 1 January 2016 who had no inpatient or outpatient care for malignant disease between 2009 and 2015 and no antidiabetic drug dispensing between 2011-2015.

The primary study population included individuals from this source population who dispensed any antidiabetic medication between 2016 and 2022.

Description

Inclusion Criteria:

• Type 2 diabetes mellitus
• Antidiabetic medication initiators

Exclusion Criteria:

• Antidiabetic prescription in the previous 5 years
• Recent pancreatectomy (previous or subsequent 90 days after inclusion)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Type 2 diabetes mellitus

Drug: Metformin; Metformin monotherapy; Drug: sulphonylurea; SU monotherapy; Drug: DPP-4 inhibitor; DPP-4 inhibitor monotherapy; Drug: GLP-1 Receptor Agonists; GLP-1 Receptor Agonist monotherapy; Drug: SGLT-2 inhibitor; SGLT-2 inhibitor monotherapy; Drug: insulin; Insulin monotherapy; Drug: MET + SU; MET + SU combination; Drug: MET + DPP-4 inhibitor; MET + DPP-4 inhibitor combination; Drug: MET + GLP-1RA; MET + GLP-1RA combination; Drug: MET + SGLT2i; MET + SGLT2i combination; Drug: MET + INS; MET + insulin combination

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall cancer risk	2016-2022

Other Outcome Measures

Outcome Measure	Time Frame
Risk of lung cancer	2016-2022
Risk of colorectal cancer	2016-2022
Risk of pancreas cancer	2016-2022
Risk of urinary cancer	2016-2022
Risk of breast cancer	2016-2022
Risk of prostate cancer	2016-2022
Risk of hematological cancer	2016-2022
Risk of upper GI cancer	2016-2022
Risk of liver cancer	2016-2022
Risk of ovarian cancer	2016-2022
Risk of other types of cancer	2016-2022

Collaborators and Investigators

• Sponsor: University of Pecs
• Investigators: Study Chair: György Rokszin, M.D., Ph.D.

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2025
• Primary Completion (Actual): December 30, 2025
• Study Completion (Actual): December 30, 2025

Study Registration Dates

• First Submitted: May 31, 2026
• First Submitted That Met QC Criteria: May 31, 2026
• First Posted (Actual): June 5, 2026

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: May 31, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Type 2 diabetes mellitus; Antidiabetic agents; risk of cancer
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Neoplasms; Diabetes Mellitus, Type 2; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hypoglycemic Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Enzyme Inhibitors; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Sulfur Compounds; Organic Chemicals; Pharmacologic Actions; Chemical Actions and Uses; Amides; Biguanides; Guanidines; Amidines; Sulfones; Insulins; Pancreatic Hormones; Urea; Proinsulin; Sodium-Glucose Transporter 2 Inhibitors; Glucagon-Like Peptide-1 Receptor Agonists; Metformin; Insulin; Dipeptidyl-Peptidase IV Inhibitors; Sulfonylurea Compounds; desaminopancreozymin octapeptide
• Other Study ID Numbers: PTE Antidiab_cc_2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Because of data security reasons, individual-level data are not available to the researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes