NCT07628556

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74,799

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 5, 2026

Completed
Last Updated

June 5, 2026

Status Verified

May 1, 2026

Enrollment Period

10 months

First QC Date

May 31, 2026

Last Update Submit

May 31, 2026

Conditions

Cancer

Keywords

Antidiabetic agentsrisk of cancerType 2 diabetes mellitus

Outcome Measures

Primary Outcomes (1)

  • Overall cancer risk

    2016-2022

Other Outcomes (11)

  • Risk of lung cancer

    2016-2022

  • Risk of colorectal cancer

    2016-2022

  • Risk of pancreas cancer

    2016-2022

  • +8 more other outcomes

Study Arms (1)

Type 2 diabetes mellitus

Drug: MetforminDrug: sulphonylureaDrug: DPP-4 inhibitorDrug: GLP-1 Receptor AgonistsDrug: SGLT-2 inhibitorDrug: insulinDrug: MET + SUDrug: MET + DPP-4 inhibitorDrug: MET + GLP-1RADrug: MET + SGLT2iDrug: MET + INS

Interventions

MetforminDRUG

Metformin monotherapy

Type 2 diabetes mellitus
sulphonylureaDRUG

SU monotherapy

Type 2 diabetes mellitus
DPP-4 inhibitorDRUG

DPP-4 inhibitor monotherapy

Type 2 diabetes mellitus
GLP-1 Receptor AgonistsDRUG

GLP-1 Receptor Agonist monotherapy

Type 2 diabetes mellitus
SGLT-2 inhibitorDRUG

SGLT-2 inhibitor monotherapy

Type 2 diabetes mellitus
insulinDRUG

Insulin monotherapy

Type 2 diabetes mellitus
MET + SUDRUG

MET + SU combination

Type 2 diabetes mellitus
MET + DPP-4 inhibitorDRUG

MET + DPP-4 inhibitor combination

Type 2 diabetes mellitus
MET + GLP-1RADRUG

MET + GLP-1RA combination

Type 2 diabetes mellitus
MET + SGLT2iDRUG

MET + SGLT2i combination

Type 2 diabetes mellitus
MET + INSDRUG

MET + insulin combination

Type 2 diabetes mellitus

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Type 2 diabetes mellitus
  • Antidiabetic medication initiators

You may not qualify if:

  • Antidiabetic prescription in the previous 5 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pécs

Pécs, 7634, Hungary

Location

MeSH Terms

Conditions

NeoplasmsDiabetes Mellitus, Type 2

Interventions

MetforminSulfonylurea CompoundsDipeptidyl-Peptidase IV InhibitorsGlucagon-Like Peptide-1 Receptor AgonistsSodium-Glucose Transporter 2 InhibitorsInsulindesaminopancreozymin octapeptide

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsUreaAmidesSulfonesSulfur CompoundsProtease InhibitorsEnzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesHypoglycemic AgentsPhysiological Effects of DrugsProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • György Rokszin, M.D., Ph.D.

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full professor

Study Record Dates

First Submitted

May 31, 2026

First Posted

June 5, 2026

Study Start

March 15, 2025

Primary Completion

December 30, 2025

Study Completion

December 30, 2025

Last Updated

June 5, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Because of data security reasons, individual-level data are not available to the researchers

Locations

HU(1)