Lung Cancer Risk in Type 2 Diabetes With COPD: SGLT2 Inhibitors vs. Sulfonylureas

NCT07332156 | Completed

• 1 other identifier: SU vs. SGLT2 in T2DM with COPD
• Study Type: observational
• Target: 21,692
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this observational study is to learn if a specific diabetes medicine can lower the risk of lung cancer in people with type 2 diabetes and chronic obstructive pulmonary disease (COPD). The main question it aims to answer is: \- Does taking medicines called SGLT2 inhibitors lower the chance of getting lung cancer compared to medicines called sulfonylureas? Researchers will compare the medical records of people taking SGLT2 inhibitors to those taking sulfonylureas to see if the SGLT2 group has fewer cases of lung cancer. Participants will not need to visit a doctor or take new medicines for this study. Researchers will use information from existing medical records to answer the research question.

Conditions

Type 2 Diabetes; COPD (Chronic Obstructive Pulmonary Disease); Lung Cancer (Diagnosis)

Keywords

SGLT2 inhibitor; Sulfonylurea; T2DM with COPD; Lung cancer

Outcome Measures

Primary Outcomes (1)

• Lung cancer

  ICD-10 code (C33 or C34) and code for special purposes (V193)

  From index date + 30 days to the end of follow-up

Secondary Outcomes (2)

• COPD exacerbation

  From index date + 30 days to the end of follow-up

• Any cancer

  From index date + 30 days to the end of follow-up

Study Arms (6)

Treatment group (main)

Users of SGLT2 inhibitors (for ITT analysis)

Drug: SGLT2 inhibitor

Active control group (main)

Users of sulfonylureas for ITT analysis

Drug: Sulfonylureas (SU)

Treatment group (S1)

Users of SGLT2 inhibitors (for ITT analysis)

Drug: SGLT2 inhibitor

Active control group (S1)

Users of DPP4 inhibitors (for ITT analysis)

Drug: Sulfonylureas (SU)

Treatment group (S2)

Users of SGLT2 inhibitors (for as-treated analysis)

Drug: SGLT2 inhibitor

Active control group (S2)

Users of sulfonylureas (for as-treated analysis)

Drug: DPP4 inhibitors

Interventions

SGLT2 inhibitor DRUG

Any new prescription of SGLT2 inhibitors after new onset of T2DM

Treatment group (S1); Treatment group (S2); Treatment group (main)

Sulfonylureas (SU) DRUG

Any new prescription of sulfonylureas after new onset of T2DM

Active control group (S1); Active control group (main)

DPP4 inhibitors DRUG

Any new prescription of DPP4 inhibitors after new onset of T2DM

Active control group (S2)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study included adults aged ≥40 years with a prior history of COPD (screened from 2009) and newly diagnosed type 2 diabetes who initiated treatment with either sulfonylureas or SGLT2 inhibitors between January 1, 2014, and December 31, 2023. Type 2 diabetes was defined as having two or more diagnosis records within one year using ICD-10 codes E10-E14. COPD was defined by the presence of ICD-10 codes J43 or J44 (excluding J43.0) concurrent with the prescription of COPD medications at least twice within a year; these medications included long-acting muscarinic antagonists (LAMA), long-acting beta-2 agonists (LABA), ICS plus LABA, short-acting muscarinic antagonists (SAMA), short-acting beta-2 agonists (SABA), SAMA plus SABA, methylxanthines, and systemic beta agonists. In the sensitivity analysis, we are planning to substitute sulfonylurea to DPP4 inhibitors.

You may qualify if:

• Adults aged ≥40 years with prior COPD (from 2009) and newly diagnosed diabetes who initiated SU or SGLT2i between January 1, 2014 and December 31, 2023

You may not qualify if:

• Pre-existing
• ESRD
• Cancer
• Concurrent prescribing of the study drugs at the index date
• Exposure to the drugs of interest during the year preceding the index date
• Death or cancer incidence within a month
• In the sensitivity analysis, we are planning to substitute sulfonylurea to DPP4 inhibitors.

Sponsors & Collaborators

• Samsung Medical Center: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Pulmonary Disease, Chronic Obstructive; Lung Neoplasms; Disease

Interventions

Sodium-Glucose Transporter 2 Inhibitors; Sulfonylurea Compounds; Dipeptidyl-Peptidase IV Inhibitors

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs; Urea; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Protease Inhibitors; Enzyme Inhibitors

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 28, 2025
• First Posted: January 12, 2026
• Study Start: January 1, 2009
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share