The effect of SGLT2 inhibitors among patients with Type 2 diabetes on the incidence of colorectal cancer

Study identification

• EU PAS number:
  EUPAS1000000920
• Study ID:
  1000000920
• Official title and acronym:
  The effect of SGLT2 inhibitors among patients with Type 2 diabetes on the incidence of colorectal cancer
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  The diabetes medication class of SGLT2 inhibitors (SGLT2i) has been shown to not only improve glycaemic control in type 2 diabetes patients, but also provide cardiovascular benefit in both diabetic patients and patients with heart failure, as well as renal benefit. Recent nonclinical research results have additionally suggested a potential benefit in reducing colorectal tumour growth. A retrospective cohort study from Hong Kong has supported this claim by estimating a reduced risk of incident colorectal cancer (CRC) for SGLT2i users compared to DPP4 inhibitor (DPP4i) users. Two Asian multi-outcome database studies suggest a similar protective effect.; ; This study aims to estimate the causal effect of initiating treatment with SGLT2i versus DPP4i additionally to metformin therapy in persons with type 2 diabetes. It is designed as a cohort study based on German health insurance claims data from the years 2009 – 2023; targeted maximum likelihood estimation for survival & competing risk analysis will be used to estimate absolute CRC-specific risk curves for both treatment groups and 5-year average treatment effects will be estimated.;
• Study status:
  Planned

Research institutions and networks

Institutions

Pharmacoepidemiology Research, Federal Institute for Drugs and Medical Devices (BfArM)

Germany

Study timelines

Date when funding contract was signed

Planned:05/11/2022

Actual:11/11/2022

Study start date

Planned:30/04/2026

Date of final study report

Planned:31/10/2026

Sources of funding

EU institutional research programme

More details on funding

HORIZON Europe

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable