Comparison of the Risk of Cancer Between Patients With Type 2 Diabetes Exposed to Dapagliflozin and Those Exposed to Other Antidiabetic Treatments

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/49352
• EU PAS number:
  EUPAS12116
• Study ID:
  49352
• Official title and acronym:
  Comparison of the Risk of Cancer Between Patients With Type 2 Diabetes Exposed to Dapagliflozin and Those Exposed to Other Antidiabetic Treatments
• DARWIN EU® study:
  No
• Study countries:
  Netherlands

  United Kingdom

  United States
• Study description:
  This is a multinational cohort database study to estimate the incidence of female breast cancer and bladder cancer, by insulin use at cohort entry, in patients who are prescribed dapagliflozin compared to patients prescribed other specific oral antidiabetic drugs. ; Dapagliflozin and other antidiabetic drugs are used to treat type 2 diabetes mellitus. ; Because of the mechanism of action for dapagliflozin and results from small safety monitoring studies, there is interest in further evaluating the safety of dapagliflozin in a large populations.; The study will be implemented in four administrative health care data sources in three countries: in the United Kingdom, the Clinical Practice Research Datalink (CPRD), in the United States, the Centers for Medicare and Medicaid Services (CMS) Medicare databases and the Healthcare Integrated Research Database (HIRD), and, in the Netherlands, the PHARMO Database Network. ; Individuals in the databases will be included in the study if they meet the following age criteria, 40 years or older (CPRD and PHARMO), 40 to 64 years (HIRD) or 65 years or older (Medicare), and if they did not have type 1 diabetes, were treated with one of the study drugs and meet the criteria of at least 180 days of electronic data before their first prescription of the study drug. ; The study period starts November 13, 2012 in CPRD, November 1, 2013 in PHARMO and January 9, 2014 in the United States data sources, and will end at the latest available data at each database at the time of analysis.
• Study status:
  Ongoing

Research institutions and networks

Institutions

RTI Health Solutions (RTI-HS)

France

Spain

Sweden

United Kingdom

United Kingdom (Northern Ireland)

United States

HealthCore

The PHARMO Institute for Drug Outcomes Research (PHARMO Institute)

Netherlands

Study timelines

Date when funding contract was signed

Planned: 12/02/2015

Actual: 12/02/2015

Study start date

Planned: 29/01/2016

Actual: 01/02/2016

Date of interim report, if expected

Planned: 30/12/2016

Actual: 22/11/2016

Date of final study report

Planned: 31/12/2025

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Astra Zeneca

Study protocol

Initial protocol

DAPA Protocol MB102118_Cancer_ 27June 2014_final_redacted

Updated protocol

Dapa Cancer Protocol MB102118__v3.1_06Jun2023_final_signed_Redacted

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

NCT02695121

Link to Clinicaltrials.gov