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 HealthCore Integrated Research Database (HIRDSM), 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 institution and networks

Institutions

RTI Health Solutions (RTI-HS)
France
Spain
Sweden
United Kingdom
United Kingdom (Northern Ireland)
United States
First published:
19/02/2024
Institution
Not-for-profitENCePP partner
HealthCore
First published:
01/02/2024
Institution

Contact details

Lia Gutierrez

Primary lead investigator
ORCID number:
0000-0001-6280-1119
Study timelines

Date when funding contract was signed

Planned:
Actual:

Data collection

Planned:
Actual:

Date of interim report, if expected

Planned:
Actual:

Date of final study report

Planned:
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

English (852.94 KB - PDF)View document
Updated protocol

Dapa Cancer Protocol MB102118__v3.1_06Jun2023_final_signed_Redacted

English (6.69 MB - PDF)View document
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)