Comparison of the Risk of Acute Liver Injury 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/50493
• EU PAS number:
  EUPAS12110
• Study ID:
  50493
• Official title and acronym:
  Comparison of the Risk of Acute Liver Injury Between Patients With Type 2 Diabetes Exposed to Dapagliflozin and Those Exposed to Other Antidiabetic Treatments
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom

  United States
• Study description:
  The overall goal of this research study is to estimate the risk of hospitalization for acute liver injury 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 large populations. The study will be implemented in three administrative health care data sources in two countries: in the United Kingdom, the Clinical Practice Research Datalink (CPRD), and in the United States, the Centers for Medicare and Medicaid Services (CMS) Medicare databases and the HealthCore Integrated Research Database (HIRDSM). Individuals in the databases will be included in the study if they meet the following age criteria, 18 years and older (CPRD and HIRD), or 65 years or older (Medicare), and if they did not have type 1 diabetes, are new users of 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 July 1, 2013 in CPRD 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:
  Finalised

Research institutions and networks

Institutions

RTI Health Solutions (RTI-HS)

France

Spain

Sweden

United Kingdom

United Kingdom (Northern Ireland)

United States

RTI Health Solutions (RTI-HS)

France

Spain

Sweden

United Kingdom

United Kingdom (Northern Ireland)

United States

Healthcore United States

Study timelines

Date when funding contract was signed

Planned: 12/02/2015

Actual: 12/02/2015

Study start date

Planned: 29/01/2016

Actual: 02/02/2016

Date of interim report, if expected

Planned: 30/12/2016

Actual: 22/11/2016

Date of final study report

Planned: 30/11/2020

Actual: 23/12/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Astra Zeneca

Study protocol

Initial protocol

DAPA ALI Protocol_ final 23 June 2014_redacted

Updated protocol

DAPA ALI_Protocol_Revisions 28Feb2017_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

D1690R00005