SGLT2 Inhibitors and the Risk of Hospitalization for Fournier’s Gangrene: a Nested Case-control Study (MK-8835-067)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/30437
• EU PAS number:
  EUPAS28953
• Study ID:
  30437
• Official title and acronym:
  SGLT2 Inhibitors and the Risk of Hospitalization for Fournier’s Gangrene: a Nested Case-control Study (MK-8835-067)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The proposed study is a nested case-control study that will be conducted within a population-based cohort from the Truven Health MarketScan™ databases. The cohort will include patients 18 years of age or older who are prescribed at least one antihyperglycemic agent between April 1, 2013 (when the first sodium-glucose cotransporter 2 (SGLT2) inhibitor was available in the United States) and March 31, 2018 (latest available data). A nested case-control analysis will be carried out to provide the relative risks of Fournier's gangrene with SGLT2 inhibitors compared to other non-SGLT2 inhibitor antihyperglycemic agents (AHAs) in a real-world setting.
• Study status:
  Finalised

Research institutions and networks

Institutions

Merck & Co.

Study timelines

Date when funding contract was signed

Actual: 10/10/2018

Study start date

Planned: 15/04/2019

Actual: 15/04/2019

Data analysis start date

Planned: 20/05/2019

Actual: 23/05/2019

Date of final study report

Planned: 28/06/2019

Actual: 27/06/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck Sharp & Dohme, Corp.

Regulatory

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

Other study registration identification numbers and links

VEAP ID NO: 8347EPIDEMIOLOGY NO.: EP02039.006