Incidence of Diabetic Ketoacidosis among Patients with Type 2 Diabetes Mellitus Treated with SGLT2 inhibitors or Other Antihyperglycemic Agents- A Retrospective, Observational, New-User Cohort Study Using an Administrative Claims Database in the US

Study identification

• EU PAS number:
  EUPAS20065
• Study ID:
  20195
• Official title and acronym:
  Incidence of Diabetic Ketoacidosis among Patients with Type 2 Diabetes Mellitus Treated with SGLT2 inhibitors or Other Antihyperglycemic Agents- A Retrospective, Observational, New-User Cohort Study Using an Administrative Claims Database in the US
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study status:
  Finalised

Research institutions and networks

Institutions

NA (database study)

Study timelines

Date when funding contract was signed

Planned:01/06/2015

Actual:01/06/2015

Study start date

Planned:25/06/2015

Actual:25/06/2015

Date of final study report

Planned:31/03/2017

Actual:31/03/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Janssen Research & Development, LLC

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)