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 4 Administrative Claims Databases in the US

Study identification

• EU PAS number:
  EUPAS23705
• Study ID:
  34362
• 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 4 Administrative Claims Databases in the US
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study status:
  Finalised

Research institutions and networks

Institutions

Johnson & Johnson

Study timelines

Date when funding contract was signed

Planned:18/04/2018

Actual:18/04/2018

Study start date

Planned:18/04/2018

Actual:18/04/2018

Date of final study report

Planned:08/10/2018

Actual:01/10/2018

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