Comparison of Canagliflozin vs. Alternative Antihyperglycemic Treatments on Risk of Below Knee Lower Extremity Amputation for Patients with Type 2 Diabetes Mellitus and the Subpopulation with Established Cardiovascular Disease

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/34314
• EU PAS number:
  EUPAS27670
• Study ID:
  34314
• Official title and acronym:
  Comparison of Canagliflozin vs. Alternative Antihyperglycemic Treatments on Risk of Below Knee Lower Extremity Amputation for Patients with Type 2 Diabetes Mellitus and the Subpopulation with Established Cardiovascular Disease
• 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: 18/12/2018

Actual: 18/12/2018

Study start date

Planned: 09/01/2019

Actual: 09/01/2019

Date of final study report

Planned: 24/07/2019

Actual: 15/07/2019

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)