Clinical and economic impact of 2nd line initiation of empagliflozin after metformin, as compared to 2nd line initiation of sulfonylurea after metformin in patients with type 2 diabetes and cardiovascular disease

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/47812
• EU PAS number:
  EUPAS43815
• Study ID:
  47812
• Official title and acronym:
  Clinical and economic impact of 2nd line initiation of empagliflozin after metformin, as compared to 2nd line initiation of sulfonylurea after metformin in patients with type 2 diabetes and cardiovascular disease
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  Status - finalized This study has been cancelled due to feasibility – did not attain sample size.
• Study status:
  Finalised

Study timelines

Date when funding contract was signed

Planned: 01/07/2021

Actual: 02/07/2021

Study start date

Planned: 30/10/2021

Actual: 01/11/2021

Date of final study report

Planned: 15/07/2022

Actual: 17/06/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim

Study protocol

Initial protocol

Empagliflozin vs Sulfonylureas (Protocol) V3 (002)

Regulatory

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