Non-interventional study on the effectiveness and safety of Empagliflozin compared with DPP-4 inhibitors in patients with type 2 diabetes in the United States

Study identification

• EU PAS number:
  EUPAS20677
• Study ID:
  21657
• Official title and acronym:
  Non-interventional study on the effectiveness and safety of Empagliflozin compared with DPP-4 inhibitors in patients with type 2 diabetes in the United States
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The main objective of the proposed study is to compare selected CV effectiveness outcomes in patients with T2DM initiating empagliflozin compared to propensity score (PS) matched patients with T2DM initiating a DPP-4 inhibitor in sequential analyses within periodically updated cohorts in the U.S., secondary objectives include other effectiveness outcomes, safety outcomes, and healthcare utilization outcomes.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Brigham and Women's Hospital

Study timelines

Date when funding contract was signed

Planned:01/12/2016

Study start date

Planned:15/10/2017

Actual:15/10/2017

Data analysis start date

Planned:15/10/2017

Actual:15/10/2017

Date of final study report

Planned:31/03/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim

Regulatory

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