Characteristics of patients initiating empagliflozin or other non-insulin glucose lowering drugs in the United Kingdom (Empa DUS in UK)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/20835
• EU PAS number:
  EUPAS14507
• Study ID:
  20835
• Official title and acronym:
  Characteristics of patients initiating empagliflozin or other non-insulin glucose lowering drugs in the United Kingdom (Empa DUS in UK)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  Empagliflozin, a sodium glucose cotransporter 2 (SGLT-2) inhibitor, was launched in the United Kingdom (UK) in August 2014. It can be expected that patients initiating empagliflozin may differ in their characteristics from patients initiating other glucose lowering drugs (GLDs) that have been on the market longer (e.g. patients may have poorer glucose control). Therefore, the proposed study aims to characterize patients with T2DM in the UK initiating empagliflozin in terms of baseline characteristics, concomitant medications, and comorbidities compared to patients with T2DM initiating other SGLT-2 inhibitors or other non-insulin GLDs. Due to the mode of action, some patients taking empagliflozin have experienced weight loss in clinical trials. A theoretical possibility exists that empagliflozin may be used by patients without T2DM. Therefore, this study also aims to assess the potential off-label use of empagliflozin compared to other non-insulin GLDs.
• Study status:
  Finalised

Research institutions and networks

Institutions

Boehringer Ingelheim

Study timelines

Date when funding contract was signed

Planned: 09/10/2015

Actual: 09/10/2015

Study start date

Planned: 01/09/2016

Actual: 10/09/2016

Data analysis start date

Planned: 01/09/2016

Actual: 10/09/2016

Date of final study report

Planned: 30/11/2016

Actual: 04/11/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim GmbH

Study protocol

Initial protocol

1245-0122-protocol-2016-08-11_Version 2.0_highlighted_geschwärzt

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)