Characteristics of patients initiating empagliflozin or other non-insulin glucose lowering drugs in the United Kingdom

Date of Approval
Application Number
16_138
Technical Summary

Empagliflozin, a sodium glucose cotransporter 2 (SGLT-2) inhibitor, was launched in the UK in August 2014.
It can be expected that patients initiating empagliflozin may differ in their characteristics from patients initiating other GLDs that have been longer on the market (e.g., patients may have poorer glucose control). In agreement with the European Medicines Agency (EMA), Boehringer Ingelheim (BI) has committed to conduct this drug utilization study (DUS) to assess the characteristics of patients initiating empagliflozin in terms of baseline characteristics, concomitant medications, and comorbidities compared to patients initiating other SGLT-2 inhibitors or other non-insulin GLDs.
In addition, as some patients taking empagliflozin included in the clinical trials have experienced weight loss in the empagliflozin arm due to its mode of action, a theoretical possibility exists that empagliflozin may be used by patients without the current approved indication. Therefore, this study also aims to assess the potential off-label use of empagliflozin compared to other non-insulin GLDs.

Health Outcomes to be Measured

General baseline characteristics of patients with (or without) a recorded diagnosis of T2DM starting empagliflozin (other SGLT-2 inhibitors or non-insulin GLDs) in the UK between August 2014 and September 2015.

Collaborators

Kimberly Brodovicz - Chief Investigator - Boehringer-Ingelheim Pharmaceuticals, Inc
Soulmaz Fazeli Farsani - Corresponding Applicant - Boehringer-Ingelheim International GmbH
Christina Raabe - Collaborator - Boehringer-Ingelheim International GmbH
Cynthia Girman - Collaborator - Merck & Co. Inc - Pennsylvania, USA
Jyothis Thomas George - Collaborator - Boehringer-Ingelheim Pharmaceuticals, Inc
Patrice Verpillat - Collaborator - Merck Healthcare KGaA (Merck Group)
William Henry Fitzgerald Spencer - Collaborator - Boehringer-Ingelheim Pharmaceuticals, Inc