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

Date of Approval: 
2016-07-20 00:00:00
Lay Summary: 
Empagliflozin (the brand name in the United Kingdom is Jardiance) is a new medicine to treat type 2 diabetes in adults. In this study, routinely collected health information from the Clinical Practice Research Datalink will be used to identify patients who started using empagliflozin and other diabetes treatments. The demographic and medical characteristics of patients who started empagliflozin will be compared with the characteristics of patients who started other diabetes medicines. This assessment will be used to describe how patients starting empagliflozin are similar or different from patients starting other diabetes treatments. Understanding these similarities and differences can help in the interpretation of the benefits and risks of empagliflozin and other diabetes treatments and can provide information to guide future healthcare decision-making to control blood sugar in patient with diabetes.
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.
Application Number: 
16_138
Collaborators: 

Kimberly Brodovicz, - Chief Investigator - Boehringer-Ingelheim International GmbH
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