Characteristics of Empagliflozin Initiators
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About
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 type 2 diabetes mellitus (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.
Full description
Study Design:
cross sectional
Enrollment
Sex
Volunteers
Inclusion criteria
All patients will be required to meet all of the following criteria:
- At least 12 months of continuous registration prior to the index date in a practice contributing up to standard (UTS) data to the Clinical Practice Research Datalink (CPRD). Infants younger than 1 year will not be required to have 12 months of continuous UTS registration in the CPRD.
- A new user of one of the index prescriptions (empagliflozin, other SGLT2 inhibitor, or non-insulin GLDs) or a fixed dose combination (FDC) with metformin.
Exclusion criteria
There is no exclusion criterion in this study.
Trial design
31,908 participants in 3 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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