Characteristics of Empagliflozin Initiators

Sponsor
Boehringer Ingelheim
Study ID
NCT03050619
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin — DRUG
  • Other SGLT2 inhibitors — DRUG
  • Other non-insulin GLDs — DRUG
    metformin, sulfonylureas, DPP-4 inhibitors, GLP-1 agonists

Study Details

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.

Key Dates

Start date
Sep 10, 2016
Status verified
Aug 2018
Primary completion
Oct 14, 2016
Completion
Oct 14, 2016

Study Design

Enrollment
31,908 participants (actual)

Arms

  • Arm: New users of Empagliflozin
    New users of empagliflozin
  • Arm: New users of Other SGLT2 inhibitors
    New users of other SGLT2 inhibitors
  • Arm: New users of Other non-insulin GLDs
    New users of other non-insulin GLDs

Primary Outcome Measure

Baseline Characteristics of Adults (as Measured by Demographics) With a Recorded Diagnosis of T2DM Starting Index Prescriptions in the UK [ Time Frame: Baseline ]

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