Characteristics of Empagliflozin Initiators

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

31908 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-10

Study Completion Date

2016-10-14

Brief Summary

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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.

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Detailed Description

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Study Design:

cross sectional

Conditions

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Type 2 Diabetes

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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New users of Empagliflozin

New users of empagliflozin

Empagliflozin

Intervention Type DRUG

New users of Other SGLT2 inhibitors

New users of other SGLT2 inhibitors

Other SGLT2 inhibitors

Intervention Type DRUG

New users of Other non-insulin GLDs

New users of other non-insulin GLDs

Other non-insulin GLDs

Intervention Type DRUG

metformin, sulfonylureas, DPP-4 inhibitors, GLP-1 agonists

Interventions

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Empagliflozin

Intervention Type DRUG

Other SGLT2 inhibitors

Intervention Type DRUG

Other non-insulin GLDs

metformin, sulfonylureas, DPP-4 inhibitors, GLP-1 agonists

Intervention Type DRUG

Eligibility Criteria

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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.