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A Study to Observe the Effectiveness of Empagliflozin, Other SGLT-2 Inhibitors, or DPP-4 Inhibitors in Patients With Type 2 Diabetes

Boehringer Ingelheim logo

Boehringer Ingelheim

Status

Completed

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: Subjects treated with Dipeptidyl peptidase-4 (DPP-4) inhibitor
Drug: Subjects treated with Empagliflozin or any Sodium-glucose cotransporter-2 (SGLT-2) inhibitor

Study type

Observational

Funder types

Industry

Identifiers

NCT03817463
1245-0195

Details and patient eligibility

About

Non-interventional, multi-country cohort study using existing data and including adults (≥18 years) with a diagnosis of Type 2 diabetes mellitus.

Enrollment

327,624 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Dispensation or any other record of empagliflozin, any SGLT-2 inhibitor, or any DPP-4 inhibitor use during the study period
  • No dispensation or any other record of any other SGLT-2 inhibitor or DPP-4 inhibitor use during the preceding 12 months including at index date
  • Having a diagnosis of T2DM before the index date, based on ICD-10 codes or other available data

Exclusion criteria

  • Aged <18 years on the first dispensation date or date of the first record of empagliflozin, any SGLT-2 inhibitor or any DPP-4 inhibitor use
  • Type 1 diabetes mellitus
  • Secondary diabetes
  • Gestational diabetes
  • Having a diagnosis of ESRD during the 12 months before the index date
  • <12 months of available data before the index date, and/or no complete history of drug dispensations/other records of the drug use during this period
  • Missing or ambiguous data on age or sex

Trial design

327,624 participants in 2 patient groups

New users of SGLT-2i
Description:
Patients with type 2 diabetes mellitus (T2DM), who were new users of any sodium-glucose cotransporter-2 inhibitors (SGLT-2i) including empagliflozin.
Treatment:
Drug: Subjects treated with Empagliflozin or any Sodium-glucose cotransporter-2 (SGLT-2) inhibitor
New users of DPP-4i
Description:
Patients with type 2 diabetes mellitus (T2DM), who were new users of dipeptidyl peptidase-4 inhibitors (DPP-4i).
Treatment:
Drug: Subjects treated with Dipeptidyl peptidase-4 (DPP-4) inhibitor

Trial documents
2

Trial contacts and locations

13

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Data sourced from clinicaltrials.gov

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