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

Sponsor
Boehringer Ingelheim
Study ID
NCT03817463
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

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

Key Dates

Start date
Apr 15, 2019
Status verified
May 2024
Primary completion
Dec 10, 2021
Completion
Dec 10, 2021

Study Design

Enrollment
327,624 participants (actual)

Arms

  • Arm: New users of SGLT-2i
    Patients with type 2 diabetes mellitus (T2DM), who were new users of any sodium-glucose cotransporter-2 inhibitors (SGLT-2i) including empagliflozin.
  • Arm: New users of DPP-4i
    Patients with type 2 diabetes mellitus (T2DM), who were new users of dipeptidyl peptidase-4 inhibitors (DPP-4i).

Primary Outcome Measure

Number of Participants With Hospitalization for Heart Failure (HHF), Broad + Specific Definition [ Time Frame: From index date until end of follow-up, up to 67 months for matched cohort of empagliflozin/DPP-4i. Up to 86 months for matched cohort of SGLT-2i/DPP-4i ]

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