Clinical Outcomes and Healthcare Cost and Resource Utilization (HCRU) in Patients With Type 2 Diabetes and Cardiovascular Disease on 2nd Line Empagliflozin Versus 2nd Line Sulfonylureas

Part of paid clinical trials in Ridgefield, Connecticut.

Sponsor
Boehringer Ingelheim
Study ID
NCT05102071
Status
Withdrawn

Conditions

Eligibility Criteria

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

Interventions

  • empagliflozin — DRUG
    empagliflozin
  • metformin — DRUG
    metformin
  • sulfonylurea — DRUG
    sulfonylurea

Study Details

Evaluation of clinical outcomes (specifically cardiovascular outcomes like hospitalization for heart failure), and healthcare cost, and resource utilization, among patients on empagliflozin as an add-on therapy to metformin versus patients on sulfonylureas as an add-on therapy to metformin in patients with Type 2 Diabetes (T2D) and Cardiovascular Disease (CVD).

Key Dates

Start date
Nov 1, 2021
Status verified
May 2022
Primary completion
Jun 15, 2022
Completion
Jun 15, 2022

Study Design

Enrollment
0 participants (actual)

Arms

  • Arm: Treatment with empagliflozin
    as add-on therapy with metformin
  • Arm: Treatment with a sulfonylurea
    as add-on therapy with metformin

Primary Outcome Measure

Occurrence of first hospitalization for congestive heart failure (HHF) [ Time Frame: up to 5 years and 3 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Boehringer Ingelheim Pharmaceuticals IncRidgefieldConnecticut06879-

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