Evaluating Comparative Effectiveness of Empagliflozin in Type 2 Diabetes Population With and Without Chronic Kidney Disease

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Boehringer Ingelheim
Study ID
NCT05465317
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Empagliflozin — DRUG
    Empagliflozin
  • Dipeptidyl Peptidate-4 inhibitors — DRUG
    Dipeptidyl Peptidate-4 inhibitors

Study Details

The primary purpose of this research study is to determine the cardiovascular and renal effectiveness and safety of empagliflozin compared to dipeptidyl peptidase-4 inhibitors (DPP4i) in patients with Type 2 Diabetes Mellitus (T2DM) with and without established kidney disease. The secondary purpose of this research study is to determine the cardiovascular and renal effectiveness and safety of any Sodium glucose co-transporter-2 inhibitors (SGLT2i) compared to Glucagon-like Peptide-1 Receptor Agonists (GLP1RA) in patients with T2DM.

Key Dates

Start date
Aug 8, 2022
Status verified
Apr 2024
Primary completion
May 2, 2023
Completion
May 2, 2023

Study Design

Enrollment
62,197 participants (actual)

Arms

  • Arm: Empagliflozin initiators
    Patient with type 2 diabetes, with or without Chronic Kidney Disease (CKD), who initiated Empagliflozin between January 1, 2016 and December 31, 2020.
  • Arm: Dipeptidyl peptidate-4 inhibitor (DPP4i) initiators
    Patient with type 2 diabetes, with or without Chronic Kidney Disease (CKD), who initiated dipeptidyl peptidate-4 inhibitor (DPP4i) between January 1, 2016 and December 31, 2020.

Primary Outcome Measure

Incidence Rate of the Composite Outcome Including 40% Decline in Estimated Glomerular Filtration Rate (eGFR), Incident End-stage Renal Disease (ESRD) and All-cause Death [ Time Frame: Starting the day after the index date (date of initiation of empagliflozin or DPP4i) and continuing until the first occurrence of the outcome of interest, or end of study date (date of death, date of study end, 2 years after index date). Up to 2 years. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Duke Clinical Research InstituteDurhamNorth Carolina27707-

Find similar trials in Durham, NC

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Duke Clinical Research Institute· Durham, NC

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