Acute Effect of Empagliflozin vs Dapagliflozin Over Pulse Wave Velocity in Type Two Diabetes

Sponsor
Centro Universitario de Ciencias de la Salud, Mexico
Study ID
NCT05109949
Phase
PHASE3
Status
Unknown

Conditions

  • Diabetes Mellitus Type 2 Without Complication

Eligibility Criteria

Sex
ALL
Age
40 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin 10Mg Tab — DRUG
    Daily morning dose per oral of Dapagliflozin 10 mg for 7 days
  • Empagliflozin 25 MG — DRUG
    Daily morning dose per oral of Empagliflozine 25 mg for 7 days
  • Placebo — OTHER
    Daily morning dose per oral of Calcined magnesite 500 mg for 7 days

Study Details

To date one of the main independent biomarkers of cardiovascular disease is the arterial stiffness parameters measured by carotid-femoral pulse wave velocity. It is known that SGLT2 inhibitors develop cardiac protection over long term administration, but there's not enough studies about acute effects in early administration.

Key Dates

Start date
Mar 30, 2020
Status verified
Nov 2021
Primary completion
Jun 1, 2022
Completion
Aug 1, 2022

Study Design

Enrollment
72 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Dapagliflozin 10 mg
    Dapagliflozin is an oral medication used to treat Type 2 diabetes. It belongs to a sodium-glucose cotransporter 2 (SGLT2) inhibitors.
  • Experimental: Empagliflozin 25 mg
    Empagliflozin is an oral medication used to treat Type 2 diabetes. It belongs to sodium-glucose cotransporter 2 (SGLT2) inhibitors.
  • Placebo Comparator: Placebo
    Calcinated magnesium is a white powdery compound, MgO, used in pharmaceuticals as binder.

Primary Outcome Measure

Pulse wave velocity [ Time Frame: 7 days ]