Dapagliflozin vs Empagliflozin on Flow Mediated Dilation in Type 2 Diabetes Mellitus

Sponsor
Centro Universitario de Ciencias de la Salud, Mexico
Study ID
NCT04195243
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Dapagliflozin Pill — DRUG
    The patient will take one pill, every 24 hr, during 7 days
  • Empagliflozin Pill — DRUG
    The patient will take one pill, every 24 hr, during 7 days
  • Placebo pill — DRUG
    The patient will take one pill, every 24 hr, during 7 days

Study Details

Type 2 diabetes mellitus (T2DM) is a considered one of the main global health challenges; the vascular endothelium plays an important role in vascular dysfunction in DM; Hyperglycemia induced by it is recognized as the main factor for the development of vascular complications of the disease, secondary to a reduction in nitric oxide production; "flow-mediated dilation" is the most commonly used technique for the evaluation of endothelial function, being the non-invasive method most widely used. It has been reported that with the use of SGLT2 inhibitors the development of cardiovascular complications in patients with T2DM is a decrease, as well the arterial stiffness, endothelial dysfunction and increasing on the shear stress and blood viscosity; and experimentally.

Key Dates

Start date
Dec 2, 2019
Status verified
Dec 2019
Primary completion
Jun 29, 2020
Completion
Dec 30, 2020

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Dapagliflozin
    Individuals with T2DM controlled with metformin; with no hypertension neither treated with insulin. Dapagliflozin capsules, 10 mg 1 time daily 5 minutes before the first meal
  • Experimental: Empagliflozin
    Individuals with T2DM controlled with metformin; with no hypertension neither treated with insulin. Empagliflozin capsules, 25 mg 1 time daily 5 minutes before the first meal
  • Placebo Comparator: Placebo
    Individuals with T2DM controlled with metformin; with no hypertension neither treated with insulin. Dapagliflozin capsules, 400 mg 1 time daily 5 minutes before the first meal

Primary Outcome Measure

Flow Mediated Dilation [ Time Frame: 7 days ]

Central Contacts

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