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

Centro Universitario de Ciencias de la Salud, Mexico

Status and phase: Unknown; Phase 3

Conditions: Diabetes Mellitus Type 2 Without Complication

Treatments: Drug: Dapagliflozin 10Mg Tab; Drug: Empagliflozin 25 MG; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05109949

CUCS-INTEC-XOLOTL

Details and patient eligibility

About

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.

Full description

Measure basal carotid-femoral Pulse Wave Velocity through a Pulse Pen tonometer by DiaTecne among basic physical examination, blood test, anthropometric and hemodynamic measurements; then administrate randomly dapagliflozin 10 mg, empagliflozin 25 mg or placebo for 7 days and then perform all of the measurements and blood test again.

Enrollment: 72 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of T2DM
• HbA1c > 7 y < 10
• BMI 25 - 34.9 kg/m2
• Signature of consent under information

Exclusion criteria

• Hypertension
• Treated with insulin and / or loop diuretics and thiazides
• T1DM
• Hypotension
• Any autoimmune disease
• Liver disease
• Women whitout birth control method
• Women taking oral birth control or under hormone replacement therapy
• Woman pregnant or breastfeeding
• Untreated thyroid disease
• Patients with a cardiovascular disease that contraindicates the use of this pharmacological class
• Glomerular filtration rate <60ml/min (Cockcroft-Gault)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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72 participants in 3 patient groups, including a placebo group

Dapagliflozin 10 mg

Experimental group

Description:

Dapagliflozin is an oral medication used to treat Type 2 diabetes. It belongs to a sodium-glucose cotransporter 2 (SGLT2) inhibitors.

Treatment:

Drug: Dapagliflozin 10Mg Tab

Empagliflozin 25 mg

Experimental group

Description:

Empagliflozin is an oral medication used to treat Type 2 diabetes. It belongs to sodium-glucose cotransporter 2 (SGLT2) inhibitors.

Treatment:

Drug: Empagliflozin 25 MG

Placebo

Placebo Comparator group

Description:

Calcinated magnesium is a white powdery compound, MgO, used in pharmaceuticals as binder.

Treatment:

Other: Placebo