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

Centro Universitario de Ciencias de la Salud, Mexico

Status and phase: Unknown; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Empagliflozin Pill; Drug: Dapagliflozin Pill; Drug: Placebo pill

Study type: Interventional

Funder types: Other

Identifiers

NCT04195243

CUCS-INTEC-MV-HADES-001

Details and patient eligibility

About

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.

Full description

The objective of this study, is to evaluate the acute effect of the administration of dapagliflozin in comparison with the administration of empagliflozin on endothelial disfunction in individuals with T2DM; we will conduct a double-blind, randomized, placebo-controlled, trial with 3 groups, each group of 24 male and female patients, between 40-65 years of age with T2DM, without hypertension, treated with insulins or thiazide diuretics. Randomization will determine who will receive the intervention during 7-days trial (Empagliflozin 25 mg 1 time daily 5 minutes or Dapagliflozin 10 mg before the first bite of each meal or approved placebo capsules), the patients will also continue with their usual treatment. The clinical findings and laboratory test and laboratory test include a metabolic profile and biosafety, baseline and at 7 days. Body weight, body fat, body mass index (BMI) and blood pressure will be determined during the initial and final visit, likewise, hemodynamics parameters of endothelial disfunction by flow mediate dilation with a high-resolution UNEX EF38G® ultrasound. Adverse events to treatment will be documented. Statistical analysis: Mann-Whitney U Test and Wilcoxon exact test. A p <0.05 will be considered statistically significant.

Enrollment: 24 estimated 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
• With any autoimmune disease
• Liver disease
• Women who do not have a safe method of contraception
• Women who are taking oral contraceptives or under treatment with 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: Single Blind

---

24 participants in 3 patient groups, including a placebo group

Dapagliflozin

Experimental group

Description:

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

Treatment:

Drug: Dapagliflozin Pill

Empagliflozin

Experimental group

Description:

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

Treatment:

Drug: Empagliflozin Pill

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo pill