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

Acute Effect of Empagliflozin vs Dapagliflozin vs Placebo Administration Over Pulse Wave Velocity in Patients With Type Two Diabetes

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetes Mellitus Type 2 Without Complication
• Intervention / Treatment: Drug: Dapagliflozin 10Mg Tab; Drug: Empagliflozin 25 MG; Other: Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 3

Contacts and Locations

Study Locations

• Mexico
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44340
      • Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Dapagliflozin 10Mg Tab; Daily morning dose per oral of Dapagliflozin 10 mg for 7 days; Other Names: Farxiga, Forxiga
Experimental: Empagliflozin 25 mg; Empagliflozin is an oral medication used to treat Type 2 diabetes. It belongs to sodium-glucose cotransporter 2 (SGLT2) inhibitors.	Drug: Empagliflozin 25 MG; Daily morning dose per oral of Empagliflozine 25 mg for 7 days; Other Names: Jardiance
Placebo Comparator: Placebo; Calcinated magnesium is a white powdery compound, MgO, used in pharmaceuticals as binder.	Other: Placebo; Daily morning dose per oral of Calcined magnesite 500 mg for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulse wave velocity	Change from baseline carotid-femoral pulse wave velocity at 7 days. Using a PulsePen tonometer by DiaTechne.	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting plasma glucose	Change from baseline, using the BioSystems® Glucose Oxidase / Peroxidase kit; in an automated clinical chemistry analysis equipment brand XL-100Erba	7 days
Total cholesterol	Change from baseline, using the BioSystems® Glucose Oxidase / Peroxidase kit.	7 days
Triglycerides	Change from baseline, using the BioSystems® Glycerol phosphate Oxidase / Peroxidase kit.	7 days
High-density lipoprotein cholesterol	Change from baseline, using the BioSystems® Direct / Detergent HDL kit	7 days
Low-density lipoprotein cholesterol	Change from baseline, using the BioSystems® Cholesterol Oxidase / Peroxidase kit	7 days
Creatinine	Change from baseline, using the BioSystems® kit Modified Jaffe's no deproteinization	7 days
Blood pressure	Change from baseline, using an OMRON calibrated electronic digital sphygmomanometer model HEM 907 XL. The patient will remain seated in a chair resting his back on the backrest, with a minimum rest of 5 minutes, The average of 3 measurements such as BP will be taken	7 days

Collaborators and Investigators

• Sponsor: Centro Universitario de Ciencias de la Salud, Mexico
• Investigators: Study Director: Fernando Grover-Páez, PhD, Institute of Experimental and Clinical Therapeutics (INTEC), CUCS

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2020
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): August 1, 2022

Study Registration Dates

• First Submitted: October 26, 2021
• First Submitted That Met QC Criteria: October 26, 2021
• First Posted (Actual): November 5, 2021

Study Record Updates

• Last Update Posted (Actual): November 19, 2021
• Last Update Submitted That Met QC Criteria: November 11, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors; Dapagliflozin; Empagliflozin
• Other Study ID Numbers: CUCS-INTEC-XOLOTL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No