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

Diabetes Mellitus Type 2 Without Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05109949
• Other study ID #: CUCS-INTEC-XOLOTL
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: March 30, 2020
• Est. completion date: August 1, 2022

Study information

• Verified date: November 2021
• Source: Centro Universitario de Ciencias de la Salud, Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 72
• Est. completion date: August 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2 Without Complication
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Dapagliflozin 10Mg Tab
Daily morning dose per oral of Dapagliflozin 10 mg for 7 days
• Empagliflozin 25 MG
Daily morning dose per oral of Empagliflozine 25 mg for 7 days

Other:
• Placebo
Daily morning dose per oral of Calcined magnesite 500 mg for 7 days

Locations

Country	Name	City	State
Mexico	Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
Centro Universitario de Ciencias de la Salud, Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulse wave velocity	Change from baseline carotid-femoral pulse wave velocity at 7 days. Using a PulsePen tonometer by DiaTechne.	7 days
Secondary	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
Secondary	Total cholesterol	Change from baseline, using the BioSystems® Glucose Oxidase / Peroxidase kit.	7 days
Secondary	Triglycerides	Change from baseline, using the BioSystems® Glycerol phosphate Oxidase / Peroxidase kit.	7 days
Secondary	High-density lipoprotein cholesterol	Change from baseline, using the BioSystems® Direct / Detergent HDL kit	7 days
Secondary	Low-density lipoprotein cholesterol	Change from baseline, using the BioSystems® Cholesterol Oxidase / Peroxidase kit	7 days
Secondary	Creatinine	Change from baseline, using the BioSystems® kit Modified Jaffe's no deproteinization	7 days
Secondary	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