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

Phase 3

• Conditions: Diabetes Mellitus Type 2 Without Complication
• Interventions: Drug: Dapagliflozin 10Mg Tab; Other: Placebo; Drug: Empagliflozin 25 MG

• Registration Number: NCT05109949
• Lead Sponsor: Centro Universitario de Ciencias de la Salud, Mexico

Brief 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.

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 Timeline

• Study Start: 2020-03-30
• Study First Submitted: 2021-10-26
• Study First Submitted QC: 2021-10-26
• Status Verified: 2021-11
• Study First Posted: 2021-11-05
• Last Update Submitted: 2021-11-11
• Last Update Posted: 2021-11-19
• Primary Completion: 2022-06-01
• Study Completion: 2022-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dapagliflozin 10 mg	Dapagliflozin 10Mg Tab	Dapagliflozin is an oral medication used to treat Type 2 diabetes. It belongs to a sodium-glucose cotransporter 2 (SGLT2) inhibitors.
Placebo	Placebo	Calcinated magnesium is a white powdery compound, MgO, used in pharmaceuticals as binder.
Empagliflozin 25 mg	Empagliflozin 25 MG	Empagliflozin is an oral medication used to treat Type 2 diabetes. It belongs to sodium-glucose cotransporter 2 (SGLT2) inhibitors.

Primary Outcome Measures

Name	Time	Method
Pulse wave velocity	7 days	Change from baseline carotid-femoral pulse wave velocity at 7 days. Using a PulsePen tonometer by DiaTechne.

Secondary Outcome Measures

Name	Time	Method
Total cholesterol	7 days	Change from baseline, using the BioSystems® Glucose Oxidase / Peroxidase kit.
Low-density lipoprotein cholesterol	7 days	Change from baseline, using the BioSystems® Cholesterol Oxidase / Peroxidase kit
Creatinine	7 days	Change from baseline, using the BioSystems® kit Modified Jaffe's no deproteinization
Fasting plasma glucose	7 days	Change from baseline, using the BioSystems® Glucose Oxidase / Peroxidase kit; in an automated clinical chemistry analysis equipment brand XL-100Erba
Triglycerides	7 days	Change from baseline, using the BioSystems® Glycerol phosphate Oxidase / Peroxidase kit.
High-density lipoprotein cholesterol	7 days	Change from baseline, using the BioSystems® Direct / Detergent HDL kit
Blood pressure	7 days	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

Trial Locations

Locations (1)

Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara; 🇲🇽 Guadalajara, Jalisco, Mexico