search
Back to results

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

Primary Purpose

Diabetes Mellitus Type 2 Without Complication

Status
Active
Phase
Phase 3
Locations
Mexico
Study Type
Interventional
Intervention
Dapagliflozin 10Mg Tab
Empagliflozin 25 MG
Placebo
Sponsored by
Centro Universitario de Ciencias de la Salud, Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetes Mellitus Type 2 Without Complication

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Dapagliflozin 10 mg

Empagliflozin 25 mg

Placebo

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 26, 2021
Last Updated
November 11, 2021
Sponsor
Centro Universitario de Ciencias de la Salud, Mexico
search

1. Study Identification

Unique Protocol Identification Number
NCT05109949
Brief Title
Acute Effect of Empagliflozin vs Dapagliflozin Over Pulse Wave Velocity in Type Two Diabetes
Official Title
Acute Effect of Empagliflozin vs Dapagliflozin vs Placebo Administration Over Pulse Wave Velocity in Patients With Type Two Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 30, 2020 (Actual)
Primary Completion Date
June 1, 2022 (Anticipated)
Study Completion Date
August 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro Universitario de Ciencias de la Salud, Mexico

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 2 Without Complication

7. Study Design

Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dapagliflozin 10 mg
Arm Type
Experimental
Arm Description
Dapagliflozin is an oral medication used to treat Type 2 diabetes. It belongs to a sodium-glucose cotransporter 2 (SGLT2) inhibitors.
Arm Title
Empagliflozin 25 mg
Arm Type
Experimental
Arm Description
Empagliflozin is an oral medication used to treat Type 2 diabetes. It belongs to sodium-glucose cotransporter 2 (SGLT2) inhibitors.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Calcinated magnesium is a white powdery compound, MgO, used in pharmaceuticals as binder.
Intervention Type
Drug
Intervention Name(s)
Dapagliflozin 10Mg Tab
Other Intervention Name(s)
Farxiga, Forxiga
Intervention Description
Daily morning dose per oral of Dapagliflozin 10 mg for 7 days
Intervention Type
Drug
Intervention Name(s)
Empagliflozin 25 MG
Other Intervention Name(s)
Jardiance
Intervention Description
Daily morning dose per oral of Empagliflozine 25 mg for 7 days
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Daily morning dose per oral of Calcined magnesite 500 mg for 7 days
Primary Outcome Measure Information:
Title
Pulse wave velocity
Description
Change from baseline carotid-femoral pulse wave velocity at 7 days. Using a PulsePen tonometer by DiaTechne.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Fasting plasma glucose
Description
Change from baseline, using the BioSystems® Glucose Oxidase / Peroxidase kit; in an automated clinical chemistry analysis equipment brand XL-100Erba
Time Frame
7 days
Title
Total cholesterol
Description
Change from baseline, using the BioSystems® Glucose Oxidase / Peroxidase kit.
Time Frame
7 days
Title
Triglycerides
Description
Change from baseline, using the BioSystems® Glycerol phosphate Oxidase / Peroxidase kit.
Time Frame
7 days
Title
High-density lipoprotein cholesterol
Description
Change from baseline, using the BioSystems® Direct / Detergent HDL kit
Time Frame
7 days
Title
Low-density lipoprotein cholesterol
Description
Change from baseline, using the BioSystems® Cholesterol Oxidase / Peroxidase kit
Time Frame
7 days
Title
Creatinine
Description
Change from baseline, using the BioSystems® kit Modified Jaffe's no deproteinization
Time Frame
7 days
Title
Blood pressure
Description
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
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernando Grover-Páez, PhD
Organizational Affiliation
Institute of Experimental and Clinical Therapeutics (INTEC), CUCS
Official's Role
Study Director
Facility Information:
Facility Name
Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44340
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs