Acute Effect of Empagliflozin vs Dapagliflozin Over Pulse Wave Velocity in Type Two Diabetes
1 other identifier
interventional
72
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Mar 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 30, 2020
CompletedFirst Submitted
Initial submission to the registry
October 26, 2021
CompletedFirst Posted
Study publicly available on registry
November 5, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2022
CompletedNovember 19, 2021
November 1, 2021
2.2 years
October 26, 2021
November 11, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Pulse wave velocity
Change from baseline carotid-femoral pulse wave velocity at 7 days. Using a PulsePen tonometer by DiaTechne.
7 days
Secondary Outcomes (7)
Fasting plasma glucose
7 days
Total cholesterol
7 days
Triglycerides
7 days
High-density lipoprotein cholesterol
7 days
Low-density lipoprotein cholesterol
7 days
- +2 more secondary outcomes
Study Arms (3)
Dapagliflozin 10 mg
EXPERIMENTALDapagliflozin is an oral medication used to treat Type 2 diabetes. It belongs to a sodium-glucose cotransporter 2 (SGLT2) inhibitors.
Empagliflozin 25 mg
EXPERIMENTALEmpagliflozin is an oral medication used to treat Type 2 diabetes. It belongs to sodium-glucose cotransporter 2 (SGLT2) inhibitors.
Placebo
PLACEBO COMPARATORCalcinated magnesium is a white powdery compound, MgO, used in pharmaceuticals as binder.
Interventions
Daily morning dose per oral of Dapagliflozin 10 mg for 7 days
Daily morning dose per oral of Empagliflozine 25 mg for 7 days
Eligibility Criteria
You may qualify if:
- Diagnosis of T2DM
- HbA1c \> 7 y \< 10
- BMI 25 - 34.9 kg/m2
- Signature of consent under information
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
Guadalajara, Jalisco, 44340, Mexico
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Fernando Grover-Páez, PhD
Institute of Experimental and Clinical Therapeutics (INTEC), CUCS
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 26, 2021
First Posted
November 5, 2021
Study Start
March 30, 2020
Primary Completion
June 1, 2022
Study Completion
August 1, 2022
Last Updated
November 19, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share