Dapagliflozin vs Empagliflozin on Flow Mediated Dilation in Type 2 Diabetes Mellitus
Acute Effect of Dapagliflozin vs Empagliflozin Administration on Flow Mediated Dilation in Patients With Type 2 Diabetes Mellitus
1 other identifier
interventional
24
1 country
1
Brief Summary
Type 2 diabetes mellitus (T2DM) is a considered one of the main global health challenges; the vascular endothelium plays an important role in vascular dysfunction in DM; Hyperglycemia induced by it is recognized as the main factor for the development of vascular complications of the disease, secondary to a reduction in nitric oxide production; "flow-mediated dilation" is the most commonly used technique for the evaluation of endothelial function, being the non-invasive method most widely used. It has been reported that with the use of SGLT2 inhibitors the development of cardiovascular complications in patients with T2DM is a decrease, as well the arterial stiffness, endothelial dysfunction and increasing on the shear stress and blood viscosity; and experimentally.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 type-2-diabetes-mellitus
Started Dec 2019
Shorter than P25 for phase_3 type-2-diabetes-mellitus
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
December 2, 2019
CompletedFirst Submitted
Initial submission to the registry
December 4, 2019
CompletedFirst Posted
Study publicly available on registry
December 11, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 29, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2020
CompletedDecember 11, 2019
December 1, 2019
7 months
December 4, 2019
December 10, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Flow Mediated Dilation
Change from baseline Flow mediated dilation at 7 days. Using a high-resolution UNEX EF38G ultrasound®, in a room at 22°C, with the patient lying supine, and the right arm extended
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
EXPERIMENTALIndividuals with T2DM controlled with metformin; with no hypertension neither treated with insulin. Dapagliflozin capsules, 10 mg 1 time daily 5 minutes before the first meal
Empagliflozin
EXPERIMENTALIndividuals with T2DM controlled with metformin; with no hypertension neither treated with insulin. Empagliflozin capsules, 25 mg 1 time daily 5 minutes before the first meal
Placebo
PLACEBO COMPARATORIndividuals with T2DM controlled with metformin; with no hypertension neither treated with insulin. Dapagliflozin capsules, 400 mg 1 time daily 5 minutes before the first meal
Interventions
The patient will take one pill, every 24 hr, during 7 days
The patient will take one pill, every 24 hr, during 7 days
The patient will take one pill, every 24 hr, during 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
- With any autoimmune disease
- Liver disease
- Women who do not have a safe method of contraception
- Women who are taking oral contraceptives or under treatment with 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
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Fernando Grover Paez, PhD
Institute of Experimental and Clinical Therapeutics (INTEC), CUCS
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Investigador Principal
Study Record Dates
First Submitted
December 4, 2019
First Posted
December 11, 2019
Study Start
December 2, 2019
Primary Completion
June 29, 2020
Study Completion
December 30, 2020
Last Updated
December 11, 2019
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share