Type 2 Diabetes MellitusPhase 3NCT04195243
Dapagliflozin vs Empagliflozin on Flow Mediated Dilation in Type 2 Diabetes Mellitus
A Phase 3 study testing Dapagliflozin Pill and Empagliflozin Pill in people with Type 2 Diabetes Mellitus, run by Centro Universitario de Ciencias de la Salud, Mexico at 1 site in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Dapagliflozin Pill and Empagliflozin Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteMexico
- Study dates
- 2 Dec 2019to 30 Dec 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of T2DM
- HbA1c > 7 y < 10
- BMI 25 - 34.9 kg/m2
- Signature of consent under information
Who cannot join
- Hypertension
- Treated with insulin and / or loop diuretics and thiazides
- T1DM
- Hypotension
- With any autoimmune disease
- Liver disease
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- 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)
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
Guadalajara, Jalisco, 44340
Fernando Grover Paez, PhD, (33) 10585200 ext. 34215, fgroverp@hotmail.com
Fernando Grover Paez, PhD, (33) 10585200 ext. 34215, rballezaa@gmail.com
About this study
Official title: Acute Effect of Dapagliflozin vs Empagliflozin Administration on Flow Mediated Dilation in Patients With Type 2 Diabetes Mellitus
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.
Read the detailed description
The objective of this study, is to evaluate the acute effect of the administration of dapagliflozin in comparison with the administration of empagliflozin on endothelial disfunction in individuals with T2DM; we will conduct a double-blind, randomized, placebo-controlled, trial with 3 groups, each group of 24 male and female patients, between 40-65 years of age with T2DM, without hypertension, treated with insulins or thiazide diuretics. Randomization will determine who will receive the intervention during 7-days trial (Empagliflozin 25 mg 1 time daily 5 minutes or Dapagliflozin 10 mg before the first bite of each meal or approved placebo capsules), the patients will also continue with their usual treatment. The clinical findings and laboratory test and laboratory test include a metabolic profile and biosafety, baseline and at 7 days. Body weight, body fat, body mass index (BMI) and blood pressure will be determined during the initial and final visit, likewise, hemodynamics parameters of endothelial disfunction by flow mediate dilation with a high-resolution UNEX EF38G® ultrasound. Adverse events to treatment will be documented. Statistical analysis: Mann-Whitney U Test and Wilcoxon exact test. A p <0.05 will be considered statistically significant.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Dapagliflozin Pill, Empagliflozin Pill, Placebo pill
- Keywords
- Dapagliflozin, Empagliflozin, FMD, T2DM, Endothelial disfunction
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin PillDrug
Also called Forxiga, Dapagliflozin
The patient will take one pill, every 24 hr, during 7 days
Empagliflozin PillDrug
Also called Jardiance, Empagliflozin
The patient will take one pill, every 24 hr, during 7 days
Placebo pillDrug
Also called Calcined magnesia
The patient will take one pill, every 24 hr, during 7 days
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin | Experimental | Individuals 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 Receives: Drug: Dapagliflozin Pill |
| Empagliflozin | Experimental | Individuals 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 Receives: Drug: Empagliflozin Pill |
| Placebo | Placebo comparator | Individuals 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 Receives: Drug: Placebo pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 days
Secondary outcomes (7)
Fasting plasma glucose
Before and after intervention, using the BioSystems® Glucose Oxidase / Peroxidase kit; in an automated clinical chemistry analysis equipment brand XL-100Erba
Measured: 7 days
Total cholesterol
Before and after intervention, using the BioSystems® Glucose Oxidase / Peroxidase kit.
Measured: 7 days
Triglycerides
Before and after intervention, using the BioSystems® Glycerol phosphate Oxidase / Peroxidase kit.
Measured: 7 days
High-density lipoprotein cholesterol
Before and after intervention, using the BioSystems® Direct / Detergent HDL kit
Measured: 7 days
Low-density lipoprotein cholesterol
Before and after intervention using the BioSystems® Cholesterol Oxidase / Peroxidase kit
Measured: 7 days
Creatinine
Before and after intervention the BioSystems® kit Modified Jaffe's no deproteinization
Measured: 7 days
Blood pressure
Before and after intervention using an OMRON calibrated electronic digital sphygmomanometer model HEM 907 XL will be used. 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
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start2 Dec 2019 (estimated)
- Primary completion29 Jun 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Universitario de Ciencias de la Salud, Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernando Grover Paez, Centro Universitario de Ciencias de la Salud, Mexico
- Investigators
- Fernando Grover Paez, PhD, Study director, Institute of Experimental and Clinical Therapeutics (INTEC), CUCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04195243
- Sponsor's protocol ID
- CUCS-INTEC-MV-HADES-001
- Status last verified
- Dec 2019
- First submitted
- 4 Dec 2019
- Last updated
- 11 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of Dapagliflozin vs Empagliflozin Administration on Flow Mediated Dilation in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04195243
- Acronym / sponsor ID
- CUCS-INTEC-MV-HADES-001
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Dapagliflozin, Empagliflozin, FMD, T2DM, Endothelial disfunction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Centro Universitario de Ciencias de la Salud, MexicoUniversity, hospital or other
- Study start
- 2 Dec 2019 (estimated)
- Primary completion
- 29 Jun 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 11 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The objective of this study, is to evaluate the acute effect of the administration of dapagliflozin in comparison with the administration of empagliflozin on endothelial disfunction in individuals with T2DM; we will conduct a double-blind, randomized, placebo-controlled, trial with 3 groups, each group of 24 male and female patients, between 40-65 years of age with T2DM, without hypertension, treated with insulins or thiazide diuretics. Randomization will determine who will receive the intervention during 7-days trial (Empagliflozin 25 mg 1 time daily 5 minutes or Dapagliflozin 10 mg before the first bite of each meal or approved placebo capsules), the patients will also continue with their usual treatment. The clinical findings and laboratory test and laboratory test include a metabolic profile and biosafety, baseline and at 7 days. Body weight, body fat, body mass index (BMI) and blood pressure will be determined during the initial and final visit, likewise, hemodynamics parameters of endothelial disfunction by flow mediate dilation with a high-resolution UNEX EF38G® ultrasound. Adverse events to treatment will be documented. Statistical analysis: Mann-Whitney U Test and Wilcoxon exact test. A p <0.05 will be considered statistically significant.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin | Experimental | Drug: Dapagliflozin PillIndividuals 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 | Experimental | Drug: Empagliflozin PillIndividuals 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 comparator | Drug: Placebo pillIndividuals 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 |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of T2DM
- HbA1c > 7 y < 10
- BMI 25 - 34.9 kg/m2
- Signature of consent under information
Key exclusion criteria (12 listed)
- Hypertension
- Treated with insulin and / or loop diuretics and thiazides
- T1DM
- Hypotension
- With any autoimmune disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dapagliflozin PillAlso: Forxiga, DapagliflozinThe patient will take one pill, every 24 hr, during 7 days | Drug | Dapagliflozin |
| Empagliflozin PillAlso: Jardiance, EmpagliflozinThe patient will take one pill, every 24 hr, during 7 days | Drug | Empagliflozin |
| Placebo pillAlso: Calcined magnesiaThe patient will take one pill, every 24 hr, during 7 days | Drug | Placebo |
Primary outcome
Flow Mediated Dilation
Time frame: 7 days
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 secondary outcomes
Fasting plasma glucose
Time frame: 7 days
Total cholesterol
Time frame: 7 days
Triglycerides
Time frame: 7 days
High-density lipoprotein cholesterol
Time frame: 7 days
Low-density lipoprotein cholesterol
Time frame: 7 days
Creatinine
Time frame: 7 days
Blood pressure
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernando Grover Paez, PhD study director
Institute of Experimental and Clinical Therapeutics (INTEC), CUCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dapagliflozin Pill and Empagliflozin Pill in people with Type 2 Diabetes Mellitus, run by Centro Universitario de Ciencias de la Salud, Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fernando Grover Paez, PhD ((33) 10585200 ext. 34215, fgroverp@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flow Mediated Dilation (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2019.