Diabetes Mellitus Type 2 Without ComplicationPhase 3NCT05109949
Acute Effect of Empagliflozin vs Dapagliflozin Over Pulse Wave Velocity in Type Two Diabetes
A Phase 3 study testing Dapagliflozin 10Mg Tab and Empagliflozin 25 MG in people with Diabetes Mellitus Type 2 Without Complication, run by Centro Universitario de Ciencias de la Salud, Mexico at 1 site in Mexico.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Diabetes Mellitus Type 2 Without Complication
- What is being tested?
- Dapagliflozin 10Mg Tab and Empagliflozin 25 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteMexico
- Study dates
- 30 Mar 2020to 1 Aug 2022
- 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
- Any autoimmune disease
- Liver disease
Show all 12Show fewer
- 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)
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
About this study
Official title: Acute Effect of Empagliflozin vs Dapagliflozin vs Placebo Administration Over Pulse Wave Velocity in Patients With Type Two Diabetes
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.
Read the 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.
- Being tested
- Dapagliflozin 10Mg Tab, Empagliflozin 25 MG, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10Mg TabDrug
Also called Farxiga, Forxiga
Daily morning dose per oral of Dapagliflozin 10 mg for 7 days
Empagliflozin 25 MGDrug
Also called Jardiance
Daily morning dose per oral of Empagliflozine 25 mg for 7 days
PlaceboOther
Daily morning dose per oral of Calcined magnesite 500 mg for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin 10 mg | Experimental | Dapagliflozin is an oral medication used to treat Type 2 diabetes. It belongs to a sodium-glucose cotransporter 2 (SGLT2) inhibitors. Receives: Drug: Dapagliflozin 10Mg Tab |
| Empagliflozin 25 mg | Experimental | Empagliflozin is an oral medication used to treat Type 2 diabetes. It belongs to sodium-glucose cotransporter 2 (SGLT2) inhibitors. Receives: Drug: Empagliflozin 25 MG |
| Placebo | Placebo comparator | Calcinated magnesium is a white powdery compound, MgO, used in pharmaceuticals as binder. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse wave velocity
Change from baseline carotid-femoral pulse wave velocity at 7 days. Using a PulsePen tonometer by DiaTechne.
Measured: 7 days
Secondary outcomes (7)
Fasting plasma glucose
Change from baseline, using the BioSystems® Glucose Oxidase / Peroxidase kit; in an automated clinical chemistry analysis equipment brand XL-100Erba
Measured: 7 days
Total cholesterol
Change from baseline, using the BioSystems® Glucose Oxidase / Peroxidase kit.
Measured: 7 days
Triglycerides
Change from baseline, using the BioSystems® Glycerol phosphate Oxidase / Peroxidase kit.
Measured: 7 days
High-density lipoprotein cholesterol
Change from baseline, using the BioSystems® Direct / Detergent HDL kit
Measured: 7 days
Low-density lipoprotein cholesterol
Change from baseline, using the BioSystems® Cholesterol Oxidase / Peroxidase kit
Measured: 7 days
Creatinine
Change from baseline, using the BioSystems® kit Modified Jaffe's no deproteinization
Measured: 7 days
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
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 posted5 Nov 2021
- Study start30 Mar 2020
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2 Without ComplicationStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 72 participants (actual)
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-Páez, PhD, Study director, Institute of Experimental and Clinical Therapeutics (INTEC), CUCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05109949
- Sponsor's protocol ID
- CUCS-INTEC-XOLOTL
- Status last verified
- Nov 2021
- First submitted
- 26 Oct 2021
- Last updated
- 19 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effect of Empagliflozin vs Dapagliflozin vs Placebo Administration Over Pulse Wave Velocity in Patients With Type Two Diabetes
- ClinicalTrials.gov ID
- NCT05109949
- Acronym / sponsor ID
- CUCS-INTEC-XOLOTL
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Centro Universitario de Ciencias de la Salud, MexicoUniversity, hospital or other
- Study start
- 30 Mar 2020 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 5 Nov 2021 (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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin 10 mg | Experimental | Drug: Dapagliflozin 10Mg TabDapagliflozin is an oral medication used to treat Type 2 diabetes. It belongs to a sodium-glucose cotransporter 2 (SGLT2) inhibitors. |
| Empagliflozin 25 mg | Experimental | Drug: Empagliflozin 25 MGEmpagliflozin is an oral medication used to treat Type 2 diabetes. It belongs to sodium-glucose cotransporter 2 (SGLT2) inhibitors. |
| Placebo | Placebo comparator | Other: PlaceboCalcinated magnesium is a white powdery compound, MgO, used in pharmaceuticals as binder. |
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
- 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 10Mg TabAlso: Farxiga, ForxigaDaily morning dose per oral of Dapagliflozin 10 mg for 7 days | Drug | Dapagliflozin 10 mg |
| Empagliflozin 25 MGAlso: JardianceDaily morning dose per oral of Empagliflozine 25 mg for 7 days | Drug | Empagliflozin 25 mg |
| PlaceboDaily morning dose per oral of Calcined magnesite 500 mg for 7 days | Other | Placebo |
Primary outcome
Pulse wave velocity
Time frame: 7 days
Change from baseline carotid-femoral pulse wave velocity at 7 days. Using a PulsePen tonometer by DiaTechne.
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 19 Nov 2021.
- 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-Páez, 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 10Mg Tab and Empagliflozin 25 MG in people with Diabetes Mellitus Type 2 Without Complication, 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 19 Nov 2021. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulse wave velocity (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 19 Nov 2021.