Diabetes Mellitus, Type 2Phase 4NCT02919059
Study to Asses the Effect of Dapagliflozin on Central Blood Pressure Reduction.
A Phase 4 study testing Dapagliflozin 10 mg and Glimepiride 4 mg in people with Diabetes Mellitus, Type 2, run by IInstituto Gallego de Medicina Vascular at 1 site in Spain.
Trial summary
This superiority of central pressure versus peripheral measures to predict cardiovascular events has also been reported in general population or in elder people Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Dapagliflozin 10 mg and Glimepiride 4 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteSpain
- Study dates
- 13 Dec 2016to Aug 2019
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- T2DM subjects with uncontrolled glycaemia, based on HbA1c levels (10% ≥ HbA1c ≥ 7%) at Visit 1.
- Patients may be treated for >3 months with a stable doses of metformin at optimal doses tolerated.
- Participants will be able to give and sign informed consent form.
- Age > 18 years of either gender.
Who cannot join
- Patients with two or more different oral antihyperglycemic agents.
- HbA 1c levels > 10%.
- Systolic BP >160 mm Hg and/or diastolic BP > 100 mm Hg before randomization.
- History of diabetic ketoacidosis, T1DM, pancreas or beta-cell transplantation or diabetes secondary to any condition.
- History of one or more severe hypoglycaemic episode within 6 months before screening.
- Myocardial infarction, unstable angina pectoris, congestive heart failure, life threatening arrhythmia, history of cerebrovascular accident within 3 months.
Show all 20Show fewer
- Clinically relevant renal disease; defines if serum creatinine equal or lager than 1.5 mg/dl or eGFR < 60 ml/min/1.73m2, at screening.
- Liver function abnormal: glutamic-oxalacetic transaminase lager than 2 times of upper limit normal or glutamic-pyruvic transaminase lager than 2 times of upper limit normal
- Existence of any serious systemic disease
- Allergic history to the compounds of study medication
- Can not comply the study protocol or misunderstand the informed consent form
- Women of childbearing potential will be required to use a double-barrier method of birth control throughout study participation. Women who are surgically sterile or documented post-menopausal for at least 2 years are not considered to be of childbearing potential.
- Pregnant or breast-feeding or planning to become pregnant during the study.
- History of alcohol abuse (>350 g/week) within 3 years before screening.
- Concurrent therapy with medications that could be affect glycaemia (e.g. corticosteroids) or disallowed therapy (e.g. digoxin).
- Investigational drug treatment within the past 4 months
- Concomitant psychiatric diseases and/or habit/abuse of psychoactive substances
- Predictable lack of co-operation
- Shifts workers
- Employees of the investigator or study centre.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Nuestra Señora de la Esperanza
Santiago de Compostela, Galicia, 15705
Álvaro Hermida, MD, PhD, 0034 981 552 200, alvaro.hermida.ameijeiras@sergas.es
About this study
Official title: A Randomized, Unicenter, Parallel Study of the Effect of Dapagliflozin on Central Blood Pressure Reduction Compared to Glimepiride in Adult Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control.
This superiority of central pressure versus peripheral measures to predict cardiovascular events has also been reported in general population or in elder people
Read the detailed description
The prognostic value of central systolic/diastolic pressure, central pulse pressure and AI has been well demonstrated, firstly after CAFÉ study, with 2073 hypertensive subjects followed up 3.4 years. It also evidenced higher prognostic value of central blood pressure compared to peripheral blood pressure. One year later, the STRONG study, showed central pulse pressure to be an independent cardiovascular risk factor as well as higher prognostic value compared to peripheral pulse pressure (Hazard ratio; 1,1510 mmHg Vs 1,10mmHg; X2: 13,4; p < 0,001). Those subjects with higher central blood pressure and central pulse pressure showed higher incidence of cardiovascular events. This superiority of central pressure versus peripheral measures to predict cardiovascular events has also been reported in general population or in elder people.
Finally, it has been also reported that dapagliflozin modestly reduces systolic blood pressure in patients with T2DM who were mostly receiving treatment for hypertension. Despite office blood pressure remains the gold standard method for screening, diagnostic and treatment of hypertension, it has been also well demonstrated that ambulatory blood pressure monitoring (ABPM) better estimates cardiovascular risk and target organ damage than office blood pressure. It still remains unclear the effects on 24 hours blood pressure reduction with SGLT-2 inhibitors.
The effects of SGLT2 inhibitors on central blood pressure reduction have not been documented.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Dapagliflozin 10 mg, Glimepiride 4 mg
- Keywords
- Diabetes Mellitus, Type 2, DM
- 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 10 mgDrug
Also called Dapagliflozin
Dagliflozin will be administred once daily before the first meal of the day for the duration of the study or until early discontinuation. Subjects will take the first dose of study drug at the study centre on Day 1.
On the day of study visits when fasting blood samples are collected, subjects will be instructed to refrain from taking the study drug before the clinic visit. The subject will be instructed to take the dose of study drug before the subject´s next meal.
The study drug must be swallowed whole with liquid and not chewed, divided, dissolved or crushed. If the subject doesn´t take the study drug within 12 hours after the first meal of the day, the dose of the study drug should be skipped for that day and keep on taking the study drug on the following day before the first meal.
Glimepiride 4 mgDrug
Also called Glimepiride
Glimepiride will be administred once daily before the first meal of the day for the duration of the study or until early discontinuation. Subjects will take the first dose of study drug at the study centre on Day 1.
On the day of study visits when fasting blood samples are collected, subjects will be instructed to refrain from taking the study drug before the clinic visit. The subject will be instructed to take the dose of study drug before the subject´s next meal.
The study drug must be swallowed whole with liquid and not chewed, divided, dissolved or crushed. If the subject doesn´t take the study drug within 12 hours after the first meal of the day, the dose of the study drug should be skipped for that day and keep on taking the study drug on the following day before the first meal.
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin 10 mg | Experimental | Dapagliflozin 10 mg once daily during 24 weeks Receives: Drug: Dapagliflozin 10 mg |
| Glimepiride 4 mg | Active comparator | Glimepiride 4 mg once daily during 24 weeks Receives: Drug: Glimepiride 4 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of dapagliflozin relative to glimepiride at 24 weeks of treatment period regarding central systolic blood pressure
To assess the effect of dapagliflozin relative to glimepiride at 24 weeks of treatment period in subjects with T2DM, with inadequate glycemic control regarding central systolic blood pressure estimated by applanation tonometry
Measured: 24 weeks
Secondary outcomes (6)
Effect of dapagliflozin relative to glimepiride at 24 weeks regarding central systolic/diastolic blood pressure
To assess the effect of dapagliflozin relative to glimepiride at 24 weeks of treatment period in subjects with T2DM, with inadequate glycemic control regarding central systolic/diastolic blood pressure estimated by applanation tonometry.
Measured: 24 weeks
Effect of dapagliflozin relative to glimepiride at 24 weeks regarding central pulse pressure
To assess the effect of dapagliflozin relative to glimepiride at 24 weeks of treatment period in subjects with T2DM, with inadequate glycemic control regarding central pulse pressure estimated by applanation tonometry.
Measured: 24 weeks
Effect of dapagliflozin relative to glimepiride at 24 weeks of treatment with inadequate glycemic control regarding 24 hours ambulatory systolic/diastolic blood pressure
To assess the effect of dapagliflozin relative to glimepiride at 24 weeks of treatment period in subjects with T2DM, with inadequate glycemic control regarding 24 hours ambulatory systolic/diastolic blood pressure.
Measured: 24 weeks
Type and number of Adverse events in patienteSafety and tolerability of dapagliflozin relative to glimepiride.
Type and number of Adverse events to assess the safety and tolerability of dapagliflozin relative to glimepiride.
Measured: 28 weeks
Effect of dapagliflozin relative to glimepiride at 24 weeks with inadequate glycemic control regarding augmentation pressure
To assess the effect of dapagliflozin relative to glimepiride at 24 weeks of treatment period in subjects with T2DM, with inadequate glycemic control regarding augmentation pressure estimated by applanation tonometry.
Measured: 24 weeks
Effect of dapagliflozin relative to glimepiride at 24 weeks with inadequate glycemic control regarding augmentation index
- assess the effect of dapagliflozin relative to glimepiride at 24 weeks of treatment period in subjects with T2DM, with inadequate glycemic control regarding augmentation index estimated by applanation tonometry.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2016 (estimated)
- Study start13 Dec 2016
- Primary completionDec 2018 (estimated)
- Study completionAug 2019 (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 2Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 159 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IInstituto Gallego de Medicina Vascular
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alvaro Hermida, MD, PhD, Study director, Hospital Nuestra Señora de la Esperanza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02919059
- Sponsor's protocol ID
- ESR-14-10158
- Status last verified
- Mar 2017
- First submitted
- 23 Sep 2016
- Last updated
- 29 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Unicenter, Parallel Study of the Effect of Dapagliflozin on Central Blood Pressure Reduction Compared to Glimepiride in Adult Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control.
- ClinicalTrials.gov ID
- NCT02919059
- Acronym / sponsor ID
- ESR-14-10158
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes Mellitus, Type 2, DM
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 159 participants (estimated)
- Lead sponsor
- IInstituto Gallego de Medicina VascularUniversity, hospital or other
- Study start
- 13 Dec 2016 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 29 Sep 2016 (estimated)
- 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.
This superiority of central pressure versus peripheral measures to predict cardiovascular events has also been reported in general population or in elder people
Detailed description
The prognostic value of central systolic/diastolic pressure, central pulse pressure and AI has been well demonstrated, firstly after CAFÉ study, with 2073 hypertensive subjects followed up 3.4 years. It also evidenced higher prognostic value of central blood pressure compared to peripheral blood pressure. One year later, the STRONG study, showed central pulse pressure to be an independent cardiovascular risk factor as well as higher prognostic value compared to peripheral pulse pressure (Hazard ratio; 1,1510 mmHg Vs 1,10mmHg; X2: 13,4; p < 0,001). Those subjects with higher central blood pressure and central pulse pressure showed higher incidence of cardiovascular events. This superiority of central pressure versus peripheral measures to predict cardiovascular events has also been reported in general population or in elder people.
Finally, it has been also reported that dapagliflozin modestly reduces systolic blood pressure in patients with T2DM who were mostly receiving treatment for hypertension. Despite office blood pressure remains the gold standard method for screening, diagnostic and treatment of hypertension, it has been also well demonstrated that ambulatory blood pressure monitoring (ABPM) better estimates cardiovascular risk and target organ damage than office blood pressure. It still remains unclear the effects on 24 hours blood pressure reduction with SGLT-2 inhibitors.
The effects of SGLT2 inhibitors on central blood pressure reduction have not been documented.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin 10 mg | Experimental | Drug: Dapagliflozin 10 mgDapagliflozin 10 mg once daily during 24 weeks |
| Glimepiride 4 mg | Active comparator | Drug: Glimepiride 4 mgGlimepiride 4 mg once daily during 24 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- T2DM subjects with uncontrolled glycaemia, based on HbA1c levels (10% ≥ HbA1c ≥ 7%) at Visit 1.
- Patients may be treated for >3 months with a stable doses of metformin at optimal doses tolerated.
- Participants will be able to give and sign informed consent form.
- Age > 18 years of either gender.
Key exclusion criteria (20 listed)
- Patients with two or more different oral antihyperglycemic agents.
- HbA 1c levels > 10%.
- Systolic BP >160 mm Hg and/or diastolic BP > 100 mm Hg before randomization.
- History of diabetic ketoacidosis, T1DM, pancreas or beta-cell transplantation or diabetes secondary to any condition.
- History of one or more severe hypoglycaemic episode within 6 months before screening.
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 10 mgAlso: DapagliflozinDagliflozin will be administred once daily before the first meal of the day for the duration of the study or until early discontinuation. Subjects will take the first dose of study drug at the study centre on Day 1. On the day of study visits when fasting blood samples are collected, subjects will be instructed to refrain from taking the study drug before the clinic visit. The subject will be instructed to take the dose of study drug before the subject´s next meal. The study drug must be swallowed whole with liquid and not chewed, divided, dissolved or crushed. If the subject doesn´t take the study drug within 12 hours after the first meal of the day, the dose of the study drug should be skipped for that day and keep on taking the study drug on the following day before the first meal. | Drug | Dapagliflozin 10 mg |
| Glimepiride 4 mgAlso: GlimepirideGlimepiride will be administred once daily before the first meal of the day for the duration of the study or until early discontinuation. Subjects will take the first dose of study drug at the study centre on Day 1. On the day of study visits when fasting blood samples are collected, subjects will be instructed to refrain from taking the study drug before the clinic visit. The subject will be instructed to take the dose of study drug before the subject´s next meal. The study drug must be swallowed whole with liquid and not chewed, divided, dissolved or crushed. If the subject doesn´t take the study drug within 12 hours after the first meal of the day, the dose of the study drug should be skipped for that day and keep on taking the study drug on the following day before the first meal. | Drug | Glimepiride 4 mg |
Primary outcome
Effect of dapagliflozin relative to glimepiride at 24 weeks of treatment period regarding central systolic blood pressure
Time frame: 24 weeks
To assess the effect of dapagliflozin relative to glimepiride at 24 weeks of treatment period in subjects with T2DM, with inadequate glycemic control regarding central systolic blood pressure estimated by applanation tonometry
6 secondary outcomes
Effect of dapagliflozin relative to glimepiride at 24 weeks regarding central systolic/diastolic blood pressure
Time frame: 24 weeks
Effect of dapagliflozin relative to glimepiride at 24 weeks regarding central pulse pressure
Time frame: 24 weeks
Effect of dapagliflozin relative to glimepiride at 24 weeks of treatment with inadequate glycemic control regarding 24 hours ambulatory systolic/diastolic blood pressure
Time frame: 24 weeks
Type and number of Adverse events in patienteSafety and tolerability of dapagliflozin relative to glimepiride.
Time frame: 28 weeks
Effect of dapagliflozin relative to glimepiride at 24 weeks with inadequate glycemic control regarding augmentation pressure
Time frame: 24 weeks
Effect of dapagliflozin relative to glimepiride at 24 weeks with inadequate glycemic control regarding augmentation index
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
- 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.
Alvaro Hermida, MD, PhD study director
Hospital Nuestra Señora de la Esperanza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dapagliflozin 10 mg and Glimepiride 4 mg in people with Diabetes Mellitus, Type 2, run by IInstituto Gallego de Medicina Vascular at 1 site in Spain.
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 20 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 29 Mar 2017. 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 Spain. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Alvaro Hermida, MD, PhD (0034 981 552 200, alvaro.hermida.ameijeiras@sergas.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of dapagliflozin relative to glimepiride at 24 weeks of treatment period regarding central systolic blood pressure (time frame: 24 weeks). 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 29 Mar 2017.