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Study to Asses the Effect of Dapagliflozin on Central Blood Pressure Reduction.

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ClinicalTrials.gov Identifier: NCT02919059
Recruitment Status : Recruiting
First Posted : September 29, 2016
Last Update Posted : March 29, 2017
Sponsor:
Information provided by (Responsible Party):
IInstituto Gallego de Medicina Vascular

Brief Summary:
This superiority of central pressure versus peripheral measures to predict cardiovascular events has also been reported in general population or in elder people

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Dapagliflozin 10 mg Drug: Glimepiride 4 mg Phase 4

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 159 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
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.
Actual Study Start Date : December 13, 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dapagliflozin 10 mg
Dapagliflozin 10 mg once daily during 24 weeks
Drug: Dapagliflozin 10 mg

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.

Other Name: Dapagliflozin

Active Comparator: Glimepiride 4 mg
Glimepiride 4 mg once daily during 24 weeks
Drug: Glimepiride 4 mg

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.

Other Name: Glimepiride




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Effect of dapagliflozin relative to glimepiride at 24 weeks regarding central systolic/diastolic 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/diastolic blood pressure estimated by applanation tonometry.

  2. Effect of dapagliflozin relative to glimepiride at 24 weeks regarding central pulse 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 pulse pressure estimated by applanation tonometry.

  3. 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 ]
    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.

  4. Type and number of Adverse events in patienteSafety and tolerability of dapagliflozin relative to glimepiride. [ Time Frame: 28 weeks ]
    Type and number of Adverse events to assess the safety and tolerability of dapagliflozin relative to glimepiride.

  5. Effect of dapagliflozin relative to glimepiride at 24 weeks with inadequate glycemic control regarding augmentation 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 augmentation pressure estimated by applanation tonometry.

  6. Effect of dapagliflozin relative to glimepiride at 24 weeks with inadequate glycemic control regarding augmentation index [ Time Frame: 24 weeks ]
    o 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02919059


Contacts
Contact: Alvaro Hermida, MD, PhD 0034 981 552 200 alvaro.hermida.ameijeiras@sergas.es

Locations
Spain
Hospital Nuestra Señora de la Esperanza Recruiting
Santiago de Compostela, Galicia, Spain, 15705
Contact: Álvaro Hermida, MD, PhD    0034 981 552 200    alvaro.hermida.ameijeiras@sergas.es   
Sponsors and Collaborators
IInstituto Gallego de Medicina Vascular
Investigators
Study Director: Alvaro Hermida, MD, PhD Hospital Nuestra Señora de la Esperanza

Responsible Party: IInstituto Gallego de Medicina Vascular
ClinicalTrials.gov Identifier: NCT02919059     History of Changes
Other Study ID Numbers: ESR-14-10158
First Posted: September 29, 2016    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by IInstituto Gallego de Medicina Vascular:
Diabetes Mellitus, Type 2
DM

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Anti-Arrhythmia Agents
Hypoglycemic Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors