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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Unknown status
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Dapagliflozin 10 mg
Glimepiride 4 mg
Sponsored by
IInstituto Gallego de Medicina Vascular
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes Mellitus, Type 2, DM

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Nuestra Señora de la EsperanzaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dapagliflozin 10 mg

Glimepiride 4 mg

Arm Description

Dapagliflozin 10 mg once daily during 24 weeks

Glimepiride 4 mg once daily during 24 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
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.
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.
Effect of dapagliflozin relative to glimepiride at 24 weeks with inadequate glycemic control regarding augmentation index
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.

Full Information

First Posted
September 23, 2016
Last Updated
March 28, 2017
Sponsor
IInstituto Gallego de Medicina Vascular
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1. Study Identification

Unique Protocol Identification Number
NCT02919059
Brief Title
Study to Asses the Effect of Dapagliflozin on Central Blood Pressure Reduction.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 13, 2016 (Actual)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
August 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IInstituto Gallego de Medicina Vascular

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Diabetes Mellitus, Type 2, DM

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
159 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dapagliflozin 10 mg
Arm Type
Experimental
Arm Description
Dapagliflozin 10 mg once daily during 24 weeks
Arm Title
Glimepiride 4 mg
Arm Type
Active Comparator
Arm Description
Glimepiride 4 mg once daily during 24 weeks
Intervention Type
Drug
Intervention Name(s)
Dapagliflozin 10 mg
Other Intervention Name(s)
Dapagliflozin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Glimepiride 4 mg
Other Intervention Name(s)
Glimepiride
Intervention Description
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.
Primary Outcome Measure Information:
Title
Effect of dapagliflozin relative to glimepiride at 24 weeks of treatment period regarding central systolic blood pressure
Description
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
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Effect of dapagliflozin relative to glimepiride at 24 weeks regarding central systolic/diastolic blood pressure
Description
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.
Time Frame
24 weeks
Title
Effect of dapagliflozin relative to glimepiride at 24 weeks regarding central pulse pressure
Description
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.
Time Frame
24 weeks
Title
Effect of dapagliflozin relative to glimepiride at 24 weeks of treatment with inadequate glycemic control regarding 24 hours ambulatory systolic/diastolic blood pressure
Description
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.
Time Frame
24 weeks
Title
Type and number of Adverse events in patienteSafety and tolerability of dapagliflozin relative to glimepiride.
Description
Type and number of Adverse events to assess the safety and tolerability of dapagliflozin relative to glimepiride.
Time Frame
28 weeks
Title
Effect of dapagliflozin relative to glimepiride at 24 weeks with inadequate glycemic control regarding augmentation pressure
Description
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.
Time Frame
24 weeks
Title
Effect of dapagliflozin relative to glimepiride at 24 weeks with inadequate glycemic control regarding augmentation index
Description
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.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alvaro Hermida, MD, PhD
Phone
0034 981 552 200
Email
alvaro.hermida.ameijeiras@sergas.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alvaro Hermida, MD, PhD
Organizational Affiliation
Hospital Nuestra Señora de la Esperanza
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Nuestra Señora de la Esperanza
City
Santiago de Compostela
State/Province
Galicia
ZIP/Postal Code
15705
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Álvaro Hermida, MD, PhD
Phone
0034 981 552 200
Email
alvaro.hermida.ameijeiras@sergas.es

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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