SGLT-2i and ARB Combination Therapy in Patients With T2DM and Nocturnal Hypertension (SACRA Study)

March 25, 2018 updated by: Kazuomi Kario, Jichi Medical University
To explore the beneficial effects of 'empagliflozin + ARB' in comparison with 'placebo + ARB' on the reduction of nocturnal blood pressure in T2DM with hypertension

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study consists of a 8-week run-in period and a 12-week treatment period.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
174

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Fukuoka, Japan
        • Fukuoka University Chikushi Hospital
      • Fukuoka, Japan
        • Kotake Hospital
      • Fukuoka, Japan
        • Onga Hospital
      • Gifu, Japan
        • Ishiguro Clinic
      • Gunma, Japan
        • Higashiagatsuma-machi National Health Insurance Clinic
      • Hyogo, Japan
        • Katsuya Iin
      • Miyagi, Japan
        • Minamisanriku Hospital
      • Saitama, Japan
        • Shibuya Clinic
      • Tochigi, Japan
        • Jichi Medical University Hospital
      • Tochigi, Japan
        • International University of Health and welfare Hospital
      • Tochigi, Japan
        • Utsunomiya higashi hospital
      • Tokyo, Japan
        • Kato Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients who meet the following criteria at the start of treatment are eligible for the study:

  • Receiving stable treatment with anti-hypertensive including ARB for at least 8 weeks at baseline (0W).
  • Receiving stable anti-diabetic treatment with/without anti-diabetics for at least 8 weeks at baseline (0W).
  • HbA1c>=6.0%, <10%
  • Seated office SBP 130-159mmHg or DBP 80-99mmHg
  • Nocturnal hypertension (SBP>=115 mmHg) as measured by Home BP during 5days before baseline (0W).
  • Age>=20

Exclusion Criteria:

Patients who meet any of the following criteria are not eligible for the study:

  • History of hypersensitivity to empagliflozin
  • Breast-feeding, pregnant, possibly pregnant, or plan to become pregnant
  • Treated with insulin or SU
  • With renal dysfunction (eGFR<45mL/min/1.73m2)
  • With liver dysfunction (AST or ALT is 3 times higher than reference value)
  • Hypotension (systolic blood pressure < 90 mmHg)
  • With pituitary gland dysfunction or adrenal gland dysfunction
  • Heart failure patients whose NYHA class is IV
  • Deemed ineligible for the study due to another reason by investigator
  • History of diabetic ketoacidosis or diabetic come within 3 months before enrollment
  • History of Acute myocardial infarction, unstable angina, cerebrovascular disease, or transient ischemic attack within 3 months before enrollment
  • Patients who have undergone percutaneous transluminal coronary angioplasty (PCI) or coronary artery bypass graftin (CABG) within 3 months before enrollment
  • Patients received SGLT2 inhibitor within 8 weeks before enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Empagliflozin
Empagliflozin 10mg/day is administrated orally before or after breakfast for 12 weeks while continuing the existing treatment for hypertension (include AngiotensinII Receptor Blocker [ARB]) and diabetes.
Drug: Empagliflozin
Empagliflozin 10mg/day once daily before or after breakfast
Other Names:
  • Jardiance
Placebo Comparator: Placebo
Placebo is administrated orally before or after breakfast for 12 weeks while continuing the existing treatment for hypertension (include AngiotensinII Receptor Blocker [ARB]) and diabetes.
Drug: Placebo
Placebo once daily before or after breakfast

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Reduction of nocturnal blood pressure measured by ABPM
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Reduction of Blood pressure measured by ABPM -24h Blood Pressure
Time Frame: 12 weeks
12 weeks
Reduction of Blood pressure measured by ABPM -Daytime Blood Pressure
Time Frame: 12 weeks
12 weeks
Reduction of Blood pressure measured by ABPM -Minimum nocturnal Blood Pressure
Time Frame: 12 weeks
12 weeks
Reduction of Blood pressure measured by ABPM -Nocturnal blood pressure variability
Time Frame: 12 weeks
12 weeks
Reduction of Metabolism-related factors -HbA1c
Time Frame: 12 weeks
12 weeks
Reduction of Metabolism-related factors -body weight
Time Frame: 12 weeks
12 weeks
Reduction of Metabolism-related factors -BMI
Time Frame: 12 weeks
12 weeks
Reduction of Metabolism-related factors -lipids
Time Frame: 12 weeks
12 weeks
Reduction of Metabolism-related factors -uric acid
Time Frame: 12 weeks
12 weeks
Reduction of Metabolism-related factors -HOMA-R
Time Frame: 12 weeks
12 weeks
Reduction of Metabolism-related factors -HOMA-beta
Time Frame: 12 weeks
12 weeks
Change in Sleep efficacy -Sleep scale (Athens insomnia scale)
Time Frame: 12 weeks
12 weeks
Change in Sleep efficacy -Frequency of nocturnal awakening
Time Frame: 12 weeks
12 weeks
Change in Sleep efficacy -Frequency of nocturia
Time Frame: 12 weeks
12 weeks
Changes in the measures of circulating volume -Plasma NT-proBNP
Time Frame: 12 weeks
12 weeks
Changes in the measures of circulating volume -ANP
Time Frame: 12 weeks
12 weeks
Changes in the measures of organ damage -Urinary albumin/creatinine excretion ratio
Time Frame: 12 weeks
12 weeks
Changes in the measures of organ damage -Urinary Na/K
Time Frame: 12 weeks
12 weeks
Changes in the measures of organ damage -eGFR
Time Frame: 12 weeks
12 weeks
Changes in the measures of organ damage -cystatinC
Time Frame: 12 weeks
12 weeks
The correlation between blood pressure and blood glucose control
Time Frame: 12 weeks
12 weeks
The correlation between blood pressure and body weight
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jichi Medical University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eli Lilly and Company
Boehringer Ingelheim

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kazuomi Kario, MD, Jichi Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 26, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1245-131

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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