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

Primary Purpose

Nocturnal Hypertension, T2DM (Type 2 Diabetes Mellitus)

Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Empagliflozin
Placebo
Sponsored by
Jichi Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nocturnal Hypertension

Eligibility Criteria

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

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

Sites / Locations

  • Fukuoka University Chikushi Hospital
  • Kotake Hospital
  • Onga Hospital
  • Ishiguro Clinic
  • Higashiagatsuma-machi National Health Insurance Clinic
  • Katsuya Iin
  • Minamisanriku Hospital
  • Shibuya Clinic
  • International University of Health and Welfare Hospital
  • Jichi Medical University hospital
  • Utsunomiya higashi hospital
  • Kato Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Empagliflozin

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Reduction of nocturnal blood pressure measured by ABPM

Secondary Outcome Measures

Reduction of Blood pressure measured by ABPM -24h Blood Pressure
Reduction of Blood pressure measured by ABPM -Daytime Blood Pressure
Reduction of Blood pressure measured by ABPM -Minimum nocturnal Blood Pressure
Reduction of Blood pressure measured by ABPM -Nocturnal blood pressure variability
Reduction of Metabolism-related factors -HbA1c
Reduction of Metabolism-related factors -body weight
Reduction of Metabolism-related factors -BMI
Reduction of Metabolism-related factors -lipids
Reduction of Metabolism-related factors -uric acid
Reduction of Metabolism-related factors -HOMA-R
Reduction of Metabolism-related factors -HOMA-beta
Change in Sleep efficacy -Sleep scale (Athens insomnia scale)
Change in Sleep efficacy -Frequency of nocturnal awakening
Change in Sleep efficacy -Frequency of nocturia
Changes in the measures of circulating volume -Plasma NT-proBNP
Changes in the measures of circulating volume -ANP
Changes in the measures of organ damage -Urinary albumin/creatinine excretion ratio
Changes in the measures of organ damage -Urinary Na/K
Changes in the measures of organ damage -eGFR
Changes in the measures of organ damage -cystatinC
The correlation between blood pressure and blood glucose control
The correlation between blood pressure and body weight

Full Information

First Posted
December 26, 2016
Last Updated
March 25, 2018
Sponsor
Jichi Medical University
Collaborators
Boehringer Ingelheim, Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT03050229
Brief Title
SGLT-2i and ARB Combination Therapy in Patients With T2DM and Nocturnal Hypertension (SACRA Study)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jichi Medical University
Collaborators
Boehringer Ingelheim, Eli Lilly and Company

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To explore the beneficial effects of 'empagliflozin + ARB' in comparison with 'placebo + ARB' on the reduction of nocturnal blood pressure in T2DM with hypertension
Detailed Description
The study consists of a 8-week run-in period and a 12-week treatment period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nocturnal Hypertension, T2DM (Type 2 Diabetes Mellitus)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
174 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Empagliflozin
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Empagliflozin
Other Intervention Name(s)
Jardiance
Intervention Description
Empagliflozin 10mg/day once daily before or after breakfast
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo once daily before or after breakfast
Primary Outcome Measure Information:
Title
Reduction of nocturnal blood pressure measured by ABPM
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Reduction of Blood pressure measured by ABPM -24h Blood Pressure
Time Frame
12 weeks
Title
Reduction of Blood pressure measured by ABPM -Daytime Blood Pressure
Time Frame
12 weeks
Title
Reduction of Blood pressure measured by ABPM -Minimum nocturnal Blood Pressure
Time Frame
12 weeks
Title
Reduction of Blood pressure measured by ABPM -Nocturnal blood pressure variability
Time Frame
12 weeks
Title
Reduction of Metabolism-related factors -HbA1c
Time Frame
12 weeks
Title
Reduction of Metabolism-related factors -body weight
Time Frame
12 weeks
Title
Reduction of Metabolism-related factors -BMI
Time Frame
12 weeks
Title
Reduction of Metabolism-related factors -lipids
Time Frame
12 weeks
Title
Reduction of Metabolism-related factors -uric acid
Time Frame
12 weeks
Title
Reduction of Metabolism-related factors -HOMA-R
Time Frame
12 weeks
Title
Reduction of Metabolism-related factors -HOMA-beta
Time Frame
12 weeks
Title
Change in Sleep efficacy -Sleep scale (Athens insomnia scale)
Time Frame
12 weeks
Title
Change in Sleep efficacy -Frequency of nocturnal awakening
Time Frame
12 weeks
Title
Change in Sleep efficacy -Frequency of nocturia
Time Frame
12 weeks
Title
Changes in the measures of circulating volume -Plasma NT-proBNP
Time Frame
12 weeks
Title
Changes in the measures of circulating volume -ANP
Time Frame
12 weeks
Title
Changes in the measures of organ damage -Urinary albumin/creatinine excretion ratio
Time Frame
12 weeks
Title
Changes in the measures of organ damage -Urinary Na/K
Time Frame
12 weeks
Title
Changes in the measures of organ damage -eGFR
Time Frame
12 weeks
Title
Changes in the measures of organ damage -cystatinC
Time Frame
12 weeks
Title
The correlation between blood pressure and blood glucose control
Time Frame
12 weeks
Title
The correlation between blood pressure and body weight
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kazuomi Kario, MD
Organizational Affiliation
Jichi Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fukuoka University Chikushi Hospital
City
Fukuoka
Country
Japan
Facility Name
Kotake Hospital
City
Fukuoka
Country
Japan
Facility Name
Onga Hospital
City
Fukuoka
Country
Japan
Facility Name
Ishiguro Clinic
City
Gifu
Country
Japan
Facility Name
Higashiagatsuma-machi National Health Insurance Clinic
City
Gunma
Country
Japan
Facility Name
Katsuya Iin
City
Hyogo
Country
Japan
Facility Name
Minamisanriku Hospital
City
Miyagi
Country
Japan
Facility Name
Shibuya Clinic
City
Saitama
Country
Japan
Facility Name
International University of Health and Welfare Hospital
City
Tochigi
Country
Japan
Facility Name
Jichi Medical University hospital
City
Tochigi
Country
Japan
Facility Name
Utsunomiya higashi hospital
City
Tochigi
Country
Japan
Facility Name
Kato Clinic
City
Tokyo
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
30586745
Citation
Kario K, Okada K, Kato M, Nishizawa M, Yoshida T, Asano T, Uchiyama K, Niijima Y, Katsuya T, Urata H, Osuga JI, Fujiwara T, Yamazaki S, Tomitani N, Kanegae H. Twenty-Four-Hour Blood Pressure-Lowering Effect of a Sodium-Glucose Cotransporter 2 Inhibitor in Patients With Diabetes and Uncontrolled Nocturnal Hypertension: Results From the Randomized, Placebo-Controlled SACRA Study. Circulation. 2019 Apr 30;139(18):2089-2097. doi: 10.1161/CIRCULATIONAHA.118.037076. Epub 2018 Nov 29.
Results Reference
derived

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

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