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

Phase 4

Completed

• Conditions: Nocturnal Hypertension; T2DM (Type 2 Diabetes Mellitus)
• Interventions: Drug: Placebo; Drug: Empagliflozin

• Registration Number: NCT03050229
• Lead Sponsor: Jichi Medical University

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.

Study Timeline

• Study First Submitted: 2016-12-26
• Study Start: 2017-01
• Study First Submitted QC: 2017-02-08
• Study First Posted: 2017-02-10
• Primary Completion: 2017-10
• Status Verified: 2018-03
• Study Completion: 2018-03
• Last Update Submitted: 2018-03-25
• Last Update Posted: 2018-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 174

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	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.
Empagliflozin	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.

Primary Outcome Measures

Name	Time	Method
Reduction of nocturnal blood pressure measured by ABPM	12 weeks

Secondary Outcome Measures

Name	Time	Method
Reduction of Metabolism-related factors -HOMA-beta	12 weeks
Change in Sleep efficacy -Sleep scale (Athens insomnia scale)	12 weeks
Change in Sleep efficacy -Frequency of nocturnal awakening	12 weeks
Change in Sleep efficacy -Frequency of nocturia	12 weeks
Reduction of Blood pressure measured by ABPM -24h Blood Pressure	12 weeks
Reduction of Blood pressure measured by ABPM -Daytime Blood Pressure	12 weeks
Reduction of Metabolism-related factors -uric acid	12 weeks
Reduction of Metabolism-related factors -HOMA-R	12 weeks
Reduction of Blood pressure measured by ABPM -Minimum nocturnal Blood Pressure	12 weeks
Reduction of Blood pressure measured by ABPM -Nocturnal blood pressure variability	12 weeks
Reduction of Metabolism-related factors -HbA1c	12 weeks
Reduction of Metabolism-related factors -body weight	12 weeks
Reduction of Metabolism-related factors -BMI	12 weeks
Reduction of Metabolism-related factors -lipids	12 weeks
Changes in the measures of circulating volume -Plasma NT-proBNP	12 weeks
Changes in the measures of circulating volume -ANP	12 weeks
Changes in the measures of organ damage -Urinary albumin/creatinine excretion ratio	12 weeks
Changes in the measures of organ damage -Urinary Na/K	12 weeks
Changes in the measures of organ damage -eGFR	12 weeks
The correlation between blood pressure and blood glucose control	12 weeks
The correlation between blood pressure and body weight	12 weeks
Changes in the measures of organ damage -cystatinC	12 weeks

Trial Locations

Locations (12)

Kotake Hospital; 🇯🇵 Fukuoka, Japan

Onga Hospital; 🇯🇵 Fukuoka, Japan

Ishiguro Clinic; 🇯🇵 Gifu, Japan

Higashiagatsuma-machi National Health Insurance Clinic; 🇯🇵 Gunma, Japan

Fukuoka University Chikushi Hospital; 🇯🇵 Fukuoka, Japan

Katsuya Iin; 🇯🇵 Hyogo, Japan

Minamisanriku Hospital; 🇯🇵 Miyagi, Japan

Shibuya Clinic; 🇯🇵 Saitama, Japan

Jichi Medical University hospital; 🇯🇵 Tochigi, Japan

Utsunomiya higashi hospital; 🇯🇵 Tochigi, Japan

International University of Health and Welfare Hospital; 🇯🇵 Tochigi, Japan

Kato Clinic; 🇯🇵 Tokyo, Japan