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

Jichi Medical University

Status and phase: Completed; Phase 4

Conditions: Nocturnal Hypertension; T2DM (Type 2 Diabetes Mellitus)

Treatments: Drug: Empagliflozin; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03050229

1245-131

Details and patient eligibility

About

To explore the beneficial effects of 'empagliflozin + ARB' in comparison with 'placebo + ARB' on the reduction of nocturnal blood pressure in T2DM with hypertension

Full description

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

Enrollment: 174 patients

Sex: All

Ages: 20+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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174 participants in 2 patient groups, including a placebo group

Empagliflozin

Experimental group

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.

Treatment:

Drug: Empagliflozin

Placebo

Placebo Comparator group

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.

Treatment:

Drug: Placebo