Overview

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

Status:
Completed
Trial end date:
2018-03-01
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Jichi Medical University
Collaborators:
Boehringer Ingelheim
Eli Lilly and Company
Treatments:
Angiotensin Receptor Antagonists
Empagliflozin
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