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