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

NCT ID: NCT03050229

Last Updated: 2018-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 174 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2018-03-31

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.

Conditions

Nocturnal Hypertension; T2DM (Type 2 Diabetes Mellitus)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Empagliflozin

Intervention Type: DRUG

Empagliflozin 10mg/day once daily before or after breakfast

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo once daily before or after breakfast

Interventions

Empagliflozin

Empagliflozin 10mg/day once daily before or after breakfast

Intervention Type: DRUG

Placebo

Placebo once daily before or after breakfast

Intervention Type: DRUG

Other Intervention Names

Jardiance

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

Jichi Medical University

OTHER

Sponsor Role: lead

Responsible Party

Kazuomi Kario

Professor & Chairman, Division of Cardiovascular Medicine, Department of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kazuomi Kario, MD

Role: PRINCIPAL_INVESTIGATOR

Jichi Medical University

Locations

Fukuoka University Chikushi Hospital

Fukuoka, , Japan

Kotake Hospital

Fukuoka, , Japan

Onga Hospital

Fukuoka, , Japan

Ishiguro Clinic

Gifu, , Japan

Higashiagatsuma-machi National Health Insurance Clinic

Gunma, , Japan

Katsuya Iin

Hyōgo, , Japan

Minamisanriku Hospital

Miyagi, , Japan

Shibuya Clinic

Saitama, , Japan

International University of Health and Welfare Hospital

Tochigi, , Japan

Jichi Medical University hospital

Tochigi, , Japan

Utsunomiya higashi hospital

Tochigi, , Japan

Kato Clinic

Tokyo, , Japan

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 30586745 (View on PubMed)

Other Identifiers

1245-131

Identifier Type: -

Identifier Source: org_study_id