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

NCT03050229 | Completed Phase 4 DMC

• 1 other identifier: 1245-131
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 12

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

Conditions

Nocturnal Hypertension; T2DM (Type 2 Diabetes Mellitus)

Outcome Measures

Primary Outcomes (1)

• Reduction of nocturnal blood pressure measured by ABPM

  12 weeks

Secondary Outcomes (22)

• 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 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

Study Arms (2)

Empagliflozin

EXPERIMENTAL

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.

Drug: Empagliflozin

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Empagliflozin DRUG

Empagliflozin 10mg/day once daily before or after breakfast

Also known as: Jardiance

Empagliflozin

Placebo DRUG

Placebo once daily before or after breakfast

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jichi Medical University: lead
• Boehringer Ingelheim: collaborator
• Eli Lilly and Company: collaborator

Study Sites (12)

Fukuoka University Chikushi Hospital

Fukuoka, Japan

Location

Kotake Hospital

Fukuoka, Japan

Location

Onga Hospital

Fukuoka, Japan

Location

Ishiguro Clinic

Gifu, Japan

Location

Higashiagatsuma-machi National Health Insurance Clinic

Gunma, Japan

Location

Katsuya Iin

Hyōgo, Japan

Location

Minamisanriku Hospital

Miyagi, Japan

Location

Shibuya Clinic

Saitama, Japan

Location

International University of Health and Welfare Hospital

Tochigi, Japan

Location

Jichi Medical University hospital

Tochigi, Japan

Location

Utsunomiya higashi hospital

Tochigi, Japan

Location

Kato Clinic

Tokyo, Japan

Location

Related Publications (1)

• 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.

  PMID: 30586745 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Kazuomi Kario, MD

  Jichi Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor & Chairman, Division of Cardiovascular Medicine, Department of Medicine

Study Record Dates

• First Submitted: December 26, 2016
• First Posted: February 10, 2017
• Study Start: January 1, 2017
• Primary Completion: October 1, 2017
• Study Completion: March 1, 2018
• Last Updated: March 27, 2018

Record last verified: 2018-03

Locations

JP (12)