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

T2DM (Type 2 Diabetes Mellitus) Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03050229
• Other study ID #: 1245-131
• Status: Completed
• Phase: Phase 4
• First received: December 26, 2016
• Last updated: March 25, 2018
• Start date: January 2017
• Est. completion date: March 2018

Study information

• Verified date: March 2018
• Source: Jichi Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: March 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hypertension
• Nocturnal Hypertension
• T2DM (Type 2 Diabetes Mellitus)

Intervention

Drug:
• Empagliflozin
Empagliflozin 10mg/day once daily before or after breakfast
• Placebo
Placebo once daily before or after breakfast

Locations

Country	Name	City	State
Japan	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	Hyogo
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

Sponsors (3)

Lead Sponsor	Collaborator
Jichi Medical University	Boehringer Ingelheim, Eli Lilly and Company

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of nocturnal blood pressure measured by ABPM		12 weeks
Secondary	Reduction of Blood pressure measured by ABPM -24h Blood Pressure		12 weeks
Secondary	Reduction of Blood pressure measured by ABPM -Daytime Blood Pressure		12 weeks
Secondary	Reduction of Blood pressure measured by ABPM -Minimum nocturnal Blood Pressure		12 weeks
Secondary	Reduction of Blood pressure measured by ABPM -Nocturnal blood pressure variability		12 weeks
Secondary	Reduction of Metabolism-related factors -HbA1c		12 weeks
Secondary	Reduction of Metabolism-related factors -body weight		12 weeks
Secondary	Reduction of Metabolism-related factors -BMI		12 weeks
Secondary	Reduction of Metabolism-related factors -lipids		12 weeks
Secondary	Reduction of Metabolism-related factors -uric acid		12 weeks
Secondary	Reduction of Metabolism-related factors -HOMA-R		12 weeks
Secondary	Reduction of Metabolism-related factors -HOMA-beta		12 weeks
Secondary	Change in Sleep efficacy -Sleep scale (Athens insomnia scale)		12 weeks
Secondary	Change in Sleep efficacy -Frequency of nocturnal awakening		12 weeks
Secondary	Change in Sleep efficacy -Frequency of nocturia		12 weeks
Secondary	Changes in the measures of circulating volume -Plasma NT-proBNP		12 weeks
Secondary	Changes in the measures of circulating volume -ANP		12 weeks
Secondary	Changes in the measures of organ damage -Urinary albumin/creatinine excretion ratio		12 weeks
Secondary	Changes in the measures of organ damage -Urinary Na/K		12 weeks
Secondary	Changes in the measures of organ damage -eGFR		12 weeks
Secondary	Changes in the measures of organ damage -cystatinC		12 weeks
Secondary	The correlation between blood pressure and blood glucose control		12 weeks
Secondary	The correlation between blood pressure and body weight		12 weeks