UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	SGLT-2i and ARB combination therapy in patients with T2DM and nocturnal hypertension
Title of the study (Brief title)	SGLT-2i and ARB combination therapy in patients with T2DM and nocturnal hypertension (SACRA study)
Region	Japan

Condition
Condition	Patients with T2DM and nocturnal hypertension
Classification by specialty	Cardiology Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To explore the beneficial effects of 'empagliflozin + ARB' in comparison with 'placebo + ARB' on the reduction of nocturnal blood pressure in T2DM with hypertension
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Nocturnal BP measured by ABPM
Key secondary outcomes	1)Blood pressure (systolic blood pressure/diastolic blood pressure and pulse rate) -ABPM parameters (24-h BP, Daytime BP, minimum nocturnal BP, nocturnal BP variability) 2)Metabolism-related factors HbA1c, Body weight, Height, BMI, Lipids, Uric acid, HOMA-R, HOMA-beta 3)Sleep efficacy -Sleep scale (Athens insomnia scale) -Frequency of nocturnal awakening -Frequency of nocturia 4)Measures of circulating volume Plasma NT-proBNP, ANP 5)Measures of organ damage Urinary albumin/creatinine excretion ratio, Urinary Na/K, eGFR, cystatinC 6)Other measurement -The correlation between BP and blood glucose control -The correlation between BP and body weight

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Empagliflozin 10mg/day is administrated orally before or after breakfast for 12 weeks while continuing the existing treatment for hypertension (include ARB) and diabetes.
Interventions/Control_2	Placebo is administrated orally before or after breakfast for 12 weeks while continuing the existing treatment for hypertension (include ARB) and diabetes.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key 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
Key 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
Target sample size	176

Research contact person
Name of lead principal investigator	Kazuomi Kario
Organization	Jichi Medical University School of Medicine
Division name	Division of Cardiovascular,Medicine, Department of Medicine
Address	3311-1 Yakushiji, Shimotsuke-shi, Tochigi, Japan 329-0498
TEL	0285-58-7344
Email	kkario@jichi.ac.jp

Public contact
Name of contact person	The study secretariat
Organization	Satt Co.,Ltd
Division name	Clinical study promotion group
Address	2-12-8 Shinjuku,Shinjuku-ku,Tokyo,Japan
TEL	03-5312-5026
Homepage URL
Email	sacra@sa-tt.co.jp

Sponsor
Institute	Jichi Medical University School of Medicine
Institute
Department

Funding Source
Organization	Nippon Boehringer Ingelheim Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)	Eli Lilly and Company

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	自治医科大学（栃木県）、宇都宮東病院（栃木県）、南三陸病院（宮城県）、東吾妻診療所（群馬県）、加藤内科クリニック（東京都）、石黒クリニック（岐阜県）、勝谷医院（兵庫県）、おんが病院（福岡県）、小竹町立病院（福岡県）、しぶや医院（埼玉県）、

Other administrative information
Date of disclosure of the study information	2016 Year 12 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 11 Month 17 Day
Anticipated trial start date	2017 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 11 Month 24 Day
Last modified on	2018 Year 03 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028731