UMIN-CTR Clinical Trial

Public title

SGLT-2i and ARB combination therapy in patients with T2DM and nocturnal hypertension

Acronym

SGLT-2i and ARB combination therapy in patients with T2DM and nocturnal hypertension
(SACRA study)

Scientific Title

SGLT-2i and ARB combination therapy in patients with T2DM and nocturnal hypertension

Scientific Title:Acronym

SGLT-2i and ARB combination therapy in patients with T2DM and nocturnal hypertension
(SACRA study)

Region

Japan

Condition

Patients with T2DM and nocturnal hypertension

Classification by specialty

Cardiology

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Kazuomi Kario

Organization

Jichi Medical University School of Medicine

Division name

Division of Cardiovascular,Medicine, Department of Medicine

Zip code

Address

3311-1 Yakushiji, Shimotsuke-shi, Tochigi, Japan 329-0498

TEL

0285-58-7344

Email

kkario@jichi.ac.jp

Name of contact person

1st name
Middle name
Last name	The study secretariat

Organization

Satt Co.,Ltd

Division name

Clinical study promotion group

Zip code

Address

2-12-8 Shinjuku,Shinjuku-ku,Tokyo,Japan

TEL

03-5312-5026

Homepage URL

Email

sacra@sa-tt.co.jp

Institute

Jichi Medical University School of Medicine

Institute

Department

Personal name

Organization

Nippon Boehringer Ingelheim Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Eli Lilly and Company

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）、

Date of disclosure of the study information

2016

Year

12

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2016

Year

11

Month

17

Day

Date of IRB

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

Other related information

Registered date

2016

Year

11

Month

24

Day

Last modified on

2018

Year

03

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028731