UMIN-CTR Clinical Trial

Public title

Study of the beneficial effect of Canagliflozin on nocturnal home BP in Japanese T2DM patients(SHIFT-J STUDY)

Acronym

Study of the beneficial effect of Canagliflozin on nocturnal home BP in Japanese T2DM patients(SHIFT-J STUDY)

Scientific Title

Study of the beneficial effect of Canagliflozin on nocturnal home BP in Japanese T2DM patients(SHIFT-J STUDY)

Scientific Title:Acronym

Study of the beneficial effect of Canagliflozin on nocturnal home BP in Japanese T2DM patients(SHIFT-J STUDY)

Region

Japan

Condition

Type 2 diabetes mellitus patients with hypertension

Classification by specialty

Cardiology

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the effects on nocturnal home blood pressure in type 2 diabetes mellitus patients with hypertension accompanied by nocturnal hypertension who are taking antihypertensive agents and who have poorly controlled blood glucose with pharmacotherapy using existing hypoglycemic agents when divided into a group additionally administered Canagliflozin, an SGLT2 inhibitor (Canagliflozin Addition Group), and a group given an increased dosage of hypoglycemic agents or additional administration of another hypoglycemic drug (Hypoglycemic Treatment Enhancement Group), which was the control group.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Nocturnal blood pressure changes from treatment period 0 weeks to treatment period 8 weeks

Key secondary outcomes

Rates of change for the following items from treatment period 0 weeks to treatment period 8 weeks
(1) Blood pressure (systolic blood pressure/diastolic blood pressure and pulse rate)
-Home blood pressure parameters (early morning, before bedtime, and nocturnal)
-Clinic blood pressure
-Blood pressure variability

(2) Metabolism-related factors
-HbA1c
-Body weight and BMI
-Lipids and uric acid

(3) NT-proBNP, ANP and urinary microalbumin

Safety evaluation items
-Adverse events and side effects
-Clinical test values

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

The Hypoglycemic Treatment Enhancement Group received an increased dose of hypoglycemic agents (one agent) with diabetes treatment and antihypertensive treatment already being received or were additionally administered a hypoglycemic agent (one agent other than an SGLT2 inhibitor). Antihypertensive treatment, nutritional and exercise therapy were continued as usual and each patient's course was observed over 8 weeks.

Interventions/Control_2

The Canagliflozin Addition Group was orally administered 100 mg of Canagliflozin (Canaglu(R) tablets), an SGLT2 inhibitor, once per day before or after breakfast in addition to diabetes and antihypertensive treatment already being received. Antihypertensive treatment, nutritional and exercise therapy were continued as usual and each patient's course was observed over 8 weeks.

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

(1) Directly gave written consent to participate in this study
(2) Aged 20 years or older at time of giving consent
(3) Sex: Male or female
(4) Treatment classification: Outpatient

(Selection Criteria for Provisional Enrollment)
(1) At the provisional enrollment, hypertension patients who meet all of the following requirements
-Taking antihypertensive agents (at least past 3 months, patients with no history of changing antihypertensive medication)
-As a rule, no changes in antihypertensive agent medication or dosage during the study
-Clinic sitting systolic blood pressure of 130 - 159 mmHg and diastolic blood pressure of 80 - 99 mmHg
(2) Type 2 diabetes mellitus patients with hemoglobin A1c (HbA1c)* of >=6.5% <10% when consent was obtained
*Refers to HbA1c values measured at provisional enrollment or within 4 weeks before provisional enrollment.
(3) Increased hypoglycemic dosage or additional administration of another hypoglycemic agent is being considered due to poor control (HbA1c below target value)
(4) Taking one hypoglycemic agent (excluding combination drugs)

(Selection Criteria for Enrollment)
(1) During observation, mean systolic nocturnal home blood pressure (supine) (hereinafter: "nocturnal blood pressure") measured over 5 days before coming to hospital in treatment period week 0 was at least 115mmHg

Key exclusion criteria

(Exclusion Criteria)
(1) Taking SGLT2 inhibitors
(2) Prescribed insulin
(3) Taking diuretics
(4) Prescribed GLP-1 receptor agonists
(5) History of hypersensitivity due to SGLT2 inhibitors
(6) History of cerebral infarction
(7) Advanced renal dysfunction or end-stage renal failure and undergoing dialysis
(8) Pregnant or possibility of pregnancy
(9) Breastfeeding
(10) Participating in another clinical study or trial (excluding observational studies)
(11) Deemed ineligible for another reason by the study doctor
(Exclusion Criteria for Enrollment)
(1) Deemed difficult to continue in the study by the study doctor during observation due to home blood pressure measurement state
(2) Severe adverse event observed during observation period
(3) Deemed ineligible for another reason during the observation period by the study doctor

Target sample size

100

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, Tochigi, Japan

TEL

0285-58-7538

Email

kkario@jichi.ac.jp

Name of contact person

1st name
Middle name
Last name	SHIFT-J research group

Organization

Mebix, Inc.

Division name

SHIFT-J research group

Zip code

Address

1-28, Toranomon 4 chome, Minato-ku, Tokyo

TEL

03-4362-4504

Homepage URL

Email

shift-j@mebix.co.jp

Institute

Jichi Medical University School of Medicine

Institute

Department

Personal name

Organization

Mitsubishi Tanabe Pharma Corporation.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

桜井内科クリニック(静岡県)、医療法人和紘会すみ循環器内科クリニック(大分県)、医療法人社団健貴会菊間クリニック(千葉県)、医療法人恵樹会いたばし糖尿病内科皮フ科クリニック(茨城県)、刀根クリニック(三重県)、お日さまクリニック(高知県)

Date of disclosure of the study information

2016

Year

08

Month

04

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

08

Month

01

Day

Date of IRB

Anticipated trial start date

2016

Year

08

Month

10

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

2017

Year

10

Month

23

Day

Date analysis concluded

Other related information

Registered date

2016

Year

08

Month

04

Day

Last modified on

2017

Year

12

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026635