UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of the beneficial effect of Canagliflozin on nocturnal home BP in Japanese T2DM patients(SHIFT-J STUDY)
Title of the study (Brief title)	Study of the beneficial effect of Canagliflozin on nocturnal home BP in Japanese T2DM patients(SHIFT-J STUDY)
Region	Japan

Condition
Condition	Type 2 diabetes mellitus patients with hypertension
Classification by specialty	Cardiology Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
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

Base
Study type	Interventional

Study design
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

Intervention
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

Eligibility
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

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, Tochigi, Japan
TEL	0285-58-7538
Email	kkario@jichi.ac.jp

Public contact
Name of contact person	SHIFT-J research group
Organization	Mebix, Inc.
Division name	SHIFT-J research group
Address	1-28, Toranomon 4 chome, Minato-ku, Tokyo
TEL	03-4362-4504
Homepage URL
Email	shift-j@mebix.co.jp

Sponsor
Institute	Jichi Medical University School of Medicine
Institute
Department

Funding Source
Organization	Mitsubishi Tanabe Pharma Corporation.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	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)

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 04 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 08 Month 01 Day
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

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Publication of results	Unpublished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

Management information
Registered date	2016 Year 08 Month 04 Day
Last modified on	2017 Year 12 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026635