UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Tofogliflozin Reduces 24-h Ambulatory Blood Pressure in inpatients with Type 2 Diabetes and Hypertension
Title of the study (Brief title)	The Influence of Tofogliflozin on 24-h Ambulatory Blood Pressure
Region	Japan

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

Objectives
Narrative objectives1	SGLT-2 inhibitors lead to reduced systolic and diastolic blood pressure inpatients with type 2 diabetes. We investigated the efficacy and influence of tofogliflozin on 24h-blood pressure using 24-h Ambulatory Blood Pressure Monitoringin inpatinets with type 2 diabetes and hypertension. We also performed power spectrum analysis of heart rate variability before and after the administration of tofogliflozin.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	24h-blood pressure(systolic and diastolic) before and after the administration of 20mg tofogliflozin.
Key secondary outcomes	Holter electrocardiograph,power spectrum analysis,NT-proBNP and D-ROMs before and after the administration of tofogliflozin.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	ABPM was performed twice time at pretreatmentand posttreatment for 1week of tofogliflozin.
Interventions/Control_2
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)patient with type 2 diabetesand hypertension doing a hospitalizing for diabetes treatment 2)Patients treated with Angiotensin Receptor Blocker(ARB) and/or Angiotensin Converting Enzyme Inhibitors(ACE-I) for hypertension 3) SBP>140mmHg and/or DBP>90mmHg
Key exclusion criteria	1) Type 1 diabetes 2) Severe diabetic complications such as ketoacidosis 3) Severe renal dysfunction(estimated glomerular filtration rate [eGFR] < 30 mL/min/) 4) Pregnant or nursing women and those who might be pregnant 5) Chronic heart failure, 6) Haemodialysis, 7) A history of stroke and cardiovascular events, 8) Any patient whom the investigator judged to be inappropriate for this study.
Target sample size	20

Research contact person
Name of lead principal investigator	Yoshimasa Aso
Organization	Dokkyo Medical University
Division name	Endocrinology and Metabolism
Address	880, Kitakobayashi, Mibu, Shimotsugagun, Tochigi
TEL	0282-87-2150
Email	yaso@dokkyomed.ac.jp

Public contact
Name of contact person	Kunihiro Suzuki
Organization	Dokkyo Medical University
Division name	Endocrinology and Metabolism
Address	880, Kitakobayashi, Mibu, Shimotsugagun, Tochigi
TEL	0282-87-2150
Homepage URL
Email	kuni-s@dokkyomed.ac.jp

Sponsor
Institute	Dokkyo Medical University
Institute
Department

Funding Source
Organization	Dokkyo Medical University
Organization
Division
Category of Funding Organization	Self funding
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

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 05 Month 30 Day
Anticipated trial start date	2016 Year 06 Month 15 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry	2018 Year 03 Month 31 Day
Date trial data considered complete	2018 Year 04 Month 01 Day
Date analysis concluded	2018 Year 12 Month 31 Day

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

Management information
Registered date	2016 Year 06 Month 02 Day
Last modified on	2018 Year 03 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026024