UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of dapagliflozin on blood pressure, cardiac function, visceral fat in type 2 diabetes mellitus patients with hypertension.
Title of the study (Brief title)	Effect of dapagliflozin on blood pressure, cardiac function, visceral fat in type 2 diabetes mellitus patients with hypertension.
Region	Japan

Condition
Condition	type 2 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aimed to investigate change of brain natriuretic peptide(BNP), atrial natriuretic peptide(ANP) and change of blood pressure by ABPM in TDM2 with hypertension.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Change of serum ANP/BNP value comparing with baseline.
Key secondary outcomes	change of fat area in the abdominal cavity comparing with baseline change of HbA1c comparing with baseline change of autonomic nerve function (heart rate variability, QT interval on electrocardiogram) change of fluctuation of blood pressure in day physical measurement(weight, waist circumference) echocardiogram blood test (blood glucose, HbA1c, uric acid, insulin, 1.5AG, total ketone body, renin, aldosterone) urinalysis (sodium, potassium, glucose, creatinine, uric acid)

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	dapagliflozin
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	patients T2DM patients with hypertension 1)HbA1C higher than6.5% but lowre than 9% 2)BNP 30-200pg ml 3)acceptable for combination therapy with other anti hyperglycemic agents 4)Blood Pressure higher than 130 and or higher than 85mmHg with anti hypertension agents 5)acceptable for therapy with lipid lowering drug and antihyperuricemic drug 6)20-75years 7)serum creatinine lower than 1.5mg dl 8)higher than BMI18.5 9)subjects who can measure by dualscan 10)subjects who give consent document about participation in the clinical study
Key exclusion criteria	1) Patients who are Type I or Secondary diabetic mellitus 2) Patients who are treating with Insulin theraphy at the time of study initiation 3) Patients who are severe infectious disease, perioperative, and severe trauma 4)Patients who are pregnant, lactating, and possibly pregnant women and those planning to become pregnant 5)Patients with myocardial infarction, angina pectoris, cerebral stroke, or cerebral infarction before 3 month 6) patients with Arrhythmia,atrial fibrillation 7) Patients with a history of hypersensitivity to investigational drugs 8) Patients with cancer 9) Patients who receive steroid therapy with inflammatory affection 10) Patients whom doctor judges as ineligible to this study
Target sample size	30

Research contact person
Name of lead principal investigator	Izuru Masuda
Organization	Takeda Hospital
Division name	Medical Examination Center
Address	3F, Nihonseimei Kyoto Santetsu Bldg 608 Higashi-Shiokoji-cho, Shimogyoku, Kyoto, Japan
TEL	075-365-0825
Email	imasuda@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Izuru Masuda
Organization	Takeda Hospital
Division name	Medical Examination Center
Address	3F, Nihonseimei Kyoto Santetsu Bldg 608 Higashi-Shiokoji-cho, Shimogyoku, Kyoto,
TEL	075-365-0825
Homepage URL
Email	imasuda@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Takeda Hospital Medical Examination Center
Institute
Department

Funding Source
Organization	Japan Vascular Disease Research Foundation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor	Ijinkai Takeda Hospital
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	2014 Year 09 Month 18 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2014 Year 09 Month 18 Day
Anticipated trial start date	2014 Year 09 Month 19 Day
Last follow-up date	2015 Year 02 Month 28 Day
Date of closure to data entry	2015 Year 06 Month 30 Day
Date trial data considered complete	2015 Year 11 Month 23 Day
Date analysis concluded	2015 Year 12 Month 17 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 09 Month 18 Day
Last modified on	2016 Year 09 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017635