UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015203
Receipt number R000017635
Scientific Title Effect of dapagliflozin on blood pressure, cardiac function, visceral fat in type 2 diabetes mellitus patients with hypertension.
Date of disclosure of the study information 2014/09/18
Last modified on 2016/09/19 15:21:06

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Effect of dapagliflozin on blood pressure, cardiac function, visceral fat in type 2 diabetes mellitus patients with hypertension.

Acronym

Effect of dapagliflozin on blood pressure, cardiac function, visceral fat in type 2 diabetes mellitus patients with hypertension.

Scientific Title

Effect of dapagliflozin on blood pressure, cardiac function, visceral fat in type 2 diabetes mellitus patients with hypertension.

Scientific Title:Acronym

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

1st name
Middle name
Last name Izuru Masuda

Organization

Takeda Hospital

Division name

Medical Examination Center

Zip code


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

1st name
Middle name
Last name Izuru Masuda

Organization

Takeda Hospital

Division name

Medical Examination Center

Zip code


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 or person

Institute

Takeda Hospital Medical Examination Center

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


Related information

URL releasing protocol


Publication of results

Partially published


Result

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



Progress

Recruitment status

Preinitiation

Date of protocol fixation

2014 Year 09 Month 18 Day

Date of IRB


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


Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017635


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name