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Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000015203
Receipt No. 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

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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)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Institute Takeda Hospital Medical Examination Center
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017635


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