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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018996
Receipt No. R000021972
Scientific Title Study of the safety of SGLT-2 inhibitors for heart failure patients with type 2 diabetes mellitus
Date of disclosure of the study information 2015/09/14
Last modified on 2018/02/11

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Basic information
Public title Study of the safety of SGLT-2 inhibitors for heart failure patients with type 2 diabetes mellitus
Acronym SGLT-2 inhibitors for volume overload of heart failure patients with diabetes mellitus
Scientific Title Study of the safety of SGLT-2 inhibitors for heart failure patients with type 2 diabetes mellitus
Scientific Title:Acronym SGLT-2 inhibitors for volume overload of heart failure patients with diabetes mellitus
Region
Japan

Condition
Condition heart failure patients with type 2 diabetes mellitus
Classification by specialty
Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To observe how the administration of SGLT-2-i inhibitors (ipragliflozin) safely improve symptomatic volume overload of heart failure patients with diabetes mellitus
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The usage dose of loop, thiazides diuretics and tolvaptan at 4 weeks and 24 weeks.
Key secondary outcomes

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 Administration of ipragliflozin 12.5 mg once a day. When it is insufficiently effective, it can be increased to 50 mg once a day.
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 1) Type 2 diabetes with HbA1c >=7.0% and <12.0%
2) Physical findings of vloume overload
3) Loop diuretic administration of furosemide 20mg, azosemide 30mg or torasemide 4mg in a day
4) Written informed consent is obtained
Key exclusion criteria 1) Type 1 diabetes
2) With severe renal dysfunction (eGRF <30 mL/min or patient undergoing artificial dialysis)
3) Heart failure patient whose NYHA functional classification is IV
4) SGLT-2 inhibitor has been administered from admission to registration
5) Physicians and other staff have been deemed inappropriate for registration of this study
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Wataru Shimizu
Organization Nippon Medical School
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1-5, Sendagi, Bunkyo-ku, Tokyo Japan 113-8603
TEL 03-3822-2131
Email ykubota@nms.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiaki Kubota
Organization Nippon Medical School
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1-5, Sendagi, Bunkyo-ku, Tokyo Japan 113-8603
TEL 03-3822-2131
Homepage URL
Email ykubota@nms.ac.jp

Sponsor
Institute Nippon Medical School
Department of Cardiovascular Medicine
Institute
Department

Funding Source
Organization Nippon Medical School
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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
2015 Year 09 Month 14 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Completed
Date of protocol fixation
2014 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 09 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 09 Month 13 Day
Last modified on
2018 Year 02 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021972

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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