UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018996
Receipt number 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 16:01:04

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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 or person

Institute

Nippon Medical School
Department of Cardiovascular Medicine

Institute

Department

Personal name



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

Value
https://center6.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