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
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
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
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
