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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000032272
Receipt No. R000036800
Scientific Title The differences in blood glucose management and affects on cardiac function of SGLT2 and DPP4 inhibitors
Date of disclosure of the study information 2018/04/20
Last modified on 2018/10/16

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Basic information
Public title The differences in blood glucose management and affects on cardiac function of SGLT2 and DPP4 inhibitors
Acronym The differences between SGLT2 and DPP4 inhibitors in cardiac function
Scientific Title The differences in blood glucose management and affects on cardiac function of SGLT2 and DPP4 inhibitors
Scientific Title:Acronym The differences between SGLT2 and DPP4 inhibitors in cardiac function
Region
Japan

Condition
Condition Diabetes mellitus (DM) patients complicated with heart failure preserved ejection fraction (HFpEF)
Classification by specialty
Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The evaluation of blood glucose management and cardiac function in patients with DM and HFpEF
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Presence or absence of total/cardiovascular death, re-hospitalization of HF and worsening of DM
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 If blood glucose management with patients who were administrated with DPP4 inhibitor were more bad, strict diet exercise therapy is performed and DPP4 inhibitor is continued.
DPP4 inhibitors or SGLT2 inhibitors will be continue for 6 months after the change, however, we stop this examination if blood glucose manegement exacerbation will apear.
Interventions/Control_2 If blood glucose management with patients who were administrated with DPP4 inhibitor were more bad, strict diet exercise therapy is performed and DPP4 inhibitor is switched to SGLT2 inhibitor.
DPP4 inhibitors or SGLT2 inhibitors will be continue for 6 months after the change, however, we stop this examination if blood glucose manegement exacerbation will apear.
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
30 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria Outpatients with DM and HFpEF of NHYA classification of I - III
Medications (including DPP4 inhibitor) did not changed of dosage before 4 weeks from examincation start
Blood glucose management were worsening and patients who need to strict diet/exercise therapy or change medication.
Key exclusion criteria Pregnancy, breast-feeding, patients who may be pregnant, and patients who want pregnancy during the examination
Patients who may be thought to worse blood glucose management with the protocol of this examination.
Patients who are received with DPP 4 inhibitor, once a week.
Patients with moderate or severe renal impairment (less than eGFR 45)
Patients with severe hepatic impairment (Child-Pugh classification C)
Patients who were judged inappropriate as subjects of this examination by investigators
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shunsuke Kiuchi
Organization Toho University Omori Medical Center
Division name Department of Cardiovascular Medicine
Zip code
Address 6-11-1 Omorinishi, Ota-ku, Tokyo 143-8541
TEL 03-3762-4151
Email syunnsuke@med.toho-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shunsuke Kiuchi
Organization Toho University Omori Medical Center
Division name Department of Cardiovascular Medicine
Zip code
Address 6-11-1 Omorinishi, Ota-ku, Tokyo 143-8541
TEL 03-3762-4151
Homepage URL
Email syunnsuke@med.toho-u.ac.jp

Sponsor
Institute Toho University
Institute
Department

Funding Source
Organization Toho University Omori Medical Center, Department of Cardiovascular Medicine
Organization
Division
Category of Funding Organization Other
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
2018 Year 04 Month 20 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 Terminated
Date of protocol fixation
2018 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 01 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
2018 Year 04 Month 16 Day
Last modified on
2018 Year 10 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036800

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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