UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The differences in blood glucose management and affects on cardiac function of SGLT2 and DPP4 inhibitors
Title of the study (Brief title)	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	Shunsuke Kiuchi
Organization	Toho University Omori Medical Center
Division name	Department of Cardiovascular Medicine
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	Shunsuke Kiuchi
Organization	Toho University Omori Medical Center
Division name	Department of Cardiovascular Medicine
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2018 Year 01 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000036800