UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The differecnces between SGLT2 and DPP4 inhibitors in blood glucose management and cardiac sympathetic nerve activity
Title of the study (Brief title)	The differences between SGLT2 and DPP4 inhibitors in cardiac sympathetic nerve activity
Region	Japan

Condition
Condition	Diabetes mellitus (DM) patients complicated with heart failure (HF)
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 sympathetic nerve activity in patients with DM and HF
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	blood glucose management
Key secondary outcomes	cardiac sympathetic nerve activity

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 we add the dosage of DPP4 inhibitor. This therapy will be continue for 6 months after the change, however, we stop this study 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 we add SGLT2 inhibitor on DPP4 inhibitor. This therapy will be continue for 6 months after the change, however, we stop this study 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	Out patients with DM and HF of NHYA classification of I - III who are administrated with sitagliptin. The dosage of sitagliptin does not change for 4 weeks or more. Bloo d 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 study Patients who may be thought to worse blood glucose management with the protocol of this study Patients with moderate or severe renal impairment (less than eGFR45) Patients with severe hepatic impairment (Child-Pugh classification C) Patients who were judged inappropriate as subjects of this study by investigators
Target sample size	40

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	2017 Year 04 Month 27 Day
Anticipated trial start date	2017 Year 06 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=R000036806