UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of SGLT2 inhibitor on diabetic cardiac autonomic neuropathy
Title of the study (Brief title)	The effect of SGLT2 inhibitor on diabetic cardiac autonomic neuropathy
Region	Japan

Condition
Condition	diabetes mellitus
Classification by specialty	Cardiology Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Diabetic cardiac autonomic neuropathy (CAN) is difficult to benefit from cardiac rehabilitation in poorly controlled diabetic patients. We aim to reveal whether the addition of SGLT2 inhibitors improves diabetic CAN.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Heart rate recovery after exercise, heart rate variability parameters after three months of SGLT2 inhibitor treatment
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	Adiministration of SGLT2 inhibitors (empagliflozin 10mg/day or tofogliflozin 20mg/day) for three months of phase II cardiac rehabilitation
Interventions/Control_2	Adiministration of diabetic medication other than SGLT2 inhibitors for three months of phase II cardiac rehabilitation
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	90 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Diagnosed as type 2 diabetes mellitus with fasting blood glucose >=126mg/dL (or casual blood glucose >=200mg/dL) and HbA1c >=6.5% (2) HbA1c >=7.0% at the beginning of cardiac rehabilitation (3) Age >=20 years old and <90 years old (4) Providing written informed consent on voluntary basis
Key exclusion criteria	(1) History of SGLT2 inhibitor treatment (2) Associated with severe renal dysfunction (3) Associated with respiratory disease (4) History of cerebral infarction (5) History of urinary / genital infection (6) Women in pregnancy or at risk of becomming pregnant (7) Breast-feeding woment (8) Patients whom researchers rule out as prropriate subjects
Target sample size	200

Research contact person
Name of lead principal investigator	Miyu Tajima
Organization	University of Tokyo Hospital
Division name	Cardiovascular department
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL	03-3815-5411
Email	mtajima-tky@umin.ac.jp

Public contact
Name of contact person	Miyu Tajima
Organization	Sakakibara Heart Institute
Division name	Cardiovascular department
Address	3-16-1, Asahi-cho, Fuchu-shi, Tokyo
TEL	042-314-3111
Homepage URL
Email	mtajima-tky@umin.ac.jp

Sponsor
Institute	Sakakibara Heart Institute
Institute
Department

Funding Source
Organization	Sakakibara Heart Institute
Organization
Division
Category of Funding Organization	Self funding
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 07 Month 28 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 07 Month 28 Day
Anticipated trial start date	2018 Year 10 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 07 Month 27 Day
Last modified on	2018 Year 07 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038245