UMIN-CTR Clinical Trial

Basic information
Public title	Effects of Luseogliflozin on Left Ventricular Diastolic Function in Patients with Type 2 Diabetes and Established Cardiovascular Disease
Acronym	Effects of Luseogliflozin on Left Ventricular Diastolic Function in Patients with Type 2 Diabetes and Established Cardiovascular Disease
Scientific Title	Effects of Luseogliflozin on Left Ventricular Diastolic Function in Patients with Type 2 Diabetes and Established Cardiovascular Disease
Scientific Title:Acronym	Effects of Luseogliflozin on Left Ventricular Diastolic Function in Patients with Type 2 Diabetes and Established Cardiovascular Disease
Region	Japan

Condition
Condition	The patients with type 2 diabetes and cardiovascular disease
Classification by specialty	Cardiology Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of luseogliflozin, an inhibitor of sodium-glucose cotransporter 2 (SGLT2), on left ventricular (LV) diastolic function in patients with type 2 diabetes mellitus (T2DM) and cardiovascular disease (CVD)
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The change in the septal E/e' ratio as a parameter of LV diastolic function between before and after the start of the luseogliflozin treatment
Key secondary outcomes	The change in various parameters in echocardiogram between before and after the start of the luseogliflozin treatment

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	Oral administration of 2.5mg luseogliflozin once a day for 24 weeks
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	30 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	1. Provide written informed concent 2. Aged >=30, <75 at consent 3. Type 2 diabetes mellitus 4. Grycated hemoglobin (HbA1c) (NGSP) of >= 6.5%, < 10.0% 5. previous history of any cardiovascular diseases 6. No experience of SGLT2 inhibitors
Key exclusion criteria	already taking an SGLT2 inhibitor, age < 30 years or >= 75 years, diagnosis of type 1 diabetes or insulin-dependent diabetes, symptomatic heart failure (NYHA II-IV), severe renal dysfunction (eGFR < 45 mL/min/1.73 m2), severe liver dysfunction (over 3* upper limit of normal), diabetic ketoacidosis or diabetic coma the presence of malignancy.
Target sample size	25

Research contact person
Name of lead principal investigator	1st name Yujiro Middle name Last name Ina
Organization	Saiseikai Fukuoka General Hospital
Division name	Department of Diabetes
Zip code	810-0001
Address	Tenjin 1-3-46, Fukuoka, Chuo-ku, Fukuoka, Japan
TEL	092-771-8151
Email	yujiroiiii@yahoo.co.jp

Public contact
Name of contact person	1st name Yujiro Middle name Last name Ina
Organization	Saiseikai Fukuoka General Hospital
Division name	Department of Diabetes
Zip code	810-0001
Address	Tenjin 1-3-46, Fukuoka, Chuo-ku, Fukuoka, Japan
TEL	0927718151
Homepage URL
Email	yujiroiiii@yahoo.co.jp

Sponsor
Institute	Saiseikai Fukuoka General Hospital
Institute
Department

Funding Source
Organization	N/A
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	Saiseikai Fukuoka General Hospital
Address	Tenjin 1-3-46, Fukuoka, Chuo-ku, Fukuoka, Japan
Tel	0927718151
Email	yujiroiiii@yahoo.co.jp

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	2020 Year 05 Month 19 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	25
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	2015 Year 06 Month 01 Day
Date of IRB	2019 Year 07 Month 01 Day
Anticipated trial start date	2015 Year 07 Month 01 Day
Last follow-up date	2020 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 05 Month 18 Day
Last modified on	2020 Year 05 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046151