UMIN-CTR Clinical Trial

Basic information
Public title	Prospective comparison of Luseogliflozin and alpha-glucosidase inhibitor on the management of diabetic patients with chronic heart failure and preserved left-ventricular ejection fraction
Acronym	Prospective comparison of Luseogliflozin and alpha-glucosidase inhibitor on the management of diabetic patients with chronic heart failure and preserved left-ventricular ejection fraction
Scientific Title	Prospective comparison of Luseogliflozin and alpha-glucosidase inhibitor on the management of diabetic patients with chronic heart failure and preserved left-ventricular ejection fraction
Scientific Title:Acronym	Prospective comparison of Luseogliflozin and alpha-glucosidase inhibitor on the management of diabetic patients with chronic heart failure and preserved left-ventricular ejection fraction
Region	Japan

Condition
Condition	heart failure
Classification by specialty	Cardiology Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of luseogliflozin on LV load in type 2 diabetic patients with heart failure with preserved ejection fraction compared to an alpha-glucosidase inhibitor, voglibose.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change in BNP at 12 weeks
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	SGLT2 inhibitor, luseogliflozin 5 mg once a day
Interventions/Control_2	alpha-glucosidase inhibitor, voglibose 0.3mg three times/day
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	40 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	1) Type 2 diabetic patients with LV ejection fraction > 45% and a symptom of heart failure 2) Inadequately controlled type 2 diabetic patients who have received alimentary therapy, exercise therapy, a lifestyle modification program, and hypoglycemic medications 3) Age >40 years and <75 years 4) Patients from whom a written informed consent was obtained
Key exclusion criteria	1) BNP <35 pg/ml 2) Patients receiving alpha-glucosidase inhibitors, SGLT2 inhibitors, glinides, high-dose sulfonylurea 3) Patients with renal insufficiency (eGFR< 30 ml/min/1.73m2) 4) LVEF<45% 5) Patients with history of severe ketoacidosis, diabetic coma within six months 6) Patients with serious infection and severe trauma, and perioperative patients 7) Type 1 diabetes mellitus 8) Poorly controlled type2 diabetic patients (HbA1c > 9.0%) 9) Uncontrolled hypertensive patients (systolic blood pressure >160mmHg) 10) Patients with history of stroke, myocardial infarction and severe cardiovascular disease with hospitalization within six months 11) Pregnant women and breast-feeding women 12) Patients with allergy for test drugs 13) Patients who is not suitable to this study due to medical reasons
Target sample size	190

Research contact person
Name of lead principal investigator	1st name Hiroshi Middle name Last name Ito
Organization	Okayama University Graduate School of. Medicine, Dentistry and Pharmaceutical Sciences
Division name	Cardiovascular Medicine
Zip code	700-8558
Address	2-5-1, Shikata-cho, Kita-ku, Okayama
TEL	086-235-7351
Email	itomd@md.okayama-u.ac.jp

Public contact
Name of contact person	1st name Toru Middle name Last name Miyoshi
Organization	Okayama University Graduate School of. Medicine, Dentistry and Pharmaceutical Sciences
Division name	Cardiovascular Medicine
Zip code	700-8558
Address	2-5-1 Shikada-cho Kita-ku Okayama
TEL	086-235-7351
Homepage URL
Email	miyoshit@cc.okayama-u.ac.jp

Sponsor
Institute	Cardiovascular Medicine Okayama University Graduate School of. Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department

Funding Source
Organization	Novartis
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	Ethics committee of Okayama University
Address	2-5-1 Shikada-cho Kita-ku Okayama
Tel	086-235-6503
Email	mae6605@adm.okayama-u.ac.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	2015 Year 09 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	Completed
Date of protocol fixation	2015 Year 09 Month 30 Day
Date of IRB	2015 Year 09 Month 30 Day
Anticipated trial start date	2015 Year 10 Month 01 Day
Last follow-up date	2018 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 07 Month 23 Day
Last modified on	2020 Year 01 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021301