UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Luseogliflozin Ehime Diabetes Study (LED study)
Title of the study (Brief title)	LED Study
Region	Japan

Condition
Condition	Type 2 Diabetes Mellitus
Classification by specialty	Hepato-biliary-pancreatic medicine Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the changes of energy intake, eating behavior, HbA1c and Weight after administration of luseogliflozin.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase IV

Assessment
Primary outcomes	The change of HbA1c, fasting glucose level, energy intake, and eating behavior. The association between energy intake and HbA1c.
Key secondary outcomes	Weight, Abdominal circumference, Lipid profile, liver function test, renal function, heart function, and organ damage marker. The severity of nocturia and sleep time. The frequency of hypoglycemia. The change of intestinal bacterial flora.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Luseogliflozin 214 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	20 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	Body mass Index more than 23 More than estimated GFR 30 Written informed consent was obtained from all patients enrolled in the this Study
Key exclusion criteria	contraindication of Luseogliflozin, type 1 diabetes mellitus, cancer, history of severe hypoglycemia, ketoacidosis, skin disease during treatment, repeated genital infection and urinary tract infection Sleep disorder related to the otolaryngology disease, neurological disease, hypothyroidism and acromegaly. Severe hepatic insufficiency defined as aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3x ULN. Total bilirubin >2.0 mg/dL . Positive serologic evidence of current infectious liver disease including Hepatitis B viral antibody IgG, Hepatitis B viral antibody IgM, Hepatitis B surface antigen and Hepatitis C virus antibody. History of unstable or rapidly progressing renal disease. Volume depleted patients. Recent Cardiovascular Events in a patient: Acute Coronary Syndrome (ACS) within 2 months prior to enrolment, Hospitalization for unstable angina or acute myocardial infarction within 2 months prior to enrolment, Acute Stroke or TIA within two months prior to enrolment, and Less than two months post coronary artery revascularization Pregnant or breastfeeding patients. Congestive heart failure defined as New York Heart Association (NYHA) class IV, unstable or acute congestive heart failure. Patients using other SGLT2 inhibitor.
Target sample size	30

Research contact person
Name of lead principal investigator	Shinya Furukawa
Organization	Ehime University Graduate School of Medicine
Division name	Department of Epidemiology and Preventive Medicine
Address	Shitsukawa, Toon, Ehime, Japan
TEL	0899605283
Email	shinfuru@m.ehime-u.ac.jp

Public contact
Name of contact person	Shinya Furukawa
Organization	Ehime University Graduate School of Medicine
Division name	Department of Epidemiology and Preventive Medicine
Address	Shitsukawa, Toon, Ehime, Japan
TEL	0899605283
Homepage URL
Email	shinfuru@m.ehime-u.ac.jp

Sponsor
Institute	Department of Epidemiology and Preventive Medicine, Ehime University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Taisho Toyama Phama
Organization
Division
Category of Funding Organization	Profit organization
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	2016 Year 08 Month 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 05 Month 01 Day
Anticipated trial start date	2016 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete	2019 Year 03 Month 31 Day
Date analysis concluded	2019 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 08 Month 17 Day
Last modified on	2019 Year 02 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027237