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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023649
Receipt No. R000027237
Scientific Title Luseogliflozin Ehime Diabetes Study (LED study)
Date of disclosure of the study information 2016/08/17
Last modified on 2019/02/12

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Basic information
Public title Luseogliflozin Ehime Diabetes Study (LED study)
Acronym LED Study
Scientific Title Luseogliflozin Ehime Diabetes Study (LED study)
Scientific Title:Acronym 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
1st name
Middle name
Last name Shinya Furukawa
Organization Ehime University Graduate School of Medicine
Division name Department of Epidemiology and Preventive Medicine
Zip code
Address Shitsukawa, Toon, Ehime, Japan
TEL 0899605283
Email shinfuru@m.ehime-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinya Furukawa
Organization Ehime University Graduate School of Medicine
Division name Department of Epidemiology and Preventive Medicine
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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
2016 Year 05 Month 01 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000027237

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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