UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023649 |
|---|---|
| Receipt number | 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 15:09:37 |
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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
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
shinfuru@m.ehime-u.ac.jp
Sponsor or person
Institute
Department of Epidemiology and Preventive Medicine, Ehime University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027237
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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