UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021087 |
|---|---|
| Receipt number | R000024321 |
| Scientific Title | Effective and safe examination of Luseogliflozin for patients with fatty liver merger type II diabetes mellitus |
| Date of disclosure of the study information | 2016/02/18 |
| Last modified on | 2017/08/17 17:12:16 |
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Basic information
Public title
Effective and safe examination of Luseogliflozin for patients with fatty liver merger type II diabetes mellitus
Acronym
Effective and safe examination of Luseogliflozin for patients with fatty liver merger type II diabetes mellitus
Scientific Title
Effective and safe examination of Luseogliflozin for patients with fatty liver merger type II diabetes mellitus
Scientific Title:Acronym
Effective and safe examination of Luseogliflozin for patients with fatty liver merger type II diabetes mellitus
Region
| Japan |
Condition
Condition
fatty liver merger type II diabetes mellitus
Classification by specialty
| Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In the Japanese type II diabetes mellitus patients complicated with fatty liver, we examine efficacy and safety when we gave Luseogliflozin.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. It is the amount of change of 24 weeks after the dosage from a baseline of HbA1c
2.It is the rate of change of 24 weeks after the dosage from the baseline of the fat ratio in the liver
Key secondary outcomes
1.A blood sugar parameter:HbA1c(other than 24 weeks time),fasting plasma glucose, fasting CPR, fasting insulin, HOMA2-B, HOMA2-S
2.Liver function parameter:AST, ALT, gamma-GTP, ALP, LDH, Alb, T-Bil, TP
3.A metabolic parameter concerned:The weight, the stomach neighborhood, SBP, DBP, TG, LDL-C, HDL-C, TC, FFA, Non-HDL-C,uric acid
4.Others:Ratio,fatty liver,liver fibrosis evaluation score (FLI,FIB-4 index,NFS,AAR) of the subject whom metabolic syndrome improved,type IV collagen 7S,ferritin,Mac-2bp
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
Luseogliflozin tab. 2.5mg/day
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)The patient that an agreement was provided in a document than the person about the participation of this study
2) Age is a patient of (at the time of the document agreement acquisition) 20 years old or older
3) A patient having less than 8.5% of HbA1c (NGSP level) of the observation period more than 6.5%
4) The patient who carries out a constant diet cure continuously for more than start eight weeks for the observation period
5) The patient who does not use a diabetes therapeutic drug for more than start eight weeks for the observation period or the patient who uses diabetes therapeutic drug one drug or two drugs at a constant use, dose continuously for more than start eight weeks for the observation period
6) A patient (satisfying higher than following two items) that fatty liver was doubted by abdominal ultrasonography
Rise in echo level of the liver parenchyma
Upswing in liver kidney contrast
Deep part decrement
Obnubilation of the vessels in the liver
Key exclusion criteria
1)A diabetic except the type 2
2)The patient who corresponds to the taboo in the attached document of Luseogliflozin
3)The patient who is complicated with a serious renal damage
4)A patient with BMI less than 22kg/m2
5)Is the patients using Insulin, GLP-1 receptor agonist, SGLT2 inhibitor or Thiazolidine within eight weeks for observation period before initiation
6)Viral hepatitis (HBs antigen positive, HCV antibody positive), autoimmune hepatitis, the patients with primary biliary cirrhosis
7)Ascites, hepatic encephalopathy, the patients with the jaundice
8)The patients who put on strong magnetic substance and an electronic device including the body such as pacemakers
9)A pregnant woman, nursing mother, the patients who may be pregnant
10)The patients whom drinking that is the way the quantity of excessive alcohol goes is found in
11)By confirmation of the accumulation situation of intrahepatic iron by Chie Malle Coe T2*W1 of the MRI imaging, the evaluation of the intrahepatic fat ratio is clearly difficulty and the judged patient
12)The patients who, in addition, judged that study doctor attending was inadequate
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Osonoi |
Organization
Nakakinen Clinic
Division name
Internal medicine
Zip code
Address
745-5,Nakadai,Naka,Ibaraki
TEL
029-353-2800
t-osonoi@kensei-kai.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kensuke Ofuchi |
Organization
Practice part
Division name
Clinical Research Department
Zip code
Address
745-5,Nakadai,Naka,Ibaraki
TEL
029-353-2800
Homepage URL
k-ofuchi@kensei-kai.com
Sponsor or person
Institute
Nakakinen Clinic
Institute
Department
Personal name
Funding Source
Organization
Taisho Toyama Pharmaceutical Co., Ltd.
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
那珂記念クリニック（茨城県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 18 | 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 | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 06 | Month | 15 | Day |
Date trial data considered complete
| 2017 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 18 | Day |
Last modified on
| 2017 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024321
