UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025808 |
|---|---|
| Receipt number | R000029679 |
| Scientific Title | Efficacy and safety of luseogliflozin in patient with type 2 diabetes complicated with hepatic dysfunction |
| Date of disclosure of the study information | 2017/01/23 |
| Last modified on | 2018/01/24 13:48:53 |
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Basic information
Public title
Efficacy and safety of luseogliflozin in patient with type 2 diabetes complicated with hepatic dysfunction
Acronym
Efficacy and safety of luseogliflozin in patient with type 2 diabetes complicated with hepatic dysfunction
Scientific Title
Efficacy and safety of luseogliflozin in patient with type 2 diabetes complicated with hepatic dysfunction
Scientific Title:Acronym
Efficacy and safety of luseogliflozin in patient with type 2 diabetes complicated with hepatic dysfunction
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of luseogliflozin in patient with type 2 diabetes complicated with hepatic dysfunction
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change and percent change in AST, ALT, gamma-GTP, and HbA1c from baseline to 52 weeks
Key secondary outcomes
1) Change in the following items from baseline to 12 and 24 weeks
- AST, ALT, gamma-GTP, HbA1c
2) Change in the following items from baseline to 12, 24, and 52 weeks
- Fasting plasma glucose, HOMA-beta, HOMA-IR
- Body weight, BMI, Waist circumference, and Blood pressure
- NAFLD fibrosis score, FIB-4 index, FLI
3) Change in the following items from baseline to 24 and 52 weeks
- Type IV collagen 7S domain, Ferritin, M2-BP, hs-CRP
4) Change in IL-6 from baseline to 52 weeks
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
Oral administration of 2.5 mg luseogliflozin once a day, pre or post breakfast for 52 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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Aged >=20, =<80 at consent
2) Poorly glycemic controlled patients who undergo diet/exercise therapy or treatment with hypoglycemic agents for at least 12 weeks
3) HbA1c >= 6.5 and < 9.5%
4) BMI >= 20 kg/m2
5) Provide written informed consent
6) With hepatic dysfunction (ALT>=31 IU/L)
Key exclusion criteria
1) Type 1 diabetes
2) Has history of severe ketosis, diabetic coma, or precoma
3) With severe infection, pre or post surgery, and serious trauma
4) With severe renal dysfunction (eGFR<30 mL/min/1.73m2)
5) Has stroke, myocardial infarction, or other serious cardiovascular complications requiring hospitalization within 6 months
6) Receiving SGLT2 inhibitor
7) Nursing or pregnant or planning to become pregnant
8) Has hypersensitivity to luseogliflozin or any other excipients of luseogliflozin
9) Considered as inadequate by the investigator
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroaki Seino |
Organization
Seino Internal Medicine Clinic
Division name
Medical director
Zip code
Address
6-192-2, Kaisei, Koriyama-city, Fukushima, Japan
TEL
024-983-1024
kn7jh5@bma.biglobe.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroaki Seino |
Organization
Seino Internal Medicine Clinic
Division name
Medical director
Zip code
Address
6-192-2, Kaisei, Koriyama-city, Fukushima, Japan
TEL
024-983-1024
Homepage URL
kn7jh5@bma.biglobe.ne.jp
Sponsor or person
Institute
Seino Internal Medicine 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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 23 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 12 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 23 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 23 | Day |
Last modified on
| 2018 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029679
| 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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