UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045003 |
|---|---|
| Receipt number | R000050859 |
| Scientific Title | Additional effect of luseogliflozin on semaglutide for non-alcoholic steatohepatitis patients with type 2 diabetes |
| Date of disclosure of the study information | 2021/07/29 |
| Last modified on | 2024/07/28 11:20:26 |
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Basic information
Public title
Additional effect of luseogliflozin on semaglutide for non-alcoholic steatohepatitis patients with type 2 diabetes
Acronym
Alight Study
Scientific Title
Additional effect of luseogliflozin on semaglutide for non-alcoholic steatohepatitis patients with type 2 diabetes
Scientific Title:Acronym
Alight Study
Region
| Japan |
Condition
Condition
non-alcoholic steatohepatitis
type 2 diabetes
Classification by specialty
| Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of semaglutide and luseogliflozin combination therapy for NASH in patients with NASH complicated by type 2 diabetes mellitus, in contrast to those using semaglutide monotherapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Resolution of NASH without worsening of liver fibrosis after 52 weeks
2. Improvement of at least one point in NAFLD activity score without worsening of liver fibrosis after 52 weeks
3. Improvement of at least one fibrosis stage without worsening of NASH after 52 weeks
Key secondary outcomes
1. Proportion of cases with progression of liver fibrosis after 52 weeks
2. Change from baseline in liver stiffness according to FibroScan after 52 weeks
3. Change from baseline in steatosis according to FibroScan after 52 weeks
4. Change from baseline in weight, BMI, and body composition after 52 weeks
5. Change from baseline in HbA1c after 52 weeks
6. Change from baseline in liver enzymes after 52 weeks
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intervention group
After obtaining a written consent and completing baseline examination, semaglutide (0.25 mg) will be injected subcutaneously once a week. After 2 weeks of semaglutide treatment, luseogliflozin (2.5 mg) will be added once daily before or after breakfast. After 4 weeks of the initial semaglutide treatment, the dose of semaglutide (0.25 mg) will be increased to 0.5 mg. Semaglutide will be remained once a week. Medication will be continued until 52 weeks.
Interventions/Control_2
Control group
After obtaining a written consent and completing baseline examination, semaglutide (0.25 mg) will be injected subcutaneously once a week. After 4 weeks of semaglutide treatment, the dose of semaglutide (0.25 mg) will be increased to 0.5 mg. Semaglutide will be remained once a week. Medication will be continued until 52 weeks.
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients aged 20 to 75 years at the time of consent
2. Patients with type 2 diabetes who were diagnosed with NASH with stage 1 or more and NAS 4 or more according to the classification of the NASH Clinical Research Network (NASH CRN) by liver
biopsy within 6 months (180 days) before pre-examination or consent acquisition
3. Patients with HbA1c 6.5% or more (HbA1c 6% or more for those undergoing drug treatment) and 10.5% or less in the preliminary examination
4. Patients who provided written consent to participate in this study
Key exclusion criteria
1. Patients who received SGLT2 inhibitors or GLP-1 receptor agonists within 3 months prior to the start of the drug administration study or after liver biopsy
2. Patients who used other SGLT2 inhibitors or GLP-1 receptor agonists during the study period
3. Patients with a history of serious adverse reactions to SGLT2 inhibitors or GLP-1 receptor agonists
4. Patients with uncompensated liver cirrhosis
5. Patients with serious renal disease
6. Patients with malignant tumor
7. Patients with a history of severe hypoglycemia
8. Patients with a history of ketoacidosis
9. Patients with a history of cerebral infarction with paralysis
10. Patients with urinary tract/genital infections or repeated urinary tract/genital infections
11. Patients with hepatitis due to other causes
12. Patients who were hospitalized for acute coronary syndrome, unstable angina, acute myocardial infarction, acute cerebral infarction, or transient ischemic attack within 3 months prior to obtaining consent
13. Pregnant or lactating women
14. Patients who had started or changed the dose of pioglitazone or vitamin E within 6 months prior to starting the study drug, or within 3 months prior to liver biopsy until starting the study drug
15. Patients who regularly use oral steroids or injectable steroids
16. Patients who are participating in other clinical studies using the study drug while participating in this study
17. If, in the opinion of the Principal Investigator, or others, participation in the research is not in the best interest of the research subject, or if it is judged to interfere with, limit, or confuse the specific evaluation of the clinical research protocol
18. A person under the direction of the Principal Investigator or the medical institution conducting the research, an employee of the Principal Investigator or of the medical institution directly involved in this or other clinical research, or family members of such employees or the Principal Investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yoichi |
| Middle name | Teruki |
| Last name | Hiasa |
Organization
Ehime University Hospital
Division name
Internal Medicine 3
Zip code
7910295
Address
454 Shitsukawa Toon Ehime
TEL
089-960-5308
teruki-ygc@umin.ac.jp
Public contact
Name of contact person
| 1st name | Teruki |
| Middle name | |
| Last name | Miyake |
Organization
Ehime University Hospital
Division name
Internal Medicine 3
Zip code
7910295
Address
454 Shitsukawa Toon Ehime
TEL
089-960-5308
Homepage URL
miyake.teruki.mg@ehime-u.ac.jp
Sponsor or person
Institute
Ehime University
Institute
Department
Personal name
Funding Source
Organization
Taisho Pharmaceutical Holdings
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
Certified Review Board, Ehime University
Address
454 Shitsukawa, Toon , Ehime
Tel
089-960-5172
rinri@m.ehime-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
CRB6200002
Org. issuing International ID_1
Japan Registry of Clinical trial
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
愛媛大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 07 | Month | 29 | 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
60
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 05 | Month | 07 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 07 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 03 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 07 | Month | 29 | Day |
Last modified on
| 2024 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050859
