UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027337 |
|---|---|
| Receipt number | R000031322 |
| Scientific Title | Open prospective randomized controlled study on the effects of SGLT2 inhibitor and bezafibrate on blood glucose control and NAFLD (nonalcoholic fatty liver disease)/START study |
| Date of disclosure of the study information | 2017/05/14 |
| Last modified on | 2017/11/14 09:48:29 |
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Basic information
Public title
Open prospective randomized controlled study on the effects of SGLT2 inhibitor and bezafibrate on blood glucose control and NAFLD (nonalcoholic fatty liver disease)/START study
Acronym
Open prospective randomized controlled study on the effects of SGLT2 inhibitor and bezafibrate on blood glucose control and NAFLD (nonalcoholic fatty liver disease)/START study
Scientific Title
Open prospective randomized controlled study on the effects of SGLT2 inhibitor and bezafibrate on blood glucose control and NAFLD (nonalcoholic fatty liver disease)/START study
Scientific Title:Acronym
Open prospective randomized controlled study on the effects of SGLT2 inhibitor and bezafibrate on blood glucose control and NAFLD (nonalcoholic fatty liver disease)/START study
Region
| Japan |
Condition
Condition
Type 2 diabetes with nonalcoholic fatty liver disease
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of therapeutic effect on NAFLD using SGLT2 inhibitor, bezafibrate or conventional therapeutic agent
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change from baseline in liver-to-spleen attenuation ratio (L/S ratio) by CT at week 60
Key secondary outcomes
Changes from baseline in AST, ALT, HbA1c, fasting plasma glucose, bodyweight, abdominal visceral adipose tissue, and subcutaneous adipose tissue, Hypoglycemia by using CGM, electrocardiogram change by using Holter electrocardiogram
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
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
SGLT2 inhibitor for 60 weeks
Interventions/Control_2
Bezafibrate 200~400mg for 60 weeks
Interventions/Control_3
SGLT2 inhibitor/Bezafibrate 200-400mg combined group for 60 weeks
Interventions/Control_4
Conventional treatment group for 60 weeks
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 with type 2 diabetes
2. Patients(20 years or over and under 70 years old ) who are able to provide written informed consent.
3.HbA1c higher than 6.0 and lower than 10%
Key exclusion criteria
1.type 1 diabetic patients
2.patients who are being treated for liver disease other than NAFLD
3.Male:serum creatinine higher than 1.2mg/dL Femake:serum creatinine higher than 1.0mg/dL patients
4.Patients who can not be aware of dry mouth
5.SGLT2 inhibitor/Bezafibrate contraindication case
6.Patients with a history of hypersensitivity to SGLT2 inhibitor/Bezafibrate
7.Patients judged to be ineligible by a doctor
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ikuo Inoue |
Organization
Saitama Medical University Hospital
Division name
Department of Endocrinology and Diabetes
Zip code
Address
38 Morohongo, Moroyamacho, Irumagun, Saitama 350-0495, Japan
TEL
049-276-1204
i1901018@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daigo Saito |
Organization
Saitama Medical University Hospital
Division name
Department of Endocrinology and Diabetes
Zip code
Address
38 Morohongo, Moroyamacho, Irumagun, Saitama 350-0495, Japan
TEL
049-276-1204
Homepage URL
daigo622@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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 | 05 | Month | 14 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 05 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | 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 | 05 | Month | 14 | Day |
Last modified on
| 2017 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031322
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
