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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027337
Receipt No. 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

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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
Email 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
Email daigo622@saitama-med.ac.jp

Sponsor
Institute Saitama Medical University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031322

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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