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

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 - 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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000027337

Enrollment

Registered

2017-05-14

Start date

2017-06-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes with nonalcoholic fatty liver disease

Interventions

SGLT2 inhibitor for 60 weeks Bezafibrate 200~400mg for 60 weeks SGLT2 inhibitor/Bezafibrate 200-400mg combined group for 60 weeks Conventional treatment group for 60 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

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%

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Change from baseline in liver-to-spleen attenuation ratio (L/S ratio) by CT at week 60	—

Secondary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactDaigo Saito

Saitama Medical University Hospital Department of Endocrinology and Diabetes

daigo622@saitama-med.ac.jp049-276-1204

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026