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The effectiveness of oral hypoglycemic agents in nonalcoholic fatty liver disease patients with type 2 diabetes mellitus. -Multiple comparison, Dapagliflozin, Pioglitazone vs Glimepiride-

The effectiveness of oral hypoglycemic agents in nonalcoholic fatty liver disease patients with type 2 diabetes mellitus. -Multiple comparison, Dapagliflozin, Pioglitazone vs Glimepiride- - The effectiveness of oral hypoglycemic agents in nonalcoholic fatty liver disease patients with type 2 diabetes mellitus. -Multiple comparison, Dapagliflozin, Pioglitazone vs Glimepiride-

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000021291
Enrollment
90
Registered
2016-03-02
Start date
2015-10-19
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

Nonalcoholic fatty liver disease patients with type 2 diabetes

Interventions

Dapagliflozin 5mg Sig. 1 or 2 tab po once time a day Pioglitazone 15mg Sig. 1 or 2 tab po once time a day Glimepiride 0.5 or 1mg Sig. 1 or 3 tab po once or two times a day

Sponsors

Kawasaki Medical SchoolKawasaki Medical School Devision of Diabetes, Endocrinology and Metabolism
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Nonalcoholic fatty liver disease patients with type 2 diabetes mellitus who visit a hospital for treatment in the outpatient department of the facilities concerned.

Exclusion criteria

Exclusion criteria: A) Under 20 years old B) Treatment with insulin C) Treatment with SGLT-2 inhibitor, thiazolidinedione or sulfonylurea D) Diabetic coma E) Renal dysfunction (eGFR<45mL/min) F) Cardiac failure G) Viral hepatitis, alcoholic hepatitis, autoimmune hepatitis, liver cirrhosis H) Infection I) During treatment or treatment plan of malignant neoplasm J) Autoimmune disease K) Use of Steroid medicine and/or immunosuppressor L) Pregnant, possibility of pregnancy, nursing or hope to become pregnant during the study period M) In addition, when principal investigator or researcher deems inappropriate as a study subject

Design outcomes

Primary

MeasureTime frame
Change of liver function and L/S ratio (CT) six months after the intervention

Secondary

MeasureTime frame
Change of body weight, visceral fat amount, fasting plasma glucose (FPG), insulin, triacylglycerol (TG), non-esterified fatty acid (NEFA), HDL-cholesterol, LDL-cholesterol, lipoprotein fractionation, adiponectin, hsCPR, TNF-alpha, MCP-, MDA, typIV collagen7S, P-III-P, M2BP, the fibrosis score (NAFLD fibrosis score, FIB-4 index, APRI, BARD score, BAAT score), proinsulin/S-CPR ratio

Countries

Japan

Contacts

Public ContactMasashi Shimoda

Kawasaki Medical SchoolKawasaki Medical School Devision of Diabetes, Endocrinology and Metabolism

masashi-s@med.kawasaki-m.ac.jp086-462-1111

Outcome results

None listed

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