Efficacy and safety of luseogliflozin in patient with type 2 diabetes complicated with hepatic dysfunctio

Not Applicable

• Conditions: Type 2 Diabetes Mellitus; Diabetes Mellitus, Type 2; D003924

• Registration Number: JPRN-jRCTs021180017
• Lead Sponsor: Seino Hiroaki

Brief Summary

AST, ALT, and gamma-GTP were all significantly improved from baseline to week 52. Also, HbA1c, fasting plasma glucose, insulin resistance, body weight, BMI, and abdominal circumstance were improved. No noteworth adverse event or disease or the like were reported. These suggest that luseoglifrozin is safe and effective in type 2 diabetes mellitus patients with hepatic dysfunction, improving hepatic function, glycemic contorol, and other clinical outcomes.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-25
• Study Completion: 2019-09-07
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

1) Aged >=20, =<80 at consent
2) Poorly glycemic controlled patients who undergo diet/exercise therapy or treatment with hypoglycemic agents for at least 12 weeks
3) HbA1c >= 6.5 and < 9.5%
4) BMI >= 20 kg/m2
5) Provide written informed consent
6) With hepatic dysfunction (ALT>=31 IU/L)

Exclusion Criteria

1) Type 1 diabetes
2) Has history of severe ketosis, diabetic coma, or precoma
3) With severe infection, pre or post surgery, and serious trauma
4) With severe renal dysfunction (eGFR<30 mL/min/1.73m2)
5) Has stroke, myocardial infarction, or other serious cardiovascular complications requiring hospitalization within 6 months
6) Receiving SGLT2 inhibitor
7) Nursing or pregnant or planning to become pregnant
8) Has hypersensitivity to luseogliflozin or any other excipients of luseogliflozin
9) Considered as inadequate by the investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change and percent change in AST, ALT, gamma-GTP, and HbA1c from baseline to 52 weeks

Secondary Outcome Measures

Name	Time	Method
1) Change in the following items from baseline to 12 and 24 weeks <br>- AST, ALT, gamma-GTP, HbA1c <br>2) Change in the following items from baseline to 12, 24, and 52 weeks <br>- Fasting plasma glucose, HOMA-beta, HOMA-IR <br>- Body weight, BMI, Waist circumference, and Blood pressure <br>- NAFLD fibrosis score, FIB-4 index, FLI <br>3) Change in the following items from baseline to 24 and 52 weeks <br>- Type IV collagen 7S domain, Ferritin, M2-BP, hs-CRP <br>4) Change in IL-6 from baseline to 52 weeks