JPRN-jRCTs021180017已完成未知
Efficacy and safety of luseogliflozin in patient with type 2 diabetes complicated with hepatic dysfunction
Seino Hiroaki0 个研究点目标入组 55 人开始时间: 2019年3月25日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 55
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 80age old（—）
- 性别
- All
入选标准
- •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)
排除标准
- •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
研究者
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