JPRN-jRCTs031190040已完成未知
Effect of tofogliflozin on liver fat content compared to metformin in type 2 diabetes patients with nonalcoholic fatty liver disease
Yumi Takiyama0 个研究点目标入组 9 人开始时间: 2019年6月17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
- 9
研究概览
简要总结
SGLT2 inhibitors tended to reduce liver fat content and liver hardness compared to the control drug metformin, but the number of samples was small, individual differences were large, and statistically significant differences were not observed. Regarding safety, no serious adverse events were observed, and there was no need to change other therapeutic agents.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Type 2 diabetic patients who satisfy all the following criteria
- •1.Clinically diagnosed with NAFLD / NASH(within 3 years before informed consent)
- •2.6.5% < HbA1c < 10.0%
- •3.8 % < MRI-PDFF(within 12 weeks before informed consent)
- •4.Patients who can take metformin and tofogliflozin
- •5.20 years < age
- •6.Written informed consent
排除标准
- •1.Type 1 diabetes or gestational diabetes
- •2.Use of SGLT2 inhibitor within 12 weeks before informed consent
- •3.Use of biguanide within 12 weeks before informed consent
- •4.Use of GLP-1 receptor agonist within 12 weeks before informed consent
- •5.Use of Thiazolidine within 12 weeks before informed consent
- •6.Use of Vitamin E preparation within 12 weeks before informed consent
- •7.Contraindication to tofogliflozin and metformin
- •8.Hypersensitivity to tofogliflozin and metformin
- •9.Absolute indications for insulin treatment
- •10.History of hypoglycemia with loss of consciousness
- •11.eGFR < 30mL/min/1.73m2
- •12.Serious liver functional impairment(Child-Pugh classification B or C)
- •13.History of cancer or high possibility of cancer recurrence
- •14.Pregnant, or possibly pregnant, nursing
- •15.Other ineligibility determined by an investigator
研究者
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