Effect of tofogliflozin and pioglitazone on hepatic steatosis in non-alcoholic fatty liver disease (NAFLD) patients with type 2 diabetes. Randomized, open label pilot study. - Effect of tofogliflozin and pioglitazone on hepatic steatosis in NAFLD patients with type 2 diabetes.

Yokohama City University0 个研究点目标入组 40 人开始时间: 2017年12月15日最近更新: 2023年10月17日

适应症

试验速览

阶段: 未知
状态: 已完成
发起方: Yokohama City University
入组人数: 40

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

Both tofogliflozin and pioglitazone improved the primary endpoint (absolute change in MRI-PDFF), the primary secondary endpoint (absolute change in ALT), and glucose metabolism after 24 weeks of monotherapy. It was also suggested that the combination of both drugs may further improve HbA1c and hepatic lipids, and that tofogliflozin may reduce the weight gain side effect of pioglitazone by combination therapy.

研究设计

研究类型: Interventional

入排标准

年龄范围: 20years-old 至 75years-old（—）
性别: All

入选标准

未提供

排除标准

•1. Alcohol consumption greater than 30g/day ethanol for males or 20g/day ethanol for females. 2. Patients diagnosed viral hepatitis. 3. Other causes of liver disease including autoimmune and drug -induced hepatic injury. 4. Patients diagnosed hepatic cirrhosis or serious hepatic dysfunction (Child-Pugh B and C). 5. Platelet count < 150,000/mm3 (measured within 90 days before study registration). 6. BMI < 22 kg/m2 (measured within 90 days before study registration). 7. ALT >= 5 times higher than the upper limited normal (measured within 90 days before study registration) 8. Serious renal dysfunction or eGFR < 60 mL /min/1.73 m2 (measured within 90 days before study registration). 9. Type 1 diabetes or HbA1c >= 9.0% (measured within 90 days before study registration) 10. Patients using SGLT2 inhibitors, pioglitazone, insulin or GLP-1 agonists. 11. Patients taking vitamin E. 12. Contraindications to the MRI (for example, patients using heart pacemaker). 13. Patients who can not undergo MRI (for example, patients who can not hold breath long enough or patients with iron overload). 14. Heart failure (NYHA III or more) 15. Patients with cancer or history of cancer in previous 5 years. 16. Severe ketosis, diabetic coma or precoma. 17. Sever infection, within one week before or after the surgery, sever injury. 18. History of hypersensitivity to any of the ingredients of the study drug. 19. Pregnant women, women suspected of being pregnant. 20. Lactating women or patients who can not prevent conception during study period. 21. Patients who are ineligible in the opinion of the investigator.

研究者

发起方

Yokohama City University

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