JPRN-jRCTs031180159已完成未知
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. - ToPiND study
Yoneda Masato0 个研究点目标入组 40 人开始时间: 2019年2月26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
- 40
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
- >= 20age old 至 <= 74age old（—）
- 性别
- All
入选标准
- •<1>Inclusion criteria for study entry;
- •1. men and women, aged 20-74 years.
- •2. Type 2 diabetic patients who have been treated with diet/exercise therapy.
- •3. HbA1c higher than 6.5% (measured within 90 days before study registration).
- •4. Clinically diagnosed NAFLD
- •5. ALT higher than the upper limited normal (measured within 90 days before study registration).
- •6. Patients who provide written consent to participate in the trial of their own free will.
- •<2>Inclusion criteria for randomization;
- •Patients with screening MRI-PDFF >= 10% steatosis.
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
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