A Randomized, Active-comparator Controlled, Parallel-group Study, to Evaluate the Effect of Empagliflozin and Dulaglutide on MAFLD in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 135
- 主要终点
- Changes of HbA1c level
研究概览
简要总结
The co-administration of SGLT2 inhibitor and GLP-1 receptor agonist would be safe and effective on glycemic control in subjects with type 2 diabetes mellitus and MAFLD better than empagliflozin or dulaglutide alone.
The SGLT2 inhibitor and GLP-1 receptor agonist would be safe and effective on fatty liver disease in subjects with type 2 diabetes mellitus and MAFLD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 20 or over
- •uncontrolled HbA1c (7~10%) with metformin and/or sulfonylurea
- •Hepatic steatosis estimated by Fibroscan (CAP ≥258 dB/m)
- •MAFLD: presence of any conditions
- •Overweight or obese: BMI ≥23 kg/m2 (Asian)
- •Metabolic dysregulation: at least of two of following criteria
- •Waist circumference: ≥90/80 cm in men and women (Asian)
- •Blood pressure ≥130/85 mmHg or drug treatment
- •Plasma triglycerides ≥150 mg/dL or drug treatment
- •Plasma HDL-cholesterol <40/50 mg/dL for men and women or drug treatment
- •Prediabetes (i.e. fasting glucose levels 100 to 125 mg/dL or 2-hour post-load glucose levels 140 to 199 mg/dL or HbA1c 5.7% to 6.4%
- •HOMA-insulin resistance score ≥2.5
- •Plasma high-sensitivity CRP >2 mg/L
排除标准
- •Significant alcohol consumption
- •Other competing causes for hepatic steatosis: viral hepatitis, drug-induced hepatitis, autoimmune hepatitis, hemochromatosis, Wilson's disease, alpha1 anti-trypsin deficiency, Celiac disease, Overt hypothyroidism, other secondary causes
- •Type 1 diabetes mellitus
- •medication usage within 3 months: vitamin E, PUFA, UDCA, fish oil, SGLT2 inhibitors, GLP1-RAs, TZDs
- •Severe organ dysfunction
- •liver damage: AST/ALT >x5 UNL, albumin <3.2, platelet <60k, Child-Pugh-Turcotte stage B or C
- •kidney damage: serum creatinine ≥2.0 mg/dL or eGFR <50 mL/min/1.72m2
- •Hepatocellular carcinoma, active tumor, or metastasis
- •End-stage liver disease
研究组 & 干预措施
Empagliflozin
Empagliflozin 10mg p.o. once daily (available to control over ~25mg)
干预措施: Empagliflozin (Drug)
Dulaglutide
Dulaglutide 0.75mg s.c. once weekly (available to control over ~1.5mg)
干预措施: Dulaglutide (Drug)
Empagliflozin and Dulagludie
Empagliflozin 10mg p.o. once daily and dulaglutide 0.75mg s.c. once weekly
干预措施: Empagliflozin and Dulaglutide (Drug)
结局指标
主要结局
Changes of HbA1c level
时间窗: baseline, week 12, week 24
Patients achieving the target level
Changes of CAP score
时间窗: baseline, week 24
Controlled Attenuation Parameter (CAP) score by transient elastography
次要结局
- Changes of LSM score(baseline, week 24)
- Changes of body weight and body composition(baseline, week 24)
- Changes of lipid levels(baseline, week 12, week 24)
- Changes of ketone levels(baseline, week 12, week 24)
- Changes of liver parenchyma by ultrasonography(baseline, week 24)
- Changes of noninvasive liver fibrosis markers(baseline, week 12, week 24)
- Changes of liver function parameters(baseline, week 12, week 24)
- Changes of liver fibrosis biomarkers(baseline, week 24)
- Changes of inflammation biomarker(baseline, week 24)
研究者
Soo Lim
Professor
Seoul National University Bundang Hospital