Efficacy of Liraglutide vs. Sitagliptin vs. Insulin Glargine Per Day on Liver Fat When Combined With Metformin in T2DM Subjects With Non-alcoholic Fatty-liver Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Intrahepatic lipids (IHL)
研究概览
简要总结
The aim of this study is to explore the effectiveness of liraglutide combined with metformin in non-alcoholic fatty-liver disease patients with type 2 diabetes mellitus (T2DM) compared to sitagliptin and insulin glargine in combination with metformin.
详细描述
This is a 26-week, randomized, open-label, active controlled, parallel group, multi-centre trial.To compare the change of intrahepatic lipids (IHL) as measured by magnetic resonance spectroscopy(MRS) or MRI estimated proton density fat fraction (MRI-PDFF) as measured by MRI IDEAL IQ (Iterative Decomposition of water andfat with Echo Asymmetryand Least-squares estimation) in type 2 diabetic patients with non-alcoholic fatty-liver disease after a 26-week treatment of liraglutide, sitagliptin or insulin glargine per day combined with metformin.The primary endpoint will be defined by intrahepatic lipids (IHL) as measured by magnetic resonance spectroscopy (MRS) or MRI-PDFF as measured by MRI IDEAL IQ.
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
- None
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recorded Type 2 diabetes diagnosed at least 3 months before the study; At least 3 months treatment on a stable dose（≧1500mg/d）of metformin before the study
- •6.5%<HbA1c ≤10%
- •Clinically diagnosed simple liver steatosis
- •30-75 years old
- •Female subjects should be postmenopausal, surgically sterile, or using contraceptives for 3 months before screening and continuing throughout the study;
- •BMI 20~35 kg/m2 and with a history of stable body weight (≤10%variation for ≥3 months)
- •intrahepatic lipids (IHL) >10%
排除标准
- •Type 1 diabetes
- •Treatment within the last 3 months with Thiazolidinediones(TZDs), orlistat, insulin, any history of incretin based therapy or any other drugs associated with hepatic steatosis (including but not limited to glucocorticoids, tamoxifen, amiodarone or methotrexate)
- •History or current episode of pancreatitis or other disease of the pancrea; Impaired liver function, defined as plasma alanine transaminase(ALT) >2.5 times of upper normal limit
- •Moderate and severe renal insufficiency defined as MDRD formula glomerular filtration rate<60ml/min/1.73m2
- •Weekly alcohol intake>14 units for women or >21 units for men
- •Any history of liver disease including metabolic or auto-immune liver diseases or viral hepatitis
- •History or family history of medullary thyroid cancer(MTC), or multiple endocrine neoplasia type 2(MEN-2)
- •Congestive heart failure(NYHA III~IV)
- •Severe gastric-intestinal diseases
- •Pregnancy and/or intention of becoming pregnant
- •Known proliferative retinopathy or maculopathy requiring acute treatment as judged by the Investigator; Use of non-herbal Chinese medicine or other non-herbal local medicine with unknown/unspecified content. Herbal traditional Chinese medicine or other local herbal medicines may, at the Investigator's discretion, be continued throughout the trial at an unchanged dose
研究组 & 干预措施
Liraglutide
Liraglutide combined with metformin
干预措施: Liraglutide combined with metformin (Drug)
Insulin glargine
Insulin glargine combined with metformin
干预措施: Insulin glargine combined with metformin (Drug)
Sitagliptin
Sitagliptin combined with metformin
干预措施: Sitagliptin combined with metformin (Drug)
结局指标
主要结局
Intrahepatic lipids (IHL)
时间窗: 26-week
To compare the change of intrahepatic lipids (IHL) in type 2 diabetic patients with non-alcoholic fatty-liver disease after a 26-week treatment of liraglutide, sitagliptin or insulin glargine per day combined with metformin.
次要结局
- Change of abdominal subcutaneous adipose tissue(SAT)(26 weeks)
- Change of visceral adipose tissue(VAT)(26 weeks)
- Change in hemoglobin A1c(HbA1c)(26 weeks)
研究者
Jianping Weng
professor, vice president, the third affiliated hospital of Sun Yat-sen University
Sun Yat-sen University