A 24 Week, Multicenter, Prospective, Open-labeled, Single-arm, Exploratory Phase 4 Clinical Trial to Evaluate the Safety and Efficacy of Lobeglitazone in Decreasing Intrahepatic Fat Contents in Type 2 Diabetes With NAFLD
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- changes from baseline in controlled attenuation parameters (CAP)
研究概览
简要总结
Lobeglitazone is highly selective peroxisome proliferator-activated receptor-gamma agonist that decreases insulin resistance in the periphery and liver resulting in increased insulin-dependent glucose disposal and decreased hepatic glucose output. In vivo, It demonstrates that Lobeglitazone improves even more glycemic and lipid control in comparison to rosiglitazone and pioglitazone. Currently, thiazolidinediones such as pioglitazone is the only drug which is considered as an effective therapeutic agent for improving non-alcoholic fatty liver disease (NALFD) in type 2 diabetes (T2D).
The aim of this multicenter, prospective, open-labeled, single-arm, exploratory phase 4 study is to evaluate the efficacy and safety of Lobeglitazone once daily for 24 weeks on intrahepatic fat contents assessed by transient elastography (fibroscan) in T2D with NAFLD.
Fifty subjects with T2D and NAFLD will take Lobeglitazone (0.5mg/tablet, orally, 1 tablet once daily) for 24 weeks.
Primary endpoint is changes from baseline in controlled attenuation parameters (CAP) measured by transient elastography (fibroscan) after treatment with Lobeglitazone.
Secondary endpoints are changes from baseline in glycemic profiles (HbA1c, Glycated albumin), Lipid parameters (Total Cholesterol, Triglycerides, HDL-C, LDL-C), Liver function parameters (AST, ALT, r-GT), and adverse events during the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type Ⅱ diabetes mellitus
- •Non-alcoholic fatty liver disease: subjects who have CAP(Controlled Attenuation Parameter) ≥ 250dB/m measured by transient elastography (fibroscan) at screening test
- •Age ≥ 20 years
- •Patients who have not been taking any oral hypoglycemic agent for more than 12 weeks with HbA1c 7.0 to 8.5% at screening test or who have been taking metformin monotherapy for at least 8 weeks with HbA1c 7 to 9% at screening test
- •Agreement with written informed consent
排除标准
- •Patients whose alcohol consumption >210g/week for males and 140g/week for females
- •chronic B viral hepatitis, chronic C viral hepatitis, Type I diabetes, or secondary diabetes
- •having a history of acute or chronic metabolic acidosis including diabetic ketoacidosis
- •patients who have been taking other oral hypoglycemic agents except metformin or insulin within recent 8 weeks
- •who experienced hypersensitivity reaction against metformin or glitazone drugs
- •who has been treated with corticosteroids for at least 14 days within 2 month prior to Screening
- •having a history of lactic acidosis
- •having genetic predispositions such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
- •who are in condition of malnutrition, starvation, cachexia, severe infection, major trauma, hypopituitarism, or adrenal insufficiency
- •diagnosed with cancer within 2 years or having chemo or radiotherapy for cancer treatment
- •a history of drug abuse or chronic alcoholism
- •a history of heart failure (NYHA class III and IV) or uncontrolled arrhythmia
- •a history of acute cardiovascular or cerebrovascular disease within 12 weeks prior to Screening (unstable angina, myocardial infarction, transient ischemic attack, cerebral infarct, cerebral hemorrhage, coronary bypass, percutaneous coronary intervention)
- •Renal dysfunction: Serum creatinine greater than 1.5mg/dl for males and 1.4mg/dl for females.
- •Anemia less than 10.5g/dl for any reason
- •Pregnant women or nursing mothers
- •Fertile women who not practice contraception with appropriate methods
- •in treatment concomitant drug from other clinical trials within 4 weeks from enrollment
- •who did not agree with written informed consent
研究组 & 干预措施
Lobeglitazone
干预措施: Oral administration of Lobeglitazone (Drug)
结局指标
主要结局
changes from baseline in controlled attenuation parameters (CAP)
时间窗: 24 weeks
Changes from baseline in controlled attenuation parameters (CAP) measured by transient elastography (fibroscan) after treatment with Lobeglitazone
次要结局
未报告次要终点