To Evaluate the Effect of Nesinaact on Non-alcoholic Steatohepatitis Through MRI and Liver Fibroscan in Patients With Type 2 Diabetes: A Prospective, Open-Label, Single-Arm, Single-Center Clinical Study
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- A degree of liver steatosis
研究概览
简要总结
This study was designed to evaluate the effect of Nesinaact on non-alcoholic steatohepatitis through magnetic resonance imaging (MRI)-based proton density-fat fraction (MRI-PDFF) and liver fibroscan in patients with type 2 diabetes. This is a prospective, open-label, single-arm, single-center clinical Study. After 24 weeks of Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment, the improvement of parameters estimated by MRI and liver fibroscan will be estimated.
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
盲法说明
No masking is applied, as this is an open label study
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
- •Male or female patients ages >= 20 years
- •Patients diagnosed with non-alcoholic fatty liver disease (NAFLD).
- •=> Definition of NAFLD: CAP (Controlled attenuation parameter) >= 250 dB/m
- •Diabetic patients who meet one of the following glycemic conditions:
- •Patients with glycated hemoglobin (HbA1c) ranging 6.5~8.5 % while not taking an antidiabetic for more than 12 weeks irrespective of duration of diabetes.
- •Patients with HbA1c ranging 6.5~9.0 % in screening while using metformin monotherapy for more than 8 weeks without changing the dose irrespective of duration of diabetes.
排除标准
- •Patients who meet the criteria for alcoholic liver disease whose alcohol intake for the recent tow years if above 210 g per week in men and above 140 g per week in women)
- •Patients with chronic hepatitis B, C, or type 1 diabetes, or secondary diabetes
- •Patients with history of acute or chronic metabolic acidosis and ketoacidosis, including diabetic ketoacidosis accompanied or not accompanied by coma
- •Patients who were administered an oral hypoglycemic agent or insulin other than metformin within 8 weeks prior ro screening, or are likely to be administered it during the study duration among patients receiving monotherapy.
- •Patients who had hypersensitivity to biguanide or glitazone in the past.
- •Patients who received oral or parenteral corticosteroid treatment chronically (for more than 14 consecutive days) within 8 weeks prior to screening
- •Patients wih past history of lactic acidosis
- •Patients with a genetic disorder, such as galactose intolerance, Lapp lactase deficiency or glucose-galactose impaired absorption, etc.
- •Patients wih malnutrition, starvation, weakness, (Including patients with severe infection), pituitary insufficiency or adrenal insufficiency
- •Patients who have been receiving radiotherapy or chemotherapy due to bladder cancer and other malignant tumor, or it is less than 2 years since the patients received it.
- •Patients with past history of bladder cancer
- •A patient with history of drug abuse or alcoholism in 12 weeks
- •A patient who has hear failure (NYHA class 3~4) or uncontrolled arrhythmia within 6 months
- •A patient who has acute cardiovascular disease within 12 weeks (including unstable angina, myocardial infarction, transient ischemic attack, cerebrovascular disease, coronary artery bypass, or coronary intervention)
- •A person who falls under one of the followings:
- •A patient with serum creatinine level >= 1.5 mg/dL in men and 1.4 mg/dL in women or a patient wih moderate to severe renal impairment (creatinine clearance: < 50 ml/min) 2) An anemia patient with 10.5 g/dL of Hb level
- •A pregnant or nursing woman
- •A patient who does not consent to use a proper method of contraception during the study period only among women or men of childbearing age
- •A patient who has taken investigational drug in other clinical study within 4 weeks following informed consent
- •A person who may not participate in the study according to investigator's judgement
- •A person who cannot read the informed consent form (e.g: an illiterate, a foreigner, etc.)
研究组 & 干预措施
1
Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment for 24 weeks
干预措施: Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment for 24 weeks (Drug)
结局指标
主要结局
A degree of liver steatosis
时间窗: 24 weeks after starting Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment
Magnetic resonance imaging (MRI)-based proton density-fat fraction (MRI-PDFF) will be evaluated to confirm the improvement in liver steatosis.
A degree of liver fibrosis
时间窗: 24 weeks after starting Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment
In liver fibroscan, liver stiffness (kPa) as a marker of fibrosis and CAP (dB/m) as a marker of steatosis will be estimated.
次要结局
- Clinical glucometabolic parameters : HbA1c(24 weeks after starting Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment)
- Clinical glucometabolic parameters :Anthropometric parameters(24 weeks after starting Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment)
- Clinical glucometabolic parameters : Lipid parameters(24 weeks after starting Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment)
- Clinical glucometabolic parameters : Liver enzymes(24 weeks after starting Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment)