Efficacy of Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets on the Patients With Newly Diagnosed Type 2 Diabetes Mellitus Combined With Non-alcoholic Fatty Liver Disease：an Multicenter，Randomized, Double-blind, Parallel- Controlled Study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change of B-cell function after 24 weeks treatment as assessed by homeostasis model assessment of insulin resistance index
研究概览
简要总结
This is an multicenter, randomized, double-blind, parallel-controlled study to evaluated the efficacy of pioglitazone hydrochloride and metformin hydrochloride tablets on the patients with newly diagnosed type 2 diabetes mellitus combined with non-alcoholic fatty liver disease.
详细描述
Taking metformin monotherapy as a control, we evaluated the efficacy of pioglitazone hydrochloride and metformin hydrochloride tablets on hepatic fat ultrasound and liver enzyme levels, and observed whether the drug can improve fatty liver in patients with newly diagnosed type 2 diabetes combined with non-alcoholic fatty liver disease. This is an multicenter, randomized, double-blind, parallel-controlled study.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To meet the new diagnosed type 2 diabetes patients, never received oral hypoglycemic drugs or insulin therapy;
- •In accordance with the nonalcoholic fatty liver (NAFLD) criteria for the diagnosis of patients.
- •the level of HbA1c was 7 -10.0%;
- •age 18-70, body mass index 21-35kg/m2;
- •the subjects informed consent and signed the informed consent.
排除标准
- •type 1 diabetes or secondary diabetes;
- •suffering from other liver diseases, such as hepatitis, self - free liver, etc.
- •abnormal thyroid function (in the active period), or the need for long-term oral and intravenous glucocorticoids to treat patients;
- •patients with severe renal dysfunction or renal disease (eGFR<60);
- •in those with abnormal liver function, Alanine transaminase(ALT) or Aspartate transaminase(AST) was more than 3 times the normal upper limit.
- •people with serious gastrointestinal diseases such as peptic ulcers and chronic diarrhea;
- •patients with severe cardiopulmonary disease, cerebrovascular disease or stents;
- •hemopoietic system diseases such as serious primary diseases, hemoglobin < 100g/L or need regular transfusion treatment;
- •pregnant, breast-feeding, women of childbearing age who are unwilling to contraception during the study period;
- •chronic cardiac insufficiency, the classification of heart function III level and above;
- •uncontrolled malignant tumor, and the history of bladder cancer.
- •acute complications of diabetes;
- •the use of other drugs for diabetes and liver disease;
- •patients who had participated in other clinical studies within three months;
- •people who have known allergies to this kind of drugs are known.
- •it is impossible to guarantee the effect or the safety judgment of the drug or the person who is unable to cooperate with the mental illness.
研究组 & 干预措施
Combination of Pioglitazone and Metformin Tablets
dosage form: tablet; dosage:15mg/500mg; frequency: the dose in week 1 is 15mg/500mg, once a day, increased to 15mg/500mg in the second week, twice a day and maintain this dose to 24 weeks duration: 24 weeks; type: oral;
干预措施: Combination of Pioglitazone and Metformin Tablets (Drug)
Metformin Hydrochloride Tablets
dosage form: tablet; dosage: 850mg; frequency: the dose in week 1 is 850mg, once a day, increased to 850mg in the second week, twice a day and maintain this dose to 24 weeks duration: 24 weeks; type: oral;
干预措施: Metformin Hydrochloride Tablets (Drug)
结局指标
主要结局
Change of B-cell function after 24 weeks treatment as assessed by homeostasis model assessment of insulin resistance index
时间窗: up to 24 weeks
Change from baseline B-cell function to up to 24 weeks after treatment
Change of liver enzyme after 24 weeks treatment as assessed by blood test
时间窗: up to 24 weeks
Change from baseline liver enzyme to up to 24 weeks after treatment
Decreased of liver fat content of fatty liver after 24 weeks treatment as assessed by B-ultrasound
时间窗: up to 24 weeks
Change from baseline liver fat content to up to 24 weeks after treatment
次要结局
- Decreased of fasting blood glucose after 24 weeks treatment as assessed by blood test(up to 24 weeks)
- Change of weight and waistline after 24 weeks treatment as assessed by standard measurement(up to 24 weeks)
- Decreased of HbA1c after 24 weeks treatment as assessed by blood test(up to 24 weeks)