NCT03039075已完成4 期
Comparison of Metformin Hydrochloride Sustained-release Tablet (DuLeNing) and Glucophage in Patients With Type 2 Diabetes
Chongqing Medical University1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2016年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Changes of HbA1c
研究概览
简要总结
Metformin hydrochloride sustained-release tablets made in Conquer pharmaceutical co., LTD is approved by China Food And Drug Administration (cFDA). Whether its efficacy and safety are equal to Glucophage is unclear.
详细描述
To perform a RCT for the comparison between Metformin hydrochloride sustained-release tablets made in Conquer pharmaceutical co., LTD and Glucophage .
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Well informed of the procedures of this trial and informed consent is obtained
- •Voluntarily accept standardized treatment 3.18-75 years old, gender is not limited
- •4.Newly diagnosed as type 2 diabetes and have not yet received any hypoglycemic therapy 5.Unable to control the blood glucose by diet and exercise: 7.5% ≤HbA1c ≤11.0%, in screening and before randomization 6.BMI: 19~35 kg/m2 7.Well compliance 8.Capable of self blood Glucose monitoring
排除标准
- •Pregnant or lactating
- •Type 1 diabetes
- •Poor blood glucose control（HbA1c>11%）
- •A history of malignant tumor
- •Abnormal liver or renal function (defined as alanine aminotransferase(ALT)>2.5 times higher than normal range,or eGFR<45 mL/min per 1•73 m²)
- •Poor blood pressure control [systolic blood pressure(SBP)>180mmHg,or diastolic blood pressure(DBP)>110mmHg]
- •With severe heart disease,cardiac function worse than grade II,anemia(Hb<9.0g/d1)
- •Continuous use of antidiabetic drugs more than one week in recent 3 months
- •History of acute metabolic complications in recent 6 months
- •Blood routine test indicates that the white blood cell count(WBC) <3*109/l
- •Body Mass Index(BMI)<18.5 or ≥35kg/m2
- •Drug or alcohol abuse
- •Accompanying mental disorder who can't collaborate
- •Abnormal digestion and absorption function
- •Other endocrine diseases
- •Other chronic diseases needed long-term glucocorticoid treatment
- •With severe infection, immune dysfunction
- •A history of metformin allergies or allergic constitution
研究组 & 干预措施
Metformin SR Tablet
Active Comparator
Metformin hydrochloride sustained-release tablets made in Conquer pharmaceutical co., LTD
干预措施: Metformin SR Tablet (Drug)
Glucophage
Active Comparator
The original drug of metformin
干预措施: Metformin SR Tablet (Drug)
结局指标
主要结局
Changes of HbA1c
时间窗: 12 weeks
Efficacy
次要结局
- Changes of intestinal flora proportion(12 weeks)
- Changes of weight(12 weeks)
- Changes of LDL, HDL, TG, TC(12 weeks)
- Incidence of nausea, diarrhea(12 weeks)
研究者
Qifu Li
Primary Investigator
Chongqing Medical University
研究点 (1)
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