Nanjing Medical University, Nanjing First Hospital
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Concentration of FBG, PBG and HbA1c
研究概览
简要总结
The aim of the study is to investigate the efficacy and safety of Mulberry Twig (Ramulus Mori, Sangzhi) Alkaloid Tablet and Canagliflozin for 12 weeks in individuals with type 2 diabetes mellitus
详细描述
To compare the clinical efficacy, insulin resistance and blood glucose fluctuation of Mulberry Twig (Ramulus Mori, Sangzhi) Alkaloid Tablet and Canagliflozin in patients with type 2 diabetes mellitus using FGMS.
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
- Single (Participant)
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
- •Volunteer to participate and be able to sign informed consent prior to the trial.
- •Patients with type 2 diabetes, aged 18-75 years old and BMI ≥18.0kg/m
- •Treatment with one or two hypoglycemic drugs (in combination, the sulfonylureas dose should be less than half of the maximum dose).
- •HbA1c : 7.0-9.0%.
- •Subjects are able and willing to monitor peripheral blood sugar and regularity of diet and exercise.
排除标准
- •Impaired liver and kidney function with ALT 2.5 times higher than the upper limit of normal value; Serum creatinine was 1.3 times higher than the upper limit of normal.
- •Recurrent urinary tract infections.
- •Drug abuse and alcohol dependence in the past 5 years.
- •Patients with poor compliance and irregular diet and exercise.
- •Systemic hormone therapy was used in the last three months.
- •Patients with infection and stress within four weeks.
- •Patients with pregnancy, lactation or pregnancy intention.
- •Any other obvious conditions or associated diseases determined by the researcher: such as severe cardiopulmonary diseases, endocrine diseases, neurological diseases, tumors and other diseases, other pancreatic diseases, history of mental diseases.
研究组 & 干预措施
Mulberry Twig Alkaloid Tablet
Mulberry Twig (Ramulus Mori, Sangzhi) Alkaloid Tablet
干预措施: Mulberry Twig Alkaloid Tablet (Drug)
Canagliflozin
Canagliflozin
干预措施: Canagliflozin (Drug)
结局指标
主要结局
Concentration of FBG, PBG and HbA1c
时间窗: 12 weeks
The effects of Mulberry Twig Alkaloid Tablet and Canagliflozin on the concentration of FBG, PBG and HbA1c in patients with type 2 diabetes mellitus.
Concentration of MBG, TIR, TAR, TBR, MAGE, MBG and LAGE
时间窗: 12 weeks
The effects of Mulberry Twig Alkaloid Tablet and Canagliflozin on the changes of blood glucose fluctuations (including MBG, TIR, TAR, TBR, MAGE, MBG and LAGE) in patients with type 2 diabetes mellitus by FGM.
次要结局
- Concentration of C-peptide, Insulin, glucagon and HOMA-IR(12 weeks)
- Concentration of adiponectin, leptin,IL-1,IL-6 andTNF-α(12 weeks)
- Concentration of the TC, TG, LDL, HDL and FFA(12 weeks)