NCT05667220招募中4 期
Efficacy of Combination Therapy With Sitagliptin and Beidougen Capsule in Chinese Patients With Type 2 Diabetes
Beijing Chao Yang Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年12月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Fasting blood glucose change
研究概览
简要总结
The study was an interventional non-randomized controlled study and was divided into a Sitagliptin monotherapy (100 mg Qd) group and a Sitagliptin (100mg Qd)+Beidougen capsule (60mg Tid) combination treatment group for one week.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-65 years with a first diagnosis of type 2 diabetes
- •Diagnostic criteria HbA1c ≥ 7%
排除标准
- •The positive of diabetes antibodies
- •Anti-diabetic drugs therapy before participation
- •Pancreatitis
- •Coronary artery disease
- •Liver function impairment
- •Renal function impairment
- •History of intestinal surgery
- •Chronic hypoxic diseases (emphysema and cor pulmonale)
- •Infectious disease
- •Hematological disease
- •Systemic inflammatory disease
- •Ingesting agents known to influence glucose or lipid metabolism
- •Any antibiotics or probiotics in the past three months prior to the study
研究组 & 干预措施
Sitagliptin monotherapy group (Group A)
Active Comparator
干预措施: Sitagliptin (Drug)
Sitagliptin combined with Beidougen capsule treatment group (Group B)
Experimental
干预措施: Sitagliptin combined with Beidougen capsule (Drug)
结局指标
主要结局
Fasting blood glucose change
时间窗: Changes in fasting blood glucose from baseline to 1 week treatment
Fasting blood glucose (FBG) levels (mmol/L) were analyzed by an autoanalyzer (Hitachi 747, Roche Diagnostics, Germany) at the Central Chemistry Laboratory of Beijing Chaoyang Hospital affiliated with Capital Medical University.
次要结局
- Serum GLP-1 change(Changes in serum GLP-1 from baseline to 1 week treatment)
- Fecal DPP4 activity change(Changes in fecal DPP4 activity from baseline to 1 week treatment)
研究者
Guang Wang
Beijing Chao Yang Hospital
Beijing Chao Yang Hospital
研究点 (1)
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