NCT05629806招募中3 期
Effect of Acarbose and Fixed Mixture of Pioglitazone and Metformin in Patients With Type 2 Diabetes Receiving Anti-diabetic Monotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Blood glucose fluctuation
研究概览
简要总结
Monotherapy with DPP-IV inhibitors, SGLT-2 inhibitors or insulin secretagogues frequently failed to maintain blood glucose in patients with type 2 diabtes. It was critical to determine which was more suitable of acarbose versus metformin plus pioglitazone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing to participate in this present study;
- •Patients with type 2 diabetes receiving stable monotherapy of DPP-IV inhibitors, SGLT-2 inhibitors or insulin secretagogues for more than 3 months;
- •Screening glycated hemoglobin (HbA1c) between 7.0% and 10.0%;
- •Regular diet and exercise;
- •Body mass index (BMI) ≥ 18.5 kg/m2
排除标准
- •Intolerance of metformin, pioglitazone and acarbose;
- •Severe liver disease or elevated transaminases (2.5-fold the upper limit);
- •Renal dysfunction or elevated creatinine (1.3-fold the upper limit);
- •Systemic steroids therapy or other medication influencing cholesterol metabolism in the past 3 months;
- •Infection or stress state in the past 4 weeks;
- •Pregnancy or lactation;
- •Patients otherwise adjudged by the investigator to be inappropriate for inclusion into the study.
研究组 & 干预措施
Metformin plus pioglitazone
Active Comparator
干预措施: Metformin plus pioglitazone (Drug)
Metformin plus pioglitazone
Active Comparator
干预措施: Acarbose (Drug)
Acarbose
Active Comparator
干预措施: Metformin plus pioglitazone (Drug)
Acarbose
Active Comparator
干预措施: Acarbose (Drug)
结局指标
主要结局
Blood glucose fluctuation
时间窗: week 24
change from baseline blood glucsoe fluctuation at end of study
次要结局
未报告次要终点
研究者
研究点 (1)
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