A Randomized, Open-label, Active-controlled, Parallel, Multicenter, Phase IV Clinical Trial to Compare the Efficacy and Safety of Switching Metformin+SGLT2-i+Dipeptidyl Peptidase-4-inhibitor(DPP-4-i) to Metformin+SGLT2-i+TZD in Patients With Type 2 Diabetes
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- HbA1c (%) change at 24 weeks compared to the baseline (Visit 2)
研究概览
简要总结
This is a randomized, open-label, active-controlled, parallel, multicenter, phase IV clinical study evaluating the efficacy and safety of switching Metformin+SGLT2-i+DPP4-i to Metformin+SGLT2-i+TZD in patients with type 2 diabetes.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has voluntarily agreed to participate in this clinical trial.
- •Adults over 19 years of age
- •Diagnosed with type 2 diabetes
排除标准
- •Has severe renal and liver disorders
- •Has type 1 diabetes
- •Those who are participating or have participated in other clinical trials and administered their investigational products within 8 weeks before the screening date for this study
- •Those who are deemed ineligible to participate in the study by the investigator
研究组 & 干预措施
Metformin + Dapagliflozin 10mg/Pioglitazone 30mg
One tablet of Metformin and one tablet of Dapagliflozin 10mg/Pioglitazone 30mg administered orally once daily for 24 weeks.
干预措施: Dapagliflozin/Pioglitazone (Drug)
Metformin + Dapagliflozin 10mg/Sitagliptin 100mg
One tablet of Metformin and one tablet of Dapagliflozin 10mg/Sitagliptin 100mg administered orally once daily for 24 weeks.
干预措施: Dapagliflozin/Sitagliptin (Drug)
Metformin + Dapagliflozin 10mg/Sitagliptin 100mg
One tablet of Metformin and one tablet of Dapagliflozin 10mg/Sitagliptin 100mg administered orally once daily for 24 weeks.
干预措施: Metformin (Drug)
Metformin + Dapagliflozin 10mg/Pioglitazone 30mg
One tablet of Metformin and one tablet of Dapagliflozin 10mg/Pioglitazone 30mg administered orally once daily for 24 weeks.
干预措施: Metformin (Drug)
结局指标
主要结局
HbA1c (%) change at 24 weeks compared to the baseline (Visit 2)
时间窗: From baseline to end of treatment at 24 weeks
The mean change of HbA1c at 24 weeks compared to the baseline (Visit 2) is evaluated.
次要结局
未报告次要终点