NCT04653779Unknown4 期
A Multi-center, Open-label, Single-arm, Phase IV Clinical Trial to Evaluate the Preference Regarding Convenience of Medication, Efficacy and Safety After Switching to SUGAMET®XR Tablet 5/1000mg in Patients With Type 2 Diabetes and Renal Diseases
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- The preference regarding convenience of medication
研究概览
简要总结
Multi-center, open-label, single arm study to Evaluate the preference regarding convenience of medication, efficacy and safety of Sugamet XR tab. 5/1000mg in patients with Type 2 diabetes and renal diseases
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥60 years
- •Subjects with type 2 diabetes mellitus
- •Subjects treated with DPP-4 inhibitor and 1,000mg/day dose of metformin 1T/qd for at least 8 weeks prior to screening
- •Subjects with HbA1c≤7.5% at screening
- •Subjects with 45mL/min/1.73m2≤eGFR≤90mL/min/1.73m2 at screening
- •Subjects with fasting glucose≤200 at screening
- •Subjects with 18.5kg/m2≤BMI≤40kg/m2 at screening
排除标准
- •Patients with type 1 diabetes mellitus, secondary diabetes mellitus or gestational diabetes mellitus
- •ESRD or Patients who have kidney dialysis
- •Subjects with ALT and AST 3 times or higher than upper normal range
研究组 & 干预措施
Group A
Experimental
Patients receive Evogliptin 5mg/Metformin 1000mg once a day
干预措施: Evogliptin 5mg/Metformin 1000mg (Drug)
结局指标
主要结局
The preference regarding convenience of medication
时间窗: 12 weeks
Looking back on the experience of participating in the study, which would you prefer, any of the existing DPP-4 inhibitor/metformin 1000mg sustained-release combination drug or the SugarMet® sustained-release tablet 5/1000mg?
次要结局
- Change from baseline in HbA1c (%) After 12 weeks(12 weeks)
- Change from baseline in HbA1C response rate(%) After 12 weeks(12 weeks)
- Change from baseline in Glycated albumin After 12 weeks(12 weeks)
- Change from baseline in e-GFR After 12 weeks(12 weeks)
- Change from baseline in UACR After 12 weeks(12 weeks)
- Change from baseline in HbA1c (%) After 12 weeks NAG(12 weeks)
- Change from baseline in Nephrin After 12 weeks(12 weeks)
- Change from baseline in Cystatin-C After 12 weeks(12 weeks)
- TSQM-9 scores(12 weeks)
研究者
研究点 (2)
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