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临床试验/NCT04326166
NCT04326166Unknown不适用

Multi-center, Open, Non-intervention and Observational Study to Evaluate the Efficacy and Safety of Suganon Tab. or Sugamet XR Tab. in Patients With Type 2 Diabetes

Dong-A ST Co., Ltd.1 个研究点 分布在 1 个国家目标入组 1,971 人开始时间: 2020年3月25日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
1,971
试验地点
1
主要终点
Change in HbA1c

研究概览

简要总结

Multi-center, open, non-intervention and observational study to Evaluate the efficacy and safety of Suganon tab. or Sugamet XR tab. in patients with Type 2 diabetes

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The subject is aged ≥19 years
  • The subject has type 2 diabetes mellitus

排除标准

  • The subject has a contraindication

研究组 & 干预措施

Group A

Patients who receive Double therapy or Insulin

干预措施: Evogliptin (Drug)

Group B

Patients who receive DPP-4 inhibitor

干预措施: Evogliptin (Drug)

Group C

Drug-naïve patients

干预措施: Metformin and Evogliptin (Drug)

结局指标

主要结局

Change in HbA1c

时间窗: at 12 weeks

To assess change from baseline in HbA1c

次要结局

  • Change in HbA1c(at 24 weeks)
  • Change in FPG(at 12 and 24 weeks)
  • The percentage of patients with HbA1c <7.0% and <6.5%(at 12 and 24 weeks)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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