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临床试验/NCT06495281
NCT06495281已完成不适用

A Observational Study to Evaluate Effectiveness, Safety of Triple Combination Therapy of Zemidapa and Metformin in Patients With Type 2 DM Who Received Double or Triple Combination Therapy Including DPP4-inhibitor Other Than Gemigliptin

LG Chem1 个研究点 分布在 1 个国家目标入组 2,044 人开始时间: 2023年10月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
2,044
试验地点
1
主要终点
change from baseline of HbA1c at 12 weeks

研究概览

简要总结

The aim of this study is to evaluate the effectiveness and safety of the triple combination therapy of Zemidapa Tab. and Metformin in patients with type 2 diabete mellitus

研究设计

研究类型
Observational
观察模型
Cohort
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

  • type 2 DM Patients who are receiving one of the following three therapies during which the patients are prescribed with Zemidapa Tab. for the first time at the discretion of the attending physician:
  • Double combination therapy (Metformin and a DPP-4 inhibitor other than Gemigliptin)
  • Triple combination therapy (Metformin, a DPP-4 inhibitor other than Gemigliptin, and a SGLT-2 inhibitor)
  • Triple combination therapy (Metformin, a DPP-4 inhibitor other than Gemigliptin, and Sulfonylurea [SU])
  • patients with HbA1c results and who signed the written consent form

排除标准

  • - Patients contraindicated for the approved use of Zemidapa Tab. or have participated in another clinical study within 12 weeks

结局指标

主要结局

change from baseline of HbA1c at 12 weeks

时间窗: baseline, 12 weeks

次要结局

  • the rate of subjects who reached the target value of less than 7% HbA1c(12 weeks)

研究者

发起方
LG Chem
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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