临床试验/NCT07229534

NCT07229534尚未招募4 期

A Phase IV Clinical Trial to Evaluate the Efficacy and Safety of DA-5218 in Patients With Type 2 Diabetes Inadequately Controlled With Metformin

Dong-A ST Co., Ltd.0 个研究点目标入组 238 人开始时间: 2025年11月1日最近更新: 2025年11月17日

干预措施

试验速览

阶段: 4 期
状态: 尚未招募
发起方: Dong-A ST Co., Ltd.
入组人数: 238
主要终点: Change from baseline of HbA1c(%)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

This study is a multicenter, double-blind, active-controlled, randomized, parallel, phase IV clinical trial to evaluate the efficacy and safety of DA-5218 in patients with type 2 diabetes who have inadequate glycemic control with metformin

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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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

•7.0%≤HbA1c≤10.5% and fasting glucose≤270mg/dL
•Treated with 1,000mg/day dose of metformin for at least 8 weeks

排除标准

•Type 1 diabetes mellitus, secondary diabetes mellitus or gestational diabetes mellitus
•eGFR<45mL/min/1.73m2
•ALT and AST 3 times or higher than upper normal range
•Determined by investigator as unfit to participate in a clinical trial due to other reasons

研究组 & 干预措施

DA-5218

Experimental

干预措施: DA-5218 (Drug)

DA-5218-C

Active Comparator

干预措施: DA-5218-C (Drug)

结局指标

主要结局

Change from baseline of HbA1c(%)

时间窗: 24 weeks

次要结局

未报告次要终点

研究者

发起方

Dong-A ST Co., Ltd.

申办方类型

Industry

责任方

Sponsor

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