NCT02949193已完成3 期
A Phase III Clinical Trial to Investigate the Efficacy and Safety of Evogliptin When Added to Ongoing Metformin Monotherapy in Patients With Type 2 Diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 222
- 试验地点
- 1
- 主要终点
- HbA1c
研究概览
简要总结
This is a randomized, double-blind, active-controlled, phase III clinical trial to investigate the efficacy and safety of evogliptin when added to ongoing metformin monotherapy in patients with type 2 diabetes who have inadequate glycemic control
详细描述
- Evogliptin 5mg Group: Administration with Evogliptin 5mg add-on to metformin for 0-52 weeks.
- Sitagliptin 100mg Group: Administration with Sitagliptin 100mg add-on to metformin for 0-24 weeks, and with Evogliptin 5mg add-on to metformin for 24-52 weeks.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with 6.5%≤HbA1c≤11.0% at screening
- •Subjects treated with 1,000mg/day or higher dose of metformin for at least 6 weeks prior to screening among people treated with metformin monotherapy for at least 12 weeks before screening
- •Subjects with 20kg/m2≤BMI≤40kg/m2 at screening
排除标准
- •Subjects with fasting plasma glucose≥270mg/dL at screening
- •Patients with type 1 diabetes mellitus, secondary diabetes mellitus or gestational diabetes mellitus
- •Subjects with history of myocardial infarction, cerebral infarction within 6 months prior to screening
- •Subjects with ALT and AST 2.5 times or higher than upper normal range
研究组 & 干预措施
evogliptin
Experimental
evogliptin 5mg qd add-on to metformin
干预措施: evogliptin (Drug)
sitagliptin
Active Comparator
sitagliptin 100mg qd add-on to metformin
干预措施: Sitagliptin (Drug)
结局指标
主要结局
HbA1c
时间窗: Change from baseline at 24 week
unit: %
次要结局
- HbA1c response rate(Change from baseline at 24 weeks)
- fasting plasma glucose(Change from baseline at 24 week)
- HOMA-beta(Change from baseline at 24 week)
研究者
研究点 (1)
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