NCT02567994已完成3 期
Efficacy and Safety of Teneligliptin Versus Sitagliptin as add-on Therapy to Metformin Plus Glimepiride in T2DM Patinets With Inadequate Glycemic Control
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Handok Inc.
- 入组人数
- 201
- 试验地点
- 1
- 主要终点
- Change of HbAlc from baseline at Week 24
研究概览
简要总结
After a screening, a 2-week, single-blind placebo run-in, 200 patients will be randomized in a 1 : 1 ratio to the addition of either once-daily Teneligliptin 20mg or sitagliptin 100mg to ongoing stable doses of glimepiride in combination with metformin for 24 weeks.
详细描述
Subjects will visit the centers on Week 4, 12 and 24 during the entire 24-week treatment period. Total study duration will be approximately 28weeks and the subjects will be to practice exercise/diet control together.
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
- •Patients with Type 2 Diabetes Mellitus
- •Adults aged ≥ 19 years old
- •Patients with HbA1c 7%~11% at Screening and Run-in visit
排除标准
- 未提供
研究组 & 干预措施
Teneligliptin
Experimental
20mg qd
干预措施: Teneligliptin (Drug)
Sitagliptin
Active Comparator
100mg qd
干预措施: Teneligliptin (Drug)
结局指标
主要结局
Change of HbAlc from baseline at Week 24
时间窗: 24 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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