NCT05504239已完成3 期
A Multicenter, Randomized, Placebo-controlled, Parallel Group, Double-blind, Phase III Study to Evaluate the Efficacy and Safety of Teneligliptin in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control With Metformin and Empagliflozin
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
- 235
- 试验地点
- 1
- 主要终点
- Changes from baseline HbA1c at week 24
研究概览
简要总结
The objective of this study is to evaluate the efficacy and safety of teneligliptin 20 mg orally administered once daily for 24 weeks compared with placebo in patients with type 2 diabetes mellitus who have inadequate glycemic control with empaglyflozin and 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
- •Patients with Type II diabetes mellitus aged 19 years or older
- •Subjects with 7.0%≤HbA1c≤10.5% at screening visit
- •Subjects with fasting plasma glucose ≤ 270mg/dL at screening visit
排除标准
- •Subjects with type 1 diabetes mellitus or secondary diabetes
- •Subjects with history of diabetic ketoacidosis, diabetic coma or pre-coma, lactic acidosis, and acute or chronic acidosis within 6 months prior to the screening visit
- •Subjects who have been administered with weight-loss drug (e.g., orlistat, phentermine/topiramate, lorcaserin)
- •Body mass index greater than 40 kg/m2 at the screening visit
- •Subjects with heart failure (Class III-IV of NYHA classification) or arrhythmia that requires treatment
研究组 & 干预措施
Teneligliptin 20 mg
Experimental
Once daily for 24 weeks
干预措施: Teneligliptin (as Teneligliptin Hydrobromide) 20 Mg Oral Tablet (Drug)
Teneligliptin placebo
Placebo Comparator
Once daily for 24 weeks
干预措施: Teneligliptin Placebo Oral Tablet (Drug)
结局指标
主要结局
Changes from baseline HbA1c at week 24
时间窗: Baseline (week 0) and week 24
次要结局
- Changes from baseline FPG at week 24(Baseline (week 0) and week 24)
- Percentage of subjects achieving the HbA1c goals (HbA1c < 7.0% or < 6.5%) at week 24(Baseline (week 0) and week 24)
- Changes from baseline in BMI at week 24(Baseline (week 0) and week 24)
研究者
研究点 (1)
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