NCT03793023已完成不适用
Observational Study to Evaluate the Efficacy and Safety of Teneligliptin When Switched From Other DPP-4 Inhibitors in Type 2 DM With Inadequate Glycemic Control
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Handok Inc.
- 入组人数
- 2,983
- 试验地点
- 1
- 主要终点
- Change in HbA1c
研究概览
简要总结
This study is designed as a prospective, observational, multi-centre study to evaluate the efficacy and safety of Teneligliptin when switched from other DPP-4 inhibitors in type 2 DM with inadequate glycemic control
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 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
- 否
入选标准
- •The subject is aged ≥19 years
- •The subject has a documented diagnosis of type 2 diabetes mellitus for at least 3 months at the screening visit.
- •Patient who was treated with same dosage of DPP4 inhibitor for at least 12 weeks prior to baseline visit (if patient who has been treated with DPP4 inhibitor and any other antidiabetic drugs, antidiabetic drugs should also have been kept same dosage for at least 12 weeks prior to baseline.)
- •Patient with HbA1c≥7.0% at baseline visit
- •Patient who can be switched to Teneligliptin instead of using DPP-4 inhibitor for glycemic control based on the investigator's judgment
- •Patient (or legal guardian, if applicable) is informed of the full nature and purpose of the study, including possible risks and side effects, and understand this information, voluntarily signed and dated the written informed consent in compliance with protocol before inclusion in the study
排除标准
- •Patient with hypersensitivity to the Teneligliptin
- •Patient who treat the Teneligliptin prior to baseline visit
- •A pregnant or lactating female patient
结局指标
主要结局
Change in HbA1c
时间窗: at 12 weeks after switching to Teneligliptin
To assess change from baseline in glycated hemoglobin (HbA1c)
次要结局
- Change in HbA1c(at 24, 52 weeks after switching to Teneligliptin)
- Change in FBG(at 12, 24, 52 weeks after switching to Teneligliptin)
- Change in body weight, BMI(at 12, 24, 52 weeks after switching to Teneligliptin)
- Change in lipid profile(Total cholesterol, LDL cholesterol, HDL cholesterol)(at 12, 24, 52 weeks after switching to Teneligliptin)
- The percentage of patients with HbA1c <7.0% and <6.5%(at Weeks 12, 24, and 52 of teneligliptin treatment)
- The percentage of patients with a decrease from baseline in HbA1c(at Weeks 12, 24, and 52 of teneligliptin treatment)
- Safety Outcome(at Weeks 12, 24, and 52 of teneligliptin treatment)
研究者
研究点 (1)
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