NCT04180813终止不适用
A Non-interventional Study of Patient Medication Adherence and Treatment Effectiveness Among New Users of Linagliptin and Acarbose in the Real-world Clinical Setting in China
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 85
- 试验地点
- 10
- 主要终点
- Proportion of T2DM patients with high medication adherence at Week 24
研究概览
简要总结
Non-interventional cohort study based on newly collected data under routine medical practice of a total of 500 Diabetes Mellitus, Type 2 patients
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient should fully know and understand the content of consent form, and the patient is willing and able to sign an informed consent form
- •Chinese outpatients with confirmed T2DM
- •Patients of ≥ 18, < 80 years old
- •Patients currently use metformin monotherapy ≥ 1500 mg/day or maximum tolerable dose and whose glucose levels are not adequately controlled
- •HbA1c ≥ 7% and < 12%
- •New user* linagliptin or acarbose as combination therapy with metformin ≥ 1500 mg/day or maximum tolerable dose *New user defined as a T2DM patient initiating linagliptin or acarbose as an add-on therapy.
- •These are patients who are on metformin and whose glucose levels are not adequately controlled.
排除标准
- •Type 2 diabetes mellitus patients who previously used any DPP-4 inhibitor/ GLP-1 receptor agonist at index date or any AGI at index date, are not eligible to participate. Also excluded are patients who currently using any glucose-lowering agent as monotherapy other than metformin.
- •Patients with clinically significant acute major organ or systemic disease or other condition judged by the investigator that would create difficulty for the 24-week follow-up.
- •Patients who participated in a clinical trial within 2 months prior to study enrolment date.
- •Patients diagnosed with Type 1 diabetes mellitus, secondary diabetes or gestational diabetes.
- •Current treatment with systemic steroids at time of informed consent or within 6 weeks prior to informed consent.
- •Patients with known significant GI disease as judged by the study physician.
研究组 & 干预措施
Linagliptin Initiators
干预措施: Linagliptin (Drug)
Acarbose Initiators
干预措施: Acarbose (Drug)
结局指标
主要结局
Proportion of T2DM patients with high medication adherence at Week 24
时间窗: 24 weeks
次要结局
- Patient satisfaction by Diabetes Treatment Satisfaction Questionnaire (DTSQ) among linagliptin and acarbose initiators. The DTSQ would be completed at routine physician visits since initiation of the drug(24 weeks)
- To compare the composite endpoint (proportion of achieving HbA1c < 7.0% without gastrointestinal adverse events (GI AEs) and without an investigator defined hypoglycaemic event)(24 weeks)
- The effectiveness of linagliptin and acarbose on glycemic control evaluated by reducing HbA1c during a 24 week follow-up in two groups(24 weeks)
- Proportion of T2DM patients achieving a therapeutic glycemic response defined as HbA1c < 7.0% or a lowering of HbA1c ≥ 0.5%(24 weeks)
研究者
研究点 (10)
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