Alogliptin (Nesina) Tablets Special Drug Use Surveillance: Mild Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 19,192
- 主要终点
- Percentage of Participants Who Had One or More Adverse Events
研究概览
简要总结
The purpose of this study is to examine the safety and efficacy of long-term treatment with alogliptin (Nesina) in patients with mild type 2 diabetes mellitus in the routine clinical setting.
详细描述
This is a special drug use surveillance on long-term use of alogliptin, designed to investigate the safety and efficacy of treatment with alogliptin in patients with mild type 2 diabetes mellitus in the routine clinical setting.
Participants will be patients with mild type 2 diabetes mellitus. The planned sample size is 20,000.
The usual adult dosage for oral use is 1 alogliptin tablet (25 mg of alogliptin) once daily.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Haemoglobin A1c (HbA1c) [Japan Diabetes Society (JDS) value] ≤7.0% at the time of enrolment (within 3 months before initiation of alogliptin therapy), regardless of the use of antidiabetic medication.
排除标准
- •Patients contraindicated for alogliptin.
- •Patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus.
- •Patients with severe infection, pre- or post-operative patients, or patients with serious traumatic injury.
- •Patients with a history of hypersensitivity to any ingredient of alogliptin.
研究组 & 干预措施
Alogliptin
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months. Participants will receive interventions as part of routine medical care.
干预措施: Alogliptin (Drug)
结局指标
主要结局
Percentage of Participants Who Had One or More Adverse Events
时间窗: Up to Month 36
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
时间窗: Baseline, and final assessment point (up to Month 36)
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at final assessment point (up to Month 36) relative to baseline.
次要结局
- Change From Baseline in Fasting Blood Glucose(Baseline, and final assessment point (up to Month 36))