Specified Drug-Use Survey of Alogliptin and Metformin Hydrochloride Combination Tablets "Survey on Long-term Use in Type 2 Diabetes Mellitus Patients With Renal or Hepatic Impairment or Advanced Age"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,026
- 试验地点
- 1
- 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 survey is to evaluate the long-term safety and efficacy of the alogliptin and metformin hydrochloride combination tablet in type 2 diabetes mellitus patients with renal impairment (mild), hepatic impairment (mild or moderate), or advanced age (65 years and more) in the routine clinical setting.
详细描述
The drug being tested in this survey is called alogliptin and metformin hydrochloride combination tablet. This tablet is being tested to treat people who have type 2 diabetes mellitus with renal impairment (mild), hepatic impairment (mild or moderate), or advanced age (65 years and more).
This survey is an observational (non-interventional) study and will look at the long-term safety and efficacy of the alogliptin and metformin hydrochloride combination tablet in the routine clinical setting. The planned number of observed patients will be approximately 600.
This multi-center observational trial will be conducted in Japan.
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
- •Participants should meet one or more of the following:
- •Have renal impairment (mild)
- •Have hepatic impairment (mild or moderate)
- •Elderly (aged 65 years or more)
排除标准
- •Participants with any contraindication for study drug.
研究组 & 干预措施
Alogliptin and Metformin hydrochloride
Alogliptin 25 mg and metformin hydrochloride 500 mg, combination tablet, orally, once daily for up to 12 months. Participants received interventions as part of routine medical care.
干预措施: Alogliptin and Metformin hydrochloride (Drug)
结局指标
主要结局
Percentage of Participants Who Had One or More Adverse Events
时间窗: Up to 12 months
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
次要结局
- Change From Baseline in Glycosylated Hemoglobin (HbA1c)(Baseline, up to final assessment point (up to Month 12))
- Change From Baseline in Fasting Blood Glucose(Baseline, up to final assessment point (up to Month 12))
- Change From Baseline in Fasting Insulin Level(Baseline, up to final assessment point (up to Month 12))