Long-term Use of Alogliptin/Pioglitazone Combination Tablets in Patients With 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
- 3,281
- 主要终点
- Number of Participants Who Experience at Least One Adverse Events
研究概览
简要总结
The purpose of this survey is to examine the safety and efficacy of long-term use of alogliptin/pioglitazone(Liovel) combination tablets in patients with type 2 diabetes mellitus determined as warranting combination therapy with alogliptin benzoate and pioglitazone hydrochloride
详细描述
This is a special drug use surveillance on long-term use of alogliptin/pioglitazone combination tablets. This study is designed to investigate the safety and efficacy of long-term use of alogliptin/pioglitazone combination tablet in patients with type 2 diabetes mellitus in the routine clinical setting.
Participants will be patients with type 2 diabetes mellitus. The planned sample size is 3000.
The usual adult dosage is 1 tablet (containing alogliptin/pioglitazone at either 25 mg/15 mg or 25 mg/30 mg) taken orally once daily before or after breakfast.
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 type 2 diabetes mellitus
排除标准
- •Patients meeting any of the following criteria will be excluded:
- •Patients with current cardiac failure or a past history of cardiac failure
- •Patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus
- •Patients with serious hepatic dysfunction
- •Patients with serious renal dysfunction
- •Patients with severe infection, pre- or post-operative patients, or patients with serious traumatic injury
- •Patients with a history of hypersensitivity to any ingredients of Alogliptin/Pioglitazone
- •Pregnant or possibly pregnant women
研究组 & 干预措施
Alogliptin/Pioglitazone combination tablets
Alogliptin/Pioglitazone combination tablets, taken orally, once daily for up to 12 months. Participants received interventions as part of routine medical care.
干预措施: Alogliptin/Pioglitazone (Drug)
结局指标
主要结局
Number of Participants Who Experience at Least One Adverse Events
时间窗: Up to 12 Months
Changes From Baseline in Glycosylated Hemoglobin (HbA1c)
时间窗: Baseline and Month 1, 3, 6, 12 and final assessment (up to 12 Months)
Reported data are changes in HbA1c from baseline at Month 1, 3, 6, 12 and final assessment (up to 12 months).
次要结局
- Changes From Baseline in Fasting Blood Glucose (FBG)(Baseline and Month 1, 3, 6, 12 and final assessment (up to 12 Months))