A Prospective, Non-Interventional Study of the Use of Alogliptin and Alogliptin Fixed-Dose Combinations With Pioglitazone and With Metformin in Standard Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 593
- 主要终点
- Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Month 6
研究概览
简要总结
The purpose of this study is to observe alogliptin and alogliptin fixed-dose combinations (FDCs) utilization patterns, as well as clinical response to treatment with alogliptin or alogliptin FDCs, in standard clinical practice.
详细描述
The drug being studied in this study is called alogliptin and alogliptin FDCs. Alogliptin and alogliptin FDCs is being researched to treat people who have diabetes mellitus type 2. This study will look at the glycosylated hemoglobin (HbA1c) level dynamics in participants with diabetes mellitus type 2.
The study enrolled 593 patients. Alogliptin and alogliptin FDCs will be prescribed by the physician as part of participants' T2DM treatment program (independent of participation in this study).
This multi-center study will be conducted in China. The overall duration of study for observation will be approximately 6 months, or up to loss to follow-up or death, whichever occurs first. Participants will make multiple visits to the clinic as per regular doctor's appointments.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has a diagnosis of T2DM.
- •Has made the decision, along with his/her treating physician, to begin treatment with alogliptin or alogliptin fixed-dose combinations (FDCs).
- •Has an glycated hemoglobin (HbA1c) value recorded at most 3 months before initiation of treatment with alogliptin or alogliptin FDCs.
- •Alogliptin or alogliptin FDCs is prescribed according to the approved label for China and Hong Kong.
排除标准
- •Has gestational diabetes or type 1 diabetes mellitus.
- •Has used Dipeptidyl peptidase-4 inhibitors (DPP-IV inhibitors) or Glucagon like peptide-1 agonists (aGLP-1) within the 3 months prior to the start of alogliptin or alogliptin FDCs treatment.
研究组 & 干预措施
Alogliptin or Alogliptin Fixed Dose Combinations (FDCs)
Participants with type 2 diabetes mellitus (T2DM) who received alogliptin or alogliptin FDCs, orally, prescribed by the physician as part of participants' T2DM treatment program (independent of participation in this study) were observed for approximately 6 months, or up to loss to follow-up or death, whichever occurred first.
干预措施: Alogliptin (Drug)
Alogliptin or Alogliptin Fixed Dose Combinations (FDCs)
Participants with type 2 diabetes mellitus (T2DM) who received alogliptin or alogliptin FDCs, orally, prescribed by the physician as part of participants' T2DM treatment program (independent of participation in this study) were observed for approximately 6 months, or up to loss to follow-up or death, whichever occurred first.
干预措施: Alogliptin FDC With Pioglitazone (Drug)
Alogliptin or Alogliptin Fixed Dose Combinations (FDCs)
Participants with type 2 diabetes mellitus (T2DM) who received alogliptin or alogliptin FDCs, orally, prescribed by the physician as part of participants' T2DM treatment program (independent of participation in this study) were observed for approximately 6 months, or up to loss to follow-up or death, whichever occurred first.
干预措施: Alogliptin FDC With Metformin (Drug)
结局指标
主要结局
Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Month 6
时间窗: Baseline and Month 6
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 Month 6 relative to baseline. Glycosylated hemoglobin (HbA1c) as a diagnostic criteria of diabetes mellitus is ≥6.5%. A negative change from Baseline indicates improvement.
次要结局
- Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics(Baseline and Month 6)
- Percentage of Participants With a Decrease in HbA1c Level by >0.3% and No Tolerability Findings(Baseline and Month 6)
- Change From Baseline in Fasting Plasma Glucose (FPG) Level Over Time(Baseline and Months 3 and 6)
- Number of Participants With Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)(Baseline up to Month 6)
- Percentage of Participants Who Remain on Treatment With Alogliptin or Alogliptin FDCs(Months 3 and 6)
- Percentage of Participants With a Decrease in HbA1c Level by <7.0%(Baseline and Month 6)
- Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level Over Time(Baseline and Months 3 and 6)
- Time to Alogliptin or Alogliptin FDCs Dose Escalation or Dose Reduction(Months 3 and 6)