Kombiglyze XR (Saxagliptin + Metformin XR Fixed Dose Combination) Regulatory Postmarketing Surveillance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 755
- 试验地点
- 1
- 主要终点
- Occurrence of known and unexpected adverse events, especially serious adverse events
研究概览
简要总结
The purpose of this post-marketing surveillance is to investigate and confirm the type and incidence of newly identified adverse events and any other factors affecting safety and efficacy of Kombiglyze Extended release (XR) so that the regulatory authority can manage the marketing approval properly
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •≥ 18 years of age
- •Have diagnosed Type 2 diabetes mellitus (T2DM)
- •Are initiating Kombiglyze XR treatment within the approved Korean indications
排除标准
- •Being treated for an indication not approved for the use of Kombiglyze XR in Korea
- •Is contraindicated for the use of Kombiglyze XR as described in the Korean label
结局指标
主要结局
Occurrence of known and unexpected adverse events, especially serious adverse events
时间窗: 30 days after last dose of study drug (Approximately up to 4.5 years)
Effectiveness of Kombiglyze XR as assessed by change from baseline in Hemoglobin A1c (HbA1c), Fasting plasma glucose (FPG), and 2-hour post-prandial glucose (2-hr PPG)
时间窗: Baseline and Week 24 (for patients that have a post Week 12 follow-up visit)
Incidence of adverse events under the routine drug use
时间窗: 30 days after last dose of study drug (Approximately up to 4.5 years)
次要结局
- Safety information related to overdose, drug-to-drug interaction and laboratory abnormalities based on incidence rates of AEs(Approximately up to 4.5 years)
- Safety information related to factors (eg, gender, demographics etc) that may affect the effectiveness of the drug based on incidence rates of AEs(Approximately up to 4.5 years)
- Safety information related to factors (eg, gender, demographics etc) that may affect the safety of the drug based on incidence rates of AEs(Approximately up to 4.5 years)