QTERN (SAXAGLIPTIN/DAPAGLIFLOZIN FDC) Regulatory Post-Marketing Surveillance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 679
- 试验地点
- 1
- 主要终点
- • Incidence of unexpected adverse drug reactions in patients who are treated with Qtern
研究概览
简要总结
This is a local, prospective, non-interventional, regulatory post-marketing surveillance study. Adult patients with type 2 diabetes mellitus who are initiating Qtern as indicated by the MFDS will be included. 600 patients are followed up 12 weeks and at least 60 patients of the 600 patients are followed up 24 weeks. Patients will be treated as part of routine practice at Korean healthcare centers by accredited physicians. In this study, patients will receive Qtern as indicated in the locally approved prescribing information.
详细描述
As part of a post approval commitment, the MFDS has requested a post-marketing surveillance program to characterize safety in patients who are treated with Qtern for T2DM by physicians in the normal clinical practice setting. This study is designed to confirm assess the known safety profile or identify previously unsuspected adverse reactions and to evaluate the effectiveness of Qtern under conditions of routine daily medical practice in Korea.
The primary objective of this study is :
Descriptive analysis of the proportion of adverse events (AEs) and serious adverse events (SAEs) in patients who are treated with Qtern for type 2 diabetes mellitus by physicians in the normal clinical practice setting over a period of 12 and 24 weeks.
The secondary objectives of this study are:
To follow the changes of the hemoglobin A1c (HbA1c), fasting plasma glucose (FPG), 2-hr post-prandial glucose (PPG-2hr), blood pressure, abdominal circumference and body weight and self-reported data in this cohort of patients from baseline to completion of the study.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 19 years and older
- •Patients with T2DM eligible for treatment with Qtern as indicated in the locally approved prescribing information
- •Patients with evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
排除标准
- •Patients treated with Qtern outside of the locally approved Prescription Information in Korea
- •Patients with contraindications for the use of Qtern (as described in the Korean Prescription Information)
结局指标
主要结局
• Incidence of unexpected adverse drug reactions in patients who are treated with Qtern
时间窗: 12 or 24 weeks
• Incidence (%) of AEs in patients who are treated with Qtern
时间窗: 12 or 24 weeks
• Severity of unexpected adverse drug reactions in patients who are treated with Qtern
时间窗: 12 or 24 weeks
• Severity of AE in patients who are treated with Qtern
时间窗: 12 or 24 weeks
• Nature of AE in patients who are treated with Qtern
时间窗: 12 or 24 weeks
• Incidence (%) of SAEs in patients who are treated with Qtern
时间窗: 12 or 24 weeks
• Nature of unexpected adverse drug reactions in patients who are treated with Qtern
时间窗: 12 or 24 weeks
次要结局
- • Change in abdominal circumference during the observation period(12 or 24 weeks)
- • Change of PPG-2hr during the observation period(12 or 24 weeks)
- • Change in blood pressure during the observation period(12 or 24 weeks)
- • Change in body weight during the observation period(12 or 24 weeks)
- • Change in HbA1c during the observation period(12 or 24 weeks)
- • Change in FPG during the observation period(12 or 24 weeks)
- • Overall assessment on the outcome of the treatment by investigators(12 or 24 weeks)
- • Clinically significant results from blood chemistry test(12 or 24 weeks)
- • Clinically significant results from complete blood count test(12 or 24 weeks)
- • Clinically significant results from urinalysis(12 or 24 weeks)