Post-Marketing Surveillance to Evaluate the Safety and Efficacy of Forxiga in Patients With Type 2 Diabetes in Korea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 3,123
- 试验地点
- 1
- 主要终点
- The number and incidence rate of adverse events and serious adverse event including unexpected adverse drug reactions
研究概览
简要总结
This surveillance is a postmarketing commitment following the marketing authorization for Forxiga(dapagliflozin) in accordance with Standards on Re-examination of New Drugs, notified by the MFDS under Article 32, Paragraph 1 and Article 37, Paragraph 3 of Pharmaceutical Affairs Law. MFDS requires that at least 3,000 patients who can be evaluated for safety assessment should be collected within 6 years from 26 Nov 2013 to 25 Nov 2019.
详细描述
Protocol Title: Forxiga (dapagliflozin) Regulatory Postmarketing Surveillance
Department: Korea Medical
Objective(s): The primary objective of this study is to examine the safety profiles of Forxiga in Korean patients with T2DM.
The secondary objective of this study is to examine the effectiveness profiles of Forxiga in Korean patient with T2DM.
The exploratory objective of this study is to identify factors that might be associated with the safety and effectiveness profiles of Forxiga in Korean patient with T2DM.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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 aged 18 years and older
- •Patients with T2DM eligible for treatment with Forxiga 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 Forxiga outside of the locally approved label in Korea
- •Patients with contraindications for the use of Forxiga (as described in the Korean product label)
结局指标
主要结局
The number and incidence rate of adverse events and serious adverse event including unexpected adverse drug reactions
时间窗: Adverse event will be collected from baseline(Day1) to 3 days after 12 weeks (maximum 16 weeks) or 24 weeks (maximum 30 weeks))
All patients should be evaluated if they received at least one dose of the study medication. Safety will be evaluated through: • Incidence of serious adverse events • Incidence of unexpected adverse drug reactions • Identification of AE profile in usual practice • Report of AE in routine office visit or through phone or e-mail follow up • Incidence of nonserious adverse events All AEs that occurred on the surveillance drug treatment or within 3 days after the end of the treatment, whether or not related to the drug, will be recorded. The safety assessment should include all undesirable changes of medical findings (including a clinical test finding) noted during medical visits as needed according to local practice guidelines and all AEs associated with surveillance drug administration.
次要结局
- Changes in FPG before and after administration of Forxiga(Baseline, 12 weeks (maximum 16 weeks), 24 weeks (maximum 30 weeks) in case of long-term surveillance)
- Changes in HbA1c before and after administration of Forxiga(Baseline, 12 weeks (maximum 16 weeks), 24 weeks (maximum 30 weeks) in case of long-term surveillance)
- Changes in 2-hr PPG before and after administration of Forxiga(Baseline, 12 weeks (maximum 16 weeks), 24 weeks (maximum 30 weeks) in case of long-term surveillance)