Forxiga (Dapagliflozin) Regulatory Postmarketing Surveillance
Post-Marketing Surveillance to Evaluate the Safety and Efficacy of Forxiga in Patients With Type 2 Diabetes in Korea
研究概览
地位
条件
详细说明
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.
Study Design: This is a local, prospective, noninterventional, regulatory postmarketing surveillance study. Adult patients with type 2 diabetes mellitus who are initiating Forxiga as indicated by the Ministry of Food and Drug Safety (MFDS) will be included. Patients will be followed for a minimum of 12 weeks or a minimum 24 weeks. Patients will be treated as part of routine practice at Korean healthcare centers by accredited physicians. In this study, patients will receive 10 mg or 5 mg of Forxiga in conjunction with diet and exercise modifications for the treatment of T2DM.
Study Population: Physicians should enroll adult patients who are diagnosed with T2DM and who initiate treatment with 10 mg of Forxiga, or 5 mg of Forxiga in patients with severe hepatic impairment as a starting dose, for the first time.
Data Collection Methods: and Astra-Zeneca will select medical institutions including relevant departments, such as internal medicine and family medicine, of university hospitals, general hospitals and clinics where the surveillance drug is mainly prescribed and where staff can sufficiently fulfill the objectives of the surveillance and request for surveillance after signing a written contract. Patients' medical records will be data sources in this study. Only if the laboratory test is done as part of standard of care practice and the data are available will the data be collected for this study.
Data Analyses: Statistical analyses will be of explorative and descriptive nature. All analyses will be performed for the total study population who will consist of all patients taking at least one dose of Forxiga. For the safety assessment, occurrences of adverse events (AEs), serious adverse events, adverse drug reactions (ADR), and unexpected adverse drug reactions will be calculated. Severity, actions taken to the surveillance drug, outcome, and causal relationship of AE to the study drug will be analyzed. At the time of the regular reporting and the final reporting, the event count, incidence proportion (that is, the number of patients with any events divided by the number of patients) and incidence rate (number of patients with any events divided by the duration of time patients are followed up in the study) of all the adverse events surveyed during the re-examination period will be summarized, and 95% confidence interval will be presented. Changes in Hemoglobin A1c(HbA1c), Fasting plasma glucose(FPG), and Post-prandial glucose-2 hour(2-hr PPG) before and after administration of Forxiga will be analyzed. At the time of the regular reporting and the final reporting, the event count and effectiveness rate of improvement of lab result (HbA1c, FPG, and PPG), surveyed during the re-examination period will be summarized, and 95% confidence interval will be presented. In order to explore the factors that might influence safety and effectiveness profiles, the cumulative incidence proportion of adverse events and effectiveness rate will be analyzed by patients' background characteristics Sample Size/Power: In accordance with the guidelines provided by the MFDS, at least 3,000 patients will be enrolled. For the overall study population of approximately 3000 patients, the incidence proportion of infrequent adverse events(for example, an incidence proportion of 0.1%) can be estimated with a 95% CI of (0.02, 0.29) (n=3 patients with events).
Limitations/Strengths: The surveillance, with characteristics of a noninterventional, observation study, has no control group and will follow patients in usual clinical practice. Given these conditions, the types of safety and effectiveness data available for collection may be limited compared with other noninterventional clinical trials. This surveillance study will generate results from a wider range of data than those previously derived from the more limited clinical trial setting and will allow for longer follow up among a more varied patient population.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Bucheon-si、大韩民国
- Research Site
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Busan、大韩民国
- Research Site
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Daejeon、大韩民国
- Research Site
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Jeonju-si、大韩民国
- Research Site
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Seoul、大韩民国
- Research Site
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Wonju-si、大韩民国
- Research Site
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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)
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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T2DM patients treated with Forxiga
Korean patients who are at least 18 years old, diagnosed with type2 diabetes and treated with Forxiga according to the approved lable
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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The number and incidence rate of adverse events and serious adverse event including unexpected adverse drug reactions
大体时间:Adverse event will be collected from baseline(Day1) to 3 days after 12 weeks (maximum 16 weeks) or 24 weeks (maximum 30 weeks))
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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.
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Adverse event will be collected from baseline(Day1) to 3 days after 12 weeks (maximum 16 weeks) or 24 weeks (maximum 30 weeks))
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Changes in HbA1c before and after administration of Forxiga
大体时间:Baseline, 12 weeks (maximum 16 weeks), 24 weeks (maximum 30 weeks) in case of long-term surveillance
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Medical records and laboratory test results will be used to determine effectiveness as judged by the investigator.
Changes from baseline to at least 12 weeks (maximum 16 weeks) or 24 weeks (maximum 30 weeks) in case of long-term surveillance will be assessed for the following outcome measure (if assessed during routine clinical practice): HbA1c (Hemoglobin A1c)
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Baseline, 12 weeks (maximum 16 weeks), 24 weeks (maximum 30 weeks) in case of long-term surveillance
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Changes in FPG before and after administration of Forxiga
大体时间:Baseline, 12 weeks (maximum 16 weeks), 24 weeks (maximum 30 weeks) in case of long-term surveillance
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Medical records and laboratory test results will be used to determine effectiveness as judged by the investigator.
Changes from baseline to at least 12 weeks (maximum 16 weeks) or 24 weeks (maximum 30 weeks) in case of long-term surveillance will be assessed for the following outcome measure (if assessed during routine clinical practice): FPG (fasting plasma glucose)
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Baseline, 12 weeks (maximum 16 weeks), 24 weeks (maximum 30 weeks) in case of long-term surveillance
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Changes in 2-hr PPG before and after administration of Forxiga
大体时间:Baseline, 12 weeks (maximum 16 weeks), 24 weeks (maximum 30 weeks) in case of long-term surveillance
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Medical records and laboratory test results will be used to determine effectiveness as judged by the investigator.
Changes from baseline to at least 12 weeks (maximum 16 weeks) or 24 weeks (maximum 30 weeks) in case of long-term surveillance will be assessed for the following outcome measure (if assessed during routine clinical practice): 2-hr PPG (2-hr post-prandial glucose)
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Baseline, 12 weeks (maximum 16 weeks), 24 weeks (maximum 30 weeks) in case of long-term surveillance
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合作者和调查者
赞助
调查人员
- 研究主任:A Ri Kim、AstraZeneca Korea - Medical Affairs
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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