The Comparative Effectiveness and Safety of Second-line Therapy in Patients with Type 2 Diabetes

项目摘要/摘要 Jung-Im Shin，医学博士，约翰霍普金斯大学流行病学系助理科学家 彭博公共卫生学院。她寻求K01指导研究科学家发展奖 为了获得必要的技能和指导的研究经验，以独立的研究生涯 他是药物流行病学和糖尿病领域的科学家。这项研究提案详细说明了一个五年计划 包括对新的因果推理方法的深入培训，由Morgan Grams博士，MD， 博士和伊丽莎白·塞尔文博士，博士，公共卫生硕士和药物流行病学研究的利用，有效性， 2型糖尿病患者二线治疗的安全性。研究议程的具体目标 是为了：1)描述糖尿病患者二线治疗的真实流行病学 2)评价5种二线治疗方案的真实疗效。 相似的糖尿病患者在二甲双胍单药治疗后的高血糖管理； 评估不良事件的真实风险和对5类第二类患者长期临床结果的好处 二甲双胍单药治疗后相似的糖尿病患者的一线治疗。近期的职业目标包括 掌握应用靶向试验仿真和评估动态治疗方案的效果 罗宾的g-方法通过与研究计划相结合的学术课程。长期的，申博士 旨在领导独立研究计划，调查最佳治疗和决策，以改进 2型糖尿病患者的健康结局。完成拟议的目标将提供重要的信息 与大约3000万美国2型糖尿病患者相关。2型糖尿病与 发病率和死亡率都很高。尽管对一线治疗存在共识，但仍有 二线治疗的最佳选择存在很大的不确定性，建议不一致 跨指导方针。更好地理解不同类别二线的风险和好处 抗糖尿病药物将极大地帮助2型糖尿病患者的临床实践。

PROJECT SUMMARY/ABSTRACT Jung-Im Shin, MD, PhD, is an Assistant Scientist in the Department of Epidemiology at the Johns Hopkins Bloomberg School of Public Health. She seeks a K01 Mentored Research Scientist Development Award in order to obtain essential skills and mentored research experience for an independent career as a research scientist in the field of pharmacoepidemiology and diabetes. The research proposal details a five-year plan consisting of in-depth training in novel causal inference methods, mentorship by Dr. Morgan Grams, MD, PhD, and Dr. Elizabeth Selvin, PhD, MPH, and pharmacoepidemiologic research in utilization, effectiveness, and safety of second-line therapy in patients with type 2 diabetes. The specific aims of the research agenda are to: 1) Describe the real-world epidemiology of second-line therapy among people with diabetes after metformin monotherapy; 2) Evaluate real-world effectiveness of 5 classes of second-line therapy for hyperglycemia management among similar people with diabetes after metformin monotherapy; and 3) Evaluate real-world risks of adverse events and benefits on long-term clinical outcomes of 5 classes of second- line therapy among similar people with diabetes after metformin monotherapy. Immediate career goals include the mastery of applying target trial emulation and estimating the effect of a dynamic treatment regime with Robin’s g-methods through an academic curriculum integrated with the research plan. Long-term, Dr. Shin aims to lead independent research programs investigating optimal treatment and decision-making to improve health outcomes of patients with type 2 diabetes. Completion of the proposed aims will provide vital information relevant to the approximately thirty million U.S. patients with type 2 diabetes. Type 2 diabetes is associated with high levels of morbidity and mortality. Although consensus exists around first-line therapy, there remains great uncertainty regarding the optimal choice of a second-line therapy, with inconsistent recommendations across guidelines. A better understanding of the risks and benefits of different classes of second-line antidiabetic drugs would greatly help clinical practice in patients with type 2 diabetes.