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

项目概要/摘要 Jung-Im Shin，医学博士，博士，是约翰霍普金斯大学流行病学系的助理科学家。 彭博公共卫生学院。她寻求K 01指导研究科学家发展奖， 为了获得基本技能和指导的研究经验，作为一个独立的职业生涯的研究 药物流行病学和糖尿病领域的科学家。该研究提案详细列出了一项五年计划 包括深入的培训，在新的因果推理方法，导师博士摩根格拉姆，医学博士， 博士和博士伊丽莎白塞尔文，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 1）描述在糖尿病患者中二线治疗的真实流行病学， 二甲双胍单药治疗; 2）评价5类二线治疗的真实世界有效性， 二甲双胍单药治疗后类似糖尿病患者的高血糖管理;以及3） 评价不良事件的真实风险和5类第二类药物的长期临床结局的获益- 二甲双胍单药治疗后类似糖尿病患者的一线治疗。近期职业目标包括 掌握应用目标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整合的学术课程。长期的，申医生 旨在领导独立的研究项目，调查最佳治疗和决策，以改善 2型糖尿病患者的健康状况。完成拟议目标将提供重要信息 与美国约三千万2型糖尿病患者相关。2型糖尿病与 发病率和死亡率都很高。尽管一线治疗存在共识，但仍存在 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。更好地了解不同类别二线的风险和收益 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.