Grant: New Investigator Salary Award - PA: Drug Safety and Effectiveness

Medications used to treat type 2 diabetes are studied extensively prior to approval by regulatory authorities. However, our understanding of a medication's effectiveness in an everyday clinical setting, the chance of rare adverse effects, and its long-term effects is very limited. In other words for individuals living with type 2 diabetes, a medication's potential to cause unintended side effects - and even any beneficial effects it might have on reducing the complications of diabetes long-term (e.g. cardiovascular disease) - are unknown when the medication is first marketed. Given the increasing numbers of people with type 2 diabetes worldwide, an evaluation of the postmarketing safety and effectiveness of medications for type 2 diabetes is essential for improving the care for these individuals. My research over the next 5 years will focus on studying the risks and benefits of both the newest antidiabetic medications (the incretins) and older, understudied medications (insulin). I propose to study these medications using a database of detailed healthcare records for individuals with type 2 diabetes. This database will include information on: prescription medication use, diagnoses, laboratory tests, and hospitalizations and death. Using the information in the database, I will assess the risk and benefits of incretin-based therapies and insulin therapy compared to other commonly used antidiabetic therapies. Moreover, I will systematically assess if there are any specific effects within certain groups of patients such as males and females, those with poor or normal kidney function, and other sociodemographic, clinical, and health system characteristics. Ultimately, my research program will contribute to our understanding of the real world effects of antidiabetic medications, and will inform patients, clinicians, and policymakers of the potential harms and benefits of these medications when used in everyday clinical practice.