Investigators will be evaluating the comparative effectiveness and safety of a new therapy for treatment of diabetes mellitus (DM). To do so, the team will devise appropriate and novel methodology for the study of the effectiveness of exenatide (Byetta®
), an incretin-mimetic, using large administrative datasets. The study team will include experts in the design of observational studies and analysis of large data sets, as well as experts in DM research. The project will use unique databases, which include information on patient characteristics, medication use, clinical outcomes, and resource utilization. The study will examine the initial pattern of use of exenatide. The study will identify comparison groups of patients with DM, and estimate outcome rates during a three to six month period, focusing on clinical outcomes such as medication-related adverse events, mortality, and resource utilization including hospitalization rates and costs. The study will compare the outcome rates in the comparison populations to the rates among recipients of this new therapy. As these will be observational studies, the investigators will carefully address risk adjustment by using propensity scores, sensitivity analyses or other methods. The study will be one of the first efforts to use a large administrative dataset to evaluate the diffusion, effectiveness and safety of a new medication in its first year of use. The methods developed and results obtained should have wide applicability for future research, policy, and practice.