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Validation of the diabetes microsimulation model in the HARMONY trial

Validation of the diabetes microsimulation model in the HARMONY trial

Hui Shao

University of Florida College of Pharmacy

13 March 2020

Most of the diabetes simulation model was developed based on data from the UK Prospective Diabetes Study (UKPDS) trials, a study started in the 70s. Several validation studies were conducted recently, assessing the prediction performance of those old models in recently conducted trials. The results show that the old simulation models failed to achieve good prediction accuracy when modeling new trials, and cannot capture the treatment effect of newer drugs on primary/secondary outcomes in those trials.The Building, Relating, Assessing, and Validating Outcomes (BRAVO) model is a patient-level microsimulation model mapping the progression of diabetes from onset to death. Unlike old diabetes models, the BRAVO diabetes model was developed using data from Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. Compared to the UKPDS trial, the ACCORD trial was more recent and used more newly developed drugs such as GLP-1 receptor agonist,which is a type of non-insulin medication that is used in combination with diet and exercise to help treat type 2 diabetes and to aid in weight loss.There are interests in the microsimulation field to examine whether this newly developed model can correctly model the recent trials and capture the treatment effect of GLP-1 receptor agonists. The Harmony Outcomes trial is a multi-center, double-blind, randomized, placebo-controlled trial, testing the cardiovascular (CV) safety of albiglutide (GLP-1 receptor agonist) among patients with type 2 diabetes, who were at high risk of CV events. This proposed study will validate the BRAVO diabetes model in the Harmony Outcomes trial.

[{ "PostingID": 19799, "Title": "GSK-GLP116174", "Description": "A long term, randomised, double blind, placebo-controlled study to determine the effect of albiglutide, when added to standard blood glucose lowering therapies, on major cardiovascular events in patients with Type 2 diabetes mellitus" }]

Statistical Analysis Plan