Assessing Risk and Progression of Prediabetes and Type 2 Diabetes to Enable Disease Modification Specific Challenge Current therapies for type 2 diabetes focus on the control of blood glucose levels rather than the modification of the disease. Therefore more robust delineation of clinical risk factors, phenotypes, and molecular biomarkers is needed to identify individuals at risk of rapid progression from prediabetes to type 2 diabetes for disease prevention therapeutic intervention trials. More intensive phenotyping of individuals with type 2 diabetes is needed to characterize rates of disease progression and to identify and validate biomarkers and/or indicators of “rapid failure” of insulin-producing pancreatic beta cells and of cellular targets of insulin-mediated glucose disposition, including hepatocytes, skeletal muscle, and adipocytes. Validation of robust markers of type 2 diabetes disease progression would facilitate patient segmentation for feasible assessments of new therapeutic options for disease modification Scope The overall aim of the project is to discover and validate a molecular taxonomy of type 2 diabetes to enable feasible patient segmentation, clinical trial design, and regulatory paths for diabetes prevention and for modification of diabetes disease progression. Expected Impact Project is expected to discover and validate human phenotypes and biomarker panels for patient segmentation/selection, clinical trial design and regulatory paths to assess new therapeutic options for prevention of type 2 diabetes as well as slowing down the progression of the disease.In addition new regulatory approaches or standards enabling innovative and feasible clinical trial designs for disease modification in patients with prediabetes or type 2 diabetes will be developed. As well as benefit/risk models for public health and economic impact of those interventions. Budget IMI contribution: EUR 8 130 000EFPIA contribution: EUR 8 130 000Total: EUR 16 260 000
