Dataset from Restoring Insulin Secretion Adult Medication Study

The RISE Adult Medication Study is a 4-arm, 3-center, clinical trial of adults with
prediabetes and early type 2 diabetes to address the hypothesis that aggressive glucose
lowering will lead to recovery of beta-cell function that will be sustained after withdrawal
of treatment. Adult participants (ages 20-65) will be randomized to one of the following
treatment regimens: (1) blinded placebo, (2) blinded metformin alone, (3) early intensive
insulin treatment with basal insulin glargine followed by open-label metformin, (4) the
glucagon-like peptide-1 receptor agonist (GLP-1RA) liraglutide plus open-label metformin.

The primary clinical question RISE will address is: Are improvements in ß-cell function
following 12 months of active treatment maintained for 3 months following the withdrawal of
therapy? Secondary outcomes will assess durability of glucose tolerance following withdrawal
of therapy, and whether biomarkers obtained in the fasting state predict parameters of ß-cell
function, insulin sensitivity and glucose tolerance and the response to an intervention.