The RISE Pediatric Medication Study is a 2-arm, 4-center, clinical trial of children 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. Pediatric participants (ages 10-19) will be randomized to one of the following
treatment regimens: (1) metformin alone or (2) early intensive treatment with basal insulin
glargine followed by 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.
Phase:
Phase 3
Details
Lead Sponsor:
RISE Study Group
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)