At a glance
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Restoring Insulin Secretion Adult Medication Study
In Brief
A Phase 3 clinical trial evaluating Metformin, Liraglutide, and 2 other interventions for Prediabetes and Type 2 Diabetes. Completed, enrolled 267 participants across 4 sites.
Detailed Summary
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.
Study Details
Timeline
Interventions
Titrated to 1000 mg BID
Titrated to 1.8 mg/day
Titrated to target fasting glucose \<90 mg/dl
Matching to metformin 1000 mg BI