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Restoring Insulin Secretion Adult Medication Study (RISE Adult)
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.
Details
| Lead sponsor | RISE Study Group |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 267 |
| Start date | 2013-04 |
| Completion | 2019-08 |
Conditions
- Prediabetes
- Type 2 Diabetes
Interventions
- Metformin
- Liraglutide
- Glargine
- Placebo
Primary outcomes
- ß-cell Response Measured by Hyperglycemic Clamp — 3-months after medication washout (Month 15)
Clamp measures of ß-cell response, co-primary outcomes - Insulin Sensitivity, M/I — 3-months after a medication washout
Clamp measure of insulin sensitivity
Countries
United States