RISE 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.
Type 2 Diabetes
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Restoring Insulin Secretion Adult Medication Study|
- ß-cell function measured by hyperglycemic clamp techniques [ Time Frame: 3-months after a medication washout ] [ Designated as safety issue: No ]Participants will have 12-months of active therapy and 3-months of washout after which the primary outcome will be assessed.
- Hyperglycemic clamp and oral glucose tolerance test (OGTT) measures of ß-cell function and glucose tolerance [ Time Frame: 3-months after a medication washout ] [ Designated as safety issue: No ]Measures derived from the hyperglycemic clamp that are not specified as primary outcomes and measures derived from the OGTT.
- Hyperglycemic clamp and OGTT measures of ß-cell Function and Glucose Tolerance [ Time Frame: After 12 months of active treatment ] [ Designated as safety issue: No ]Measures derived from the hyperglycemic clamp and the OGTT related to treatment effect at the end of the 12 month active intervention period compared to pre-treatment baseline.
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||August 2017|
|Estimated Primary Completion Date:||August 2017 (Final data collection date for primary outcome measure)|
Active Comparator: Metformin alone
Metformin will be titrated to the maximum dose tolerated (up to 2000 mg/day). Participants randomized to the metformin-alone arm will be blinded to treatment.
Other Name: Glucophage
Active Comparator: Glargine followed by Metformin
Basal insulin glargine for 3 months titrated to achieve a morning fasting blood glucose of 80-90 mg/dl, followed by open-label metformin (titrated up to 2000 mg/day) for 9 months.
Other Name: GlucophageDrug: Glargine
Other Name: Insulin glargine, Lantus
Placebo Comparator: Placebo
Placebo - masked to metformin-alone. Placebo will be titrated to the maximum number of tablets equivalent to maximum dose of metformin.
Active Comparator: Liraglutide + Metformin
Liraglutide + open-label Metformin. Liraglutide will be titrated to the maximum dose tolerated (up to 1.8 mg/day) after which metformin will be titrated to the maximum dose tolerated (up to 2000 mg/day).
Other Name: GlucophageDrug: Liraglutide
Other Name: Victoza
|United States, Illinois|
|University of Chicago||Recruiting|
|Chicago, Illinois, United States, 60637|
|Contact: Abby Rue 773-702-4295 firstname.lastname@example.org|
|Principal Investigator: David Ehrmann, MD|
|United States, Indiana|
|Indianapolis, Indiana, United States, 46202|
|Contact: Robin Chisholm, RN 317-274-7679 email@example.com|
|Principal Investigator: Kieren Mather, MD|
|United States, Washington|
|VA Puget Sound Health Care System||Recruiting|
|Seattle, Washington, United States, 98108|
|Contact: Brenda Mongtomery, RN, MS 206-768-5215 firstname.lastname@example.org|
|Principal Investigator: Steven Kahn, MB, ChB|