RISE Adult Medication Study (RISE Adult)
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|ClinicalTrials.gov Identifier: NCT01779362|
Recruitment Status : Recruiting
First Posted : January 30, 2013
Last Update Posted : April 5, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Prediabetes Type 2 Diabetes||Drug: Metformin Drug: Liraglutide Drug: Glargine Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||255 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Restoring Insulin Secretion Adult Medication Study|
|Study Start Date :||April 2013|
|Estimated Primary Completion Date :||November 2017|
|Estimated Study Completion Date :||March 2019|
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.
Titrated to 1000 mg BID
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.
Titrated to 1000 mg BID
Other Name: GlucophageDrug: Glargine
Titrated to target fasting glucose <90 mg/dl
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.
Matching to metformin 1000 mg BI
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).
Titrated to 1000 mg BID
Other Name: GlucophageDrug: Liraglutide
Titrated to 1.8 mg/day
Other Name: Victoza
- ß-cell function measured by hyperglycemic clamp techniques [ Time Frame: 3-months after a medication washout ]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 ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01779362
|United States, Illinois|
|Jesse Brown VA Medical Center||Recruiting|
|Chicago, Illinois, United States, 60612|
|Contact: Bharathi Reddivari 312-569-6468 email@example.com|
|Contact: Arfana Akbar 312-569-6430 firstname.lastname@example.org|
|Principal Investigator: Elena Barengolts, MD|
|University of Chicago||Recruiting|
|Chicago, Illinois, United States, 60637|
|Contact: Abby Rue 773-702-4295 email@example.com|
|Principal Investigator: David Ehrmann, MD|
|United States, Indiana|
|Indianapolis, Indiana, United States, 46202|
|Contact: Tammy Garrett, RN 317-274-7679 firstname.lastname@example.org|
|Principal Investigator: Kieren Mather, MD|
|United States, Washington|
|VA Puget Sound Health Care System||Recruiting|
|Seattle, Washington, United States, 98108|
|Contact: Karen Atkinson, RN 206-764-2788 email@example.com|
|Principal Investigator: Steven Kahn, MB, ChB|