RISE Pediatric Medication Study (RISE Peds)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Restoring Insulin Secretion Pediatric 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:||January 2018|
|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).
Other Name: Glucophage
Active Comparator: Glargine followed by Metformin
Basal insulin glargine for 3 months titrated to achieve a morning fasting blood glucose of 85-95 mg/dl, followed by metformin (titrated up to 2000 mg/day) for 9 months.
Other Name: GlucophageDrug: Glargine
Other Name: Insulin glargine, Lantus
Please refer to this study by its ClinicalTrials.gov identifier: NCT01779375
|United States, Colorado|
|Childrens Hospital Colorado|
|Denver, Colorado, United States, 80045|
|United States, Connecticut|
|Yale School of Medicine Pediatric Obesity and Type 2 Diabetes Clinic|
|New Haven, Connecticut, United States, 06511|
|United States, Indiana|
|Indianapolis, Indiana, United States, 46202|
|United States, Pennsylvania|
|Children's Hospital of Pittsburgh of UPMC|
|Pittsburgh, Pennsylvania, United States, 15224|