RISE Pediatric Medication Study (RISE Peds)
|ClinicalTrials.gov Identifier: NCT01779375|
Recruitment Status : Active, not recruiting
First Posted : January 30, 2013
Last Update Posted : September 28, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Prediabetes Type 2 Diabetes||Drug: Metformin Drug: Glargine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||91 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Restoring Insulin Secretion Pediatric Medication Study|
|Actual Study Start Date :||June 2013|
|Primary Completion Date :||July 2017|
|Estimated Study Completion Date :||January 2018|
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
- 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): 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|