RISE Pediatric Medication Study (RISE Peds)
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|ClinicalTrials.gov Identifier: NCT01779375|
Recruitment Status : Completed
First Posted : January 30, 2013
Results First Posted : October 8, 2018
Last Update Posted : October 10, 2018
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 16, 2013|
|Actual Primary Completion Date :||July 12, 2017|
|Actual Study Completion Date :||January 4, 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: Glucophage
Other Name: Insulin glargine, Lantus
- ß-cell Response Measured by Hyperglycemic Clamp [ Time Frame: 3-months after medication washout (Month 15) ]Clamp measures of ß-cell response, co-primary outcomes
- M/I [ Time Frame: 3-months after a medication washout ]Clamp measure of insulin sensitivity
- ACPRg [ Time Frame: 3-months after a medication washout ]First phase response
- ß-cell Function Measured by Hyperglycemic Clamp Techniques at M12 [ Time Frame: End of active intervention (Month 12). ]Participants had 12-months of active therapy. Secondary results at the end of active intervention.
- Clamp Measure of Insulin Sensitivity [ Time Frame: End of active intervention (Month 12) ]Participants had 12-months of active therapy. Secondary results at the end of active intervention.
- OGTT Measures of ß-cell Function and Glucose Tolerance [ Time Frame: After 12 months of active treatment, and 3 and 9 months of washout ]Measures derived the OGTT at the end of the 12 month active intervention period, and following a 3-month and 9-month washout.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|