RISE Pediatric Medication Study (RISE Peds)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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|
|Actual 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: Glucophage
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.
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|