RISE Pediatric Medication Study – Phase III

The Restoring Insulin Secretion Study: RISE Pediatric Medication Study

Protocol Description

Through the multicenter RISE Pediatric Medication Study, investigators hope to learn whether treatments used for diabetes can slow the change from prediabetes to diabetes, or slow the progression of diabetes in youth recently diagnosed with type 2 diabetes or prediabetes. Researchers currently believe that the best time to slow or prevent diabetes is in its earliest stages. While the primary goal is to determine if aggressive insulin therapy can lead to sustained recovery of beta-cell function, researchers will also assess durability of glucose tolerance following withdrawal of therapy and whether biomarkers can predict parameters of beta-cell function, insulin sensitivity, and glucose tolerance, and the response to an intervention.

Study Level: Phase III

Eligibility Criteria

Subject to certain exclusion criteria, the study is accepting children of both genders, ages 10 through 19, who have been diagnosed with early type-2 diabetes or prediabetes.
Males and Females: Ages 10-19


The study has 2 parts: a screening phase and a treatment phase. Screening includes an examination, an oral glucose tolerance test and a medication “run-in” period. Those who pass the screening phase will be randomized into one of the following treatment regimens: either oral metformin alone for 12 months or injections of insulin glargine for 3 months followed by metformin for up to 9 months.
Visits: 11
Duration: Up to 21 months

Status: Closed to Enrollment

Source(s) of Support

National Institute of Diabetes and Digestive and Kidney Diseases
National Institutes of Health

Primary Investigator

Silva A. Arslanian, MD

Contact Information

For more information about the study, please contact:
RISE Study Coordinator Nancy Guerra, CRNP