Restoring Insulin Secretion – Pediatric Medication Study (RISE Pediatric Medication)
Number of Subjects in Study Archive: 91
Study Design: Interventional
Conditions: Diabetes Mellitus, Type 2, Prediabetic State
Duration: June 2013 – April 2018
# Recruitment Centers: 4
Treatment: Metformin, Glargine
Available Genotype Data: No
Image Summary: No
Transplant Type: None
Does it have dialysis patients: No
Clinical Trials URL: https://clinicaltrials.gov/ct2/show/NCT01779375
Although type 2 diabetes is more common in adults, there has been an increase in the number of children with the disease, primarily due to the obesity epidemic. As with adults, the decline of beta-cell function and insulin sensitivity are precursors of type 2 diabetes in children. There are several treatments for adults with type 2 diabetes, however insulin and metformin are the only approved treatments for children with type 2 diabetes. The purpose of the Restoring Insulin Secretion (RISE) Pediatric Medication Study was to determine whether metformin or insulin combined with metformin could be used to sustain or improve beta-cell function in children with prediabetes or recently diagnosed type 2 diabetes.
The RISE Pediatric Medication Study was a two-arm, multi-center clinical trial. Study participants were enrolled at four recruitment centers and randomized into two treatment groups. The first group received metformin alone for 12 months. The second group received glargine, a man-made insulin, for three months followed by metformin for the remaining nine months of the treatment period. Beta-cell function and insulin sensitivity were assessed at baseline, the end of the active treatment period, and three months after treatment was withdrawn.
The RISE Pediatric Medication Study sought to determine if medicinal treatment could improve beta-cell function in adolescents with prediabetes or early type 2 diabetes, and whether the enhancements could be preserved after treatment was withdrawn.
Primary Outcome Measures:
Beta-cell function and insulin sensitivity were assessed three months after treatment withdrawal and compared to baseline measurements.
Secondary Outcome Measures:
At the end of the 12-month active treatment period, beta-cell function and insulin sensitivity were assessed and compared to baseline measurements.
Individuals were included in the study if they were age 10 – 19 years; had diabetes for less than six months; were treated with Metformin for less than six months prior to screening; pubertal development Tanner stage greater than one; and met the requirements for laboratory-based HbA1c and glucose (fasting and OGTT).
Individuals were excluded from study participation if they had an underlying disease, other than type 2 diabetes, that affects glucose metabolism; cardiovascular disease; anemia or known coagulopathy; renal disease or serum potassium abnormality; active infections; were treated with insulin for more than one week prior to screening; required or currently taking medications that affect glucose metabolism; had an underlying disease or condition that would increase the risk of intervention, limit life span, or limit participation in outcomes assessment; history of conditions that may be triggered or worsened by the study drug; or had conditions or behaviors that would interfere with study procedures.
Study results indicate beta-cell function in adolescents with prediabetes or early type 2 diabetes cannot be improved or maintained through treatment with metformin alone or glargine followed by metformin. Following 12 months of active treatment, participants in both groups experienced a decline in beta-cell function compared to baseline. Measurements taken after three months of treatment withdrawal also showed a deterioration of beta-cell function compared to baseline. Based on these results, it can be concluded that different approaches to prevent the loss of beta-cell function and improve insulin sensitivity are needed for individuals in this demographic.