Milken Institute SPH’s Biostatistics Center served as coordinating center for NIH-funded study.
Two diabetes medications don’t slow progression of Type 2 diabetes in youth
Only two drugs are currently approved for youth with Type 2 diabetes: glargine, a long-acting insulin, and metformin, an anti-diabetic medication. A new study finds neither effectively slows progression of the disease in youth. The study’s results were concurrently published online June 25 in Diabetes Care and presented at the American Diabetes Association Scientific Sessions in Orlando, Florida.
The results come from a study of 91 youth between the ages of 10 and 19 and is part of a larger study called Restoring Insulin Secretion, or RISE. To determine if early, aggressive treatment would improve outcomes, youth were randomly assigned to one of two treatment groups. The first group received three months of glargine followed by nine months of metformin. The second group received only metformin for one year. Participants were monitored for three months after treatment ended.
Beta cell function, the key to the body’s ability to make and release insulin, declined in both groups during treatment and worsened after treatment ended. Previous research found that Type 2 diabetes progresses quicker in youth than previously reported in adults despite comparable treatment.
RISE was funded primarily by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health and conducted at eight study sites. The Biostatistics Center based at Milken Institute School of Public Health at the George Washington University served as the coordinating center for the study. In this role, the Biostatistics Center managed numerous aspects of the study.
According to Sharon Edelstein, ScM, Lead Research Scientist and Principal Investigator of the coordinating center for RISE, the Biostatistics Center collaborated with the clinical center investigators on the study design; developed the operation manuals; designed and implemented all data collection forms, data entry and systems; and performed data analysis for the study.
“This data, along with future findings from RISE, is crucial for us to figure out why Type 2 diabetes in youth progresses quicker than in adults and how we can stop it,” Edelstein said.
The longer a person has Type 2 diabetes, the greater the likelihood of developing complications including heart, kidney, eye, and nerve diseases. As a result, it’s critical for youth with Type 2 diabetes to achieve and sustain control of their blood glucose. However, Type 2 diabetes has historically been an adult condition, so information about how to effectively treat youth is limited, and pediatric diabetes experts currently rely on best practices for adult treatment.
“Type 2 diabetes in youth has grown with the obesity epidemic, and we need treatments that work for kids,” said Ellen Leschek, project scientist for the RISE Consortium and program director in NIDDK’s Division of Diabetes, Endocrinology, and Metabolic Diseases. “It’s clear from this study and others that type 2 diabetes in youth is more aggressive than in adults.”
NIH support for RISE comes primarily through NIDDK grants U01DK94430, U01DK94431, U01DK94406, U01DK94438 and U01DK094467, with additional support from the National Center for Advancing Translational Sciences. The Department of Veterans Affairs, Kaiser Permanente Southern California, and the American Diabetes Association also support the studies, with additional donations of supplies from Allergan Corporation, Apollo Endosurgery, Abbott Laboratories, and Novo Nordisk A/S.