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Member Research & Reports

Member Research & Reports

GW Biostatistics Center Serves as Coordinating Center for Landmark Diabetes Study

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 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. The study 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 George Washington University (GW) Milken Institute School of Public Health (Milken Institute SPH) served as the coordinating center for the study. In this role, the Biostatistics Center managed numerous aspects of the study.

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, said Ms. Sharon Edelstein, lead research scientist and principal investigator of the coordinating center for 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. The longer a person has Type 2 diabetes, the greater the likelihood of developing complications including heart, kidney, eye, and nerve diseases. 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.