U.S. Department of Health and Human Services

Trial Highlights Challenge in Treating Youth with Type 2 Diabetes

Results reveal that type 2 diabetes is more difficult to treat in youth with the disease than in adults. Although type 2 diabetes is most commonly diagnosed in people over the age of 40, an increase in childhood obesity and other factors has led to a significant rise in cases in people under 20 years of age. Since development of long term complications in adults is related to both duration of diabetes and control of blood glucose levels, the increasing prevalence of people diagnosed with type 2 diabetes during childhood is a major public health concern. Prior to this study, it was unknown whether treatments developed for adults would work well for younger patients. Metformin, the first-line drug of choice among adults with type 2 diabetes, is currently the only oral medication approved for use in children. 

The Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) trial tested how well three treatment approaches controlled blood glucose levels in youth ages 10 to 17. At the start of the study, the 699 participants had type 2 diabetes for less than 2 years and were either overweight or obese (as measured by a body mass index at the 85th percentile or greater). Participants were randomly assigned to receive either metformin alone; metformin and another diabetes drug, rosiglitazone, together; or metformin plus intensive lifestyle changes aimed at helping participants lose weight and increase physical activity. Unfortunately, metformin alone failed to maintain acceptable, long-term blood glucose control in 51.7 percent of youth over an average follow up of 46 months—a much higher failure rate than expected. Metformin plus lifestyle changes failed 46.6 percent of the time, an improvement over metformin alone that is not statistically significant. The combination of metformin plus rosiglitazone was significantly better, but still failed 38.6 percent of the time over the follow-up period. Importantly, after the study began, the U.S. Food and Drug Administration restricted use of rosiglitazone because of studies linking the medicine to a higher risk of heart attacks and stroke in adults. Thus, at this point, rosiglitazone is not recommended for use in children. 
 
These results suggest treatment with metformin alone may be inadequate for a majority of youth with type 2 diabetes, and that type 2 diabetes is a more aggressive disease in youth than in adults. The findings also emphasize the importance of preventing and treating childhood obesity, so that overweight and obese youth do not develop type 2 diabetes. Most of the medications widely used by adults to control type 2 diabetes have not been studied in children. Additional research is needed to determine whether any of these, singly or in combination, can safely and reliably control blood glucose in young people with the disease. 

Zeitler P, Hirst K, Pyle L, et al. A clinical trial to maintain glycemic control in youth with type 2 diabetes. N Engl J Med 366: 2247-2256, 2012.