PHILADELPHIA, PA--(Marketwire - June 9, 2012) - Children diagnosed with type 2 diabetes appear to experience a more rapidly progressive disease than people who are diagnosed as adults, with a higher rate of early complications and a relatively early need for combination therapy or insulin, according to research results from the largest, and only, longitudinal study of its kind to date, of children with diabetes, presented at the American Diabetes Association's 72nd Scientific Sessions®.
The Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) study, which was designed to test the efficacy and safety of diabetes medications for young people, was also able to identify which group of children would be able to manage their diabetes and which would face more rapid progression of the disease based on their initial response to metformin treatment. Researchers found that those who had good glycemic control (as evidenced by A1C levels in the normal range) after two to four months on metformin during the pre-randomization period were more likely to maintain that control for at least 48 months than those whose A1C levels were greater than 6.1 percent after the first few months of treatment on metformin.
"The good news is nearly 50 percent of the kids did well on metformin therapy," said Phil Zeitler, MD, PhD, TODAY study Chair and Professor of Pediatrics at the University of Colorado. "For the other 50 percent, we need to focus on what type of treatment is best for them and at this point, the only well-studied option is combination with insulin."
The study was designed to also test the efficacy and safety of rosiglitazone as a treatment for youth with type 2 diabetes, finding that combining metformin with rosiglitazone reduced the need to transition young patients to insulin therapy by 25 percent. However, because use of this drug has since been limited by the U.S. Food and Drug Administration due to safety concerns, researchers said they could not recommend its use in children. Initial results from the TODAY study, showing that nearly 50 percent of youth with type 2 diabetes needed insulin therapy within a few years of diagnosis, were released at the end of April.
"Despite our positive findings that combining metformin with rosiglitazone helped more of these kids to maintain glycemic control, and the fact that we had no safety issues with the patients in our study, we cannot recommend that youth use this therapy because rosiglitizone is essentially off the market today," said Investigator Lori Laffel, MD, MPH, Chief of the Pediatric, Adolescent and Young Adult Section at the Joslin Diabetes Center in Boston. "We can clearly say this disease is different in kids and we need to be more aggressive about beginning multiple therapies to preserve beta cell function and to prevent deterioration of A1C and blood glucose levels."
What those therapies should be, however, must be the focus of future investigations.
The TODAY study results emphasize the critical need for new treatments for youth by revealing the high rate of co-morbidities that manifest within a relatively short duration of living with the disease. Nearly one-third of the children in the study exhibited high blood pressure by the end of the study's mean follow-up of just under four years (compared to just 12 percent at the beginning of the study); and close to 17 percent exhibited elevated urinary albumin levels, an early marker of kidney disease (up from six percent at the beginning of the study). Roughly 13 percent of those in the study exhibited signs of eye disease, "which is relatively high after such a short duration of disease," Laffel said.
"The biggest concern with diabetes is the consequences in terms of cardiovascular disease and microvascular disease and these kids are at very high risk at young ages," Zeitler said. "Within the next 10-20 years, many of these kids will have substantial health problems. This suggests a major health burden in the future."
The TODAY study looked at 699 youth with type 2 diabetes at 15 health centers across the U.S., with a follow-up period of two to six years. Patients were between 10 and 17 years old when entered into the study and had been diagnosed within the past two years. They were separated into three treatment arms: one treated with metformin only; one with metformin plus rosiglitazone; and one with metformin plus intensive lifestyle changes. There was no difference in results between the metformin-only group and those who also received an intensive lifestyle change program.
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The American Diabetes Association is leading the fight to Stop Diabetes and its deadly consequences and fighting for those affected by diabetes. The Association funds research to prevent, cure and manage diabetes; delivers services to hundreds of communities; provides objective and credible information; and gives voice to those denied their rights because of diabetes. Founded in 1940, our mission is to prevent and cure diabetes and to improve the lives of all people affected by diabetes. For more information please call the American Diabetes Association at 1-800-DIABETES (1-800-342-2383) or visit www.diabetes.org. Information from both these sources is available in English and Spanish.