Youth with type 2 diabetes at risk for add-on therapies
Published: May 11, 2012
Youth diagnosed with type 2 diabetes may require a combination treatment or insulin therapy within a few years after diagnosis, according to a study published online April 29 in the New England Journal of Medicine.
The results are from the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) study led by Philip Zeitler, MD, PhD, section head of endocrinology at Children’s Hospital Colorado in Aurora and professor of pediatrics and clinical sciences at the University of Colorado School of Medicine in Denver.
Dr Zeitler and colleagues noted that there are few data to guide treatment despite the rising rate of youth diagnosed with type 2 diabetes. They designed the multicenter, randomized clinical trial to test the hypothesis that combination therapy initiated early would maintain acceptable glycemic control better than metformin alone.
The investigators randomly assigned 699 (75.4%) patients, aged 10 to 17 years, to receive metformin (at a dose of 1,000 mg twice daily) alone, metformin plus rosiglitazone (4 mg twice daily), or metformin plus a lifestyle-intervention program, which focused on weight loss through family-based changes in eating and behavior. Patients were followed for an average of 3.86 years for a primary outcome of loss of glycemic control.
Of the 699 participants, 319 (45.6%) reached the primary outcome, with a median time to treatment failure of 11.5 months. The investigators noted that 51.7% of patients treated with metformin monotherapy had treatment failure—a rate higher than that observed in recently diagnosed adult patients. In addition, they noted that metformin combined with lifestyle intervention was no better than metformin alone in maintaining glycemic control with 46.6% of patients experiencing treatment failure. The combination of metformin and rosiglitazone improved the durability of glycemic control, but 38.6% still had treatment failure.
“Further analysis is required to determine whether the apparent decrease in the durability of glycemic control with metformin in adolescents as compared with adults reflects biologic differences, pathophysiological differences, or both,” the authors wrote. “Further analysis of the effect of various components of the lifestyle intervention is needed to understand the current findings and identify ways to effectively integrate behavioral self-management in the ongoing care of youth with type 2 diabetes,” they added.
In an editorial that accompanied the study, David B. Allen, MD, from the Department of Pediatrics, University of Wisconsin School of Medicine and Public Health, Madison, noted that the issue is a societal and cultural problem that needs to be resolved through public policy, not medication.
“A critical point is that the participants in the TODAY study were not adults, but youth immersed from a young age in a sedentary, calorie-laden environment that may well have induced and now aggravates their type 2 diabetes. Fifty years ago, children did not avoid obesity by making healthy choices; they simply lived in an environment that provided fewer calories and included more physical activity for all. Until a healthier “eat less, move more” environment is created for today’s children, lifestyle interventions like that in the TODAY study will fail,” Dr Allen wrote.
The study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases.