Investigators compared the efficacy of 3 treatment regimens in 699 youngsters aged from 10 to 17 years with type 2 diabetes: metformin monotherapy (1,000 mg twice daily), metformin plus rosiglitazone (4 mg twice daily), or metformin plus a lifestyle-intervention program focused on weight loss through family-based changes in eating and activitiy behaviors.
Investigators compared the efficacy of 3 treatment regimens in 699 youngsters aged from 10 to 17 years with type 2 diabetes: metformin monotherapy (1,000 mg twice daily), metformin plus rosiglitazone (4 mg twice daily), or metformin plus a lifestyle-intervention program focused on weight loss through family-based changes in eating and activity behaviors.
Participants who had diagnosed type 2 diabetes for a mean duration of 7.8 months and a body mass index (BMI) more than or equal to the 85th percentile for age and sex were followed for an average of nearly 4 years.
Of the total number of patients, 319 (45.6%) experienced treatment failure (defined as a persistently elevated glycated hemoglobin level [≥8%] over a period of 6 months or persistent metabolic decompensation) within a median time of 11.5 months.
Body mass index over time differed significantly according to the study treatment, with the metformin-plus-rosiglitazone group having the greatest BMI increase and the metformin-plus-lifestyle group the least. Nonetheless, neither BMI at baseline nor over time was a determinant of treatment failure.
Race or ethnic group had a significant effect on outcome, regardless of treatment group. The overall failure rate among non-Hispanic blacks, Hispanics, and non-Hispanic whites was 52.8%, 45%, and 36.6%, respectively. Metformin alone was less effective in non-Hispanic blacks, and metformin plus rosiglitazone most effective in girls. Serious adverse events were reported by 19.2% of participants (TODAY Study Group. N Engl J Med. 2012. Epub ahead of print).
Type 2 diabetes mellitus was once a rarity in pediatrics. Now, nearly half of new cases of diabetes diagnosed in adolescents is type 2 disease (J Pediatr. 2005;146:693-700). And in a few years, as the generation of children afflicted by the epidemic of obesity reaches adolescence, this condition may be even more common, becoming a disease managed by general pediatricians rather than endocrinology consultants. We need to be aware of advances in treatment of this condition while continuing our multidimensional efforts to tip the scales against the development of obesity in our patients. -Michael Burke, MD