Youth with Type 2 Diabetes get better results with two-drug treatment

by Bruce Sylvester – Combination metformin and rosiglitazone is more effective than metformin monotherapy in youth with recent-onset type 2 diabetes, researchers from The Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) study reported.

Today the first major comparative effectiveness trial for the treatment of type 2 diabetes in young people, and it was funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of National Institutes of Health (NIH). The findings appeared in the New England Journal of Medicine on April 29, 2012.

The investigators also reported that metformin therapy alone was not an effective treatment for many subjects, and it had a much higher failure rate than in studies of adults treated with metformin monotherapy.

“The results of this study tell us it might be good to start with a more aggressive drug treatment approach in youth with type 2  diabetes,” said Philip Zeitler, M.D., Ph.D., the TODAY study chair and a pediatric endocrinologist at Children’s Hospital Colorado, Aurora. “We are learning that type 2 diabetes is a more aggressive disease in youth than in adults and progresses more rapidly, which could be why metformin alone had a higher than expected failure rate.”

The TODAY study enrolled 699 subjects ages 10 to 17 with type 2 diabetes for less than two years and a body mass index (BMI) at the 85th percentile or greater. Overweight children have a BMI at the 85th to 94th percentile for their age and sex, while obesity is defined as a BMI at the 95th percentile or more. The TODAY participants had an average BMI at the 98th percentile.

Subjects were randomized to one of three treatment groups: metformin monotherapy, metformin and rosiglitazone combination, and metformin plus intensive lifestyle changes designed to enable weight loss and increased physical activity.

The investigators reported that treatment with metformin monotherapy was inadequate to maintain acceptable, long-term, blood glucose control in 51.7 percent of youth over an average follow-up of 46 months. Failure was 38.6 percent in the metformin and rosiglitazone group. In the metformin plus lifestyle cohort, failure was 46.6 percent.

Currently, metformin is the standard treatment for youths with type 2 diabetes. It is the only oral drug approved for such use by the U.S. Food and Drug Administration/FDA.