May 7, 2012
Treating Type 2 Diabetes in YouthA combination of 2 diabetes drugs, metformin and rosiglitazone, was more effective in treating youth with type 2 diabetes than metformin alone, according to a new study.
Several drugs are available to treat adults with type 2 diabetes. But only one oral medication—metformin—is approved by the U.S. Food and Drug Administration for treating young people with type 2 diabetes. The Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) study set out to test additional approaches to controlling blood glucose levels in youth. The study was funded primarily by NIH's National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
The researchers enrolled 699 youth, ages 10 to 17, who had type 2 diabetes for less than 2 years. All participants were considered overweight or obese. On average, their body mass index (BMI) was at the 98th percentile. The 85th percentile is considered overweight; 95th percentile is considered obese. The youth were randomly assigned to 3 treatment groups: metformin alone, metformin plus rosiglitazone (sold as Avandamet), and metformin plus intensive lifestyle changes aimed at weight loss and increased physical activity. Results appeared on April 29, 2012, in the early online edition of the New England Journal of Medicine.
The researchers were surprised to find that, over an average follow-up of 46 months, metformin alone maintained acceptable, long-term blood glucose control in only about half the youth. Also unexpected was the failure rate in the metformin plus lifestyle group, which was little better than metformin alone. In contrast, the failure rate was under 39% in the metformin and rosiglitazone group, a 25% reduction from metformin alone.
The use of rosiglitazone in adults has been restricted because studies linked its use in adults to a higher risk of heart attack and stroke. After a careful examination of the safety data, the TODAY Data and Safety Monitoring Board recommended that the study continue to test rosiglitazone. There were no cardiac events such as heart attack during the study.
“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,” says TODAY study chair Dr. Philip Zeitler of 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.”
Further study will be needed to see if more aggressive therapy will yield long-term benefits for youth with type 2 diabetes as they move into adulthood. Another question is why the rigorous lifestyle intervention didn’t bring the benefits that similar strategies have produced in adults. More research will be needed to design approaches that produce effective lifestyle changes for young people with type 2 diabetes.
- National Diabetes Education Program:
- Diabetes Prevention A Good Investment: