Two drugs may be better than one for treating children and teens who have type 2 diabetes, a new study suggests.
The new federally funded study, published in the New England Journal of Medicine on Sunday, found that a combination of two diabetes drugs, metformin and rosiglitazone, is more effective than metformin alone or metformin plus lifestyle intervention for maintaining blood sugar control in children with the disease.
However, researchers noted that the combination of metformin and rosiglitazone failed to help more than a third of participants who took it.
The study included 699 participants aged 10 to 17 with type 2 diabetes for less than two years. Researchers evaluated how well and for how long each of the three treatment approaches, metformin alone, metformin and rosiglitazone together, and metformin plus intensive lifestyle changes designed to help participants lose weight and increase physical activity, controlled participant’s blood glucose levels.
The findings show that the overall rates of failure for metformin alone was inadequate for maintaining acceptable, long-term, blood glucose control in 51.7 per cent of participants over an average follow-up period of 46 months. Metformin and rosiglitazone failed to help 38.6 percent of the participants in the combination group and the failure rate for metformin plus lifestyle group was at 46.6 percent.
The findings show that 19.2 percent of all participants reported serious adverse events, with 18.1 percent of participants in the metformin-alone group, 14.6 percent in the metformin-plus-rosiglitazone group, and 24.8 percent in the metformin-plus-lifestyle group reporting side effects.
Researchers noted that of the 227 participants who reported adverse events, 87 percent or 134 of the cases were not considered to be related to the study treatment, and hospitalizations accounted for more than 90 percent of all serious adverse events.
Metformin is currently the standard treatment for young type 2 diabetes patients, and the only U.S. Food and Drug Administration-approved drug for treating young people with this condition.
Experts say that the childhood obesity epidemic has created a new wave of children and teens with type 2 diabetes, which has traditionally been a disease that primarily affected adults, and treatment decisions for children have been based on what is known about adults with type 2 diabetes.
The latest findings suggest that aggressive and early drug therapy may help young people with type 2 diabetes to regulate their blood sugar levels and reduce the risk of developing complications such as heart disease, stroke, kidney and eye disease, and nerve damage.
"This important study provides much-needed information about how to treat type 2 diabetes in young people. Earlier studies in adults have shown that early, effective treatment can prevent serious and costly diabetes complications later in life," said National Institute of Diabetes and Digestive and Kidney Diseases Director Dr. Griffin Rodgers, in a statement.
Researchers also stressed that the current standard treatment with metformin alone is not sufficient in treatment kids with type 2 diabetes.
"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," pediatric endocrinologist and researcher Dr. Philip Zeitler at the Children's Hospital Colorado said in a statement. "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 FDA had placed broad restrictions on rosiglitazone in 2010 because previous studies linked the drug to a higher risk of heart attacks and stroke in adults, but researchers said that participants in the latest study did not report any serious side effects from using rosiglitazone.