Type 2 Diabetes in Kids a Challenge to Control
Study Shows Early Aggressive Combo Treatment May Result in Better Blood Sugar Control
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Avandia Use Restricted During Trial continued...
The finding that adding Avandia to metformin resulted in better outcomes raises more questions than it answers, since Avandia is no longer a treatment option for children and teens, says University of Wisconsin professor of pediatrics David B. Allen, MD.
In September of 2010, while the trial was under way, the FDA placed broad restrictions on Avandia's use following reports of heart attacks and strokes in adults taking the drug.
Participants in the Avandia part of the study continued taking the drug following a safety review, and no serious side effects were reported.
Lifestyle Findings Disappointing
The study, published early in the New England Journal of Medicine, included 699 patients between the ages of 10 and 17 who were diagnosed with type 2 diabetes about eight months before recruitment into the study.
Study participants were randomly split into three treatment groups: treatment with metformin alone, metformin and Avandia together, or metformin plus lifestyle changes designed to promote weight loss.
Over an average follow-up of nearly four years:
- About half the patients who took metformin alone failed the treatment, meaning that they did not achieve adequate blood sugar control for a minimum of two years or ended up requiring insulin.
- 38% of patients who took metformin and Avandia failed treatment.
- 46% of patients in the metformin and lifestyle part of the study failed treatment. A family-based weight management program was found to add little benefit to treatment with metformin alone. While some children in the program lost weight, most did not.
Those taking part in the lifestyle program tended to lose more weight than the other children, but the weight loss did not translate to better blood sugar control.
"We are still trying to understand this, but the findings should not be interpreted as suggesting that lifestyle doesn't matter," Linder says.
In an editorial published along with the study, Allen argues that efforts to teach children to make healthy lifestyle choices are undermined by the environment they live in.
"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," he writes. "Until a healthier 'eat less, move more' environment is created for today's children, lifestyle interventions like that in (this) study will fail."