The results of a randomized clinical trial funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) in children with type 2 diabetes show that children and adolescents treated with a combination of metformin and Avandia (rosiglitazone) had better glycemic control than children treated with metformin alone or with metformin and with an intensive lifestyle-intervention program. The trial included 699 children with type 2 diabetes aged 10 -17 who were treated with metformin (at a dose of 1000 mg twice daily) to attain an HbA1c level of less than 8% and were randomly assigned to continued treatment with metformin alone or to metformin combined with rosiglitazone (4 mg twice a day) or a lifestyle-intervention program focusing on weight loss through eating and activity behaviors.
The primary results of the study show that metformin therapy (alone) provided durable glycemic control in only half the participants but the combination of metformin and Avandia improved the durability of glycemic control and metformin combined with lifestyle intervention was no better than metformin alone in maintaining glycemic control.
Whether the effect shown in this study is specific for Avandia, a more general effect of thiazolidinediones, or a feature of combination therapy is unclear. This question is of particular importance, given the currently restricted status of Avandia in the United States and Europe.
The results of the trial were published in The New England Journal of Medicine.
An addendum to my previous comment:
The following is a quote from the main author of the study on Avandia and metformin in children with Type 2 diabetes:
“Thiazolidinediones “made sense when we were designing the study in 2002,” Dr. Zeitler told Medscape Medical News. “Since then, it’s become clear that there are enough concerns about it that we’re not going to give this as a recommendation…. We see this as an argument for a need to consider intensification of therapy in these kids.”
So even the author of the study is not recommending rosiglitazone plus metformin as a treatment.
Now we know that rosiglitazone is associated with worsened cholesterol profiles and heart attacks in adults. We also know that changes in the blood vessels that lead to coronary artery disease occur early in life. Given the above it seems unconscionable to give this drug to children who will be at very high risk for cardiovascular disease and heart attacks during their lifetime. This is especially so in the light of the fact that there is a similar drug called pioglitazone that lowers blood sugar like rosiglitazone but doesn’t worsen LDL cholesterol level and doesn’t seem to increase risk of… Read more »