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.