Abstract
TODAY Study Group: A clinical trial to maintain glycemic control in youth with type 2 diabetes. N Engl J Med 366:2247–2256, 2012 Objective. Prompt identification and intensification of glycemic control for adolescents with type 2 diabetes will lower their glycemic burden, establish metabolic memory, and reduce their risk of developing long-term complications as adults.1–3 This study evaluated the safety, efficacy, and durability of three different treatment protocols (metformin monotherapy, metformin plus rosiglitazone, and metformin plus lifestyle intervention) for young patients with type 2 diabetes who were randomized soon after being diagnosed. The primary objective of the study was to determine whether combination therapy initiated soon after diagnosis would maintain glycemic control better than metformin monotherapy. Design and methods. The Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) study was a multicenter, randomized clinical trial funded by the National Institute of Diabetes and Digestive and Kidney Diseases. The study's 699 patients with type 2 diabetes, aged 10–17 years, were initially treated with metformin, 1,000 mg twice daily (or 500 mg twice daily if 1,000 mg twice daily was not tolerated) until achieving an A1C ≤ 8% for a minimum of 2 months. Randomized patients' adherence was documented by pill count and study visit attendance for 6 weeks. The mean duration of type 2 diabetes in these patients was 7.8 months. Subjects were subsequently randomized to one of three treatment groups: 1 ) continuation of metformin as monotherapy; 2 ) metformin in combination with rosiglitazone, 4 mg twice daily; or 3 ) metformin plus lifestyle intervention targeting weight reduction and increased physical activity. The lifestyle program was designed to augment the pharmacological intervention by promoting moderate weight loss (7–10% of initial body weight or the equivalent for youth still growing in height). Primary behavior-change targets included energy balance behaviors …
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