Maintenance of Glycemic Control in Type 2 Diabetes
Mary Perry Alexander
Takara Stanley
A Clinical Trial to Maintain Glycemic Control in Youth With Type 2 Diabetes TODAY (Type 2 Diabetes in Adolescents and Youth) Study Group
Zeitler P, Hirst K, Pyle L, et al. N Engl J Med. 2012;366(24):2247–2256
Background
In youth, along with a dramatic rise in obesity, the prevalence of type 2 diabetes mellitus (T2DM) has increased since the 1990s. Because organ-damaging vascular disease from hyperglycemia accrues over time, it is particularly important to achieve glycemic control in children, but there was previously little evidence to guide this.
Objectives
To evaluate whether combination therapy with metformin and rosiglitazone would provide improved glycemic control in youth with recent-onset T2DM as compared to metformin alone, or metformin + lifestyle modification.
Methods
Randomized clinical trial conducted at 15 US centers from 2004 to 2011.
Patients
699 patients ages 10 to 17 years with T2DM for <2 years, negative diabetes-related autoantibodies, and body mass index (BMI) ≥85th percentile. Select exclusion criteria: renal or hepatic impairment, steroid use, pregnancy.
Intervention
Comparison of 1,000 mg metformin twice daily with metformin + 4 mg rosiglitazone twice daily or metformin + intensive lifestyle intervention (weekly in-person contact with lifestyle coach for 6 months, 200 to 300 minutes of physical activity per week, 1,200 to 1,500 kcal/d diet). Mean follow-up was 3.8 years. Medication intervention was double blinded.
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