Dataset from Studies to Treat Or Prevent Pediatric Type 2 Diabetes (STOPP-T2D) Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) Clinical Trial

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National
Institutes of Health (NIH) has sponsored a consortium of investigators to conduct a clinical
treatment trial, Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY).

The primary objective of the TODAY trial is to compare the efficacy of three treatment arms
on time to treatment failure based on glycemic control. The secondary aims are to:

- compare and evaluate the safety of the three treatment arms;

- compare the effects of the three treatments on the pathophysiology of type 2 diabetes
(T2D) with regards to beta cell function and insulin resistance, body composition,
nutrition, physical activity and aerobic fitness, cardiovascular risk factors,
microvascular complications, quality of life, and psychological outcomes;

- evaluate the influence of individual and family behaviors on treatment response; and

- compare the relative cost effectiveness of the three treatment arms.

The three treatment regimens are: (1) metformin alone, (2) metformin plus rosiglitazone, and
(3) metformin plus an intensive lifestyle intervention called the TODAY Lifestyle Program
(TLP). The study recruits patients over a three-year period and follows patients for a
minimum of two years. Patients are randomized within two years of the diagnosis of T2D.