Study Design
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 (NIDDK) (members of the study
group are listed in Section A in the Supplementary
Appendix, available with the full text of this
article at NEJM.org). The TODAY study compared
metformin monotherapy with two alternative approaches,
one combining metformin with a second
pharmacologic agent (rosiglitazone) and one
combining metformin with an intensive lifestyleintervention
program, to test the hypothesis that
combination therapy initiated early in the course
of youth-onset type 2 diabetes would maintain
acceptable glycemic control better than metformin
alone.