|
Study Objectives and Treatment Groups
|
|
TODAYs primary objective is to compare the efficacy of three
treatment arms on time to treatment failure based on glycemic
control. Treatment failure is defined as:
- HbA1c >8% over a six-month period
- inability to wean from temporary insulin therapy due to
metabolic decompensation.
Secondary aims are to:
- compare and evaluate the safety and cost-effectiveness
of the three treatment groups
- compare the treatments effects on the pathophysiology
of type 2 diabetes
- evaluate the influence of individual and family behaviors
on treatment response
The three treatment groups are:
- Metformin (500-1000 mg bid)
- Metformin (500-1000 mg bid) plus rosiglitazone (4 mg bid)
- Metformin plus an intensive lifestyle intervention called
the TODAY Lifestyle Program (TLP).
This program is designed to promote healthy, moderate weight loss
hrough changes in diet and increases in physical activity.
|
|