At a glance
ClinicalIndex Comparison Record- ✓Type 2 diabetes diagnosed by ADA criteria (fasting glucose ≥126 mg/dL, random glucose ≥200 mg/dL, or 2-hour OGTT ≥200 mg/dL; or elevated HbA1c ≥6% if normal fasting glucose but elevated 2-hour OGTT glucose).
- ✓Diagnosed within 2 years prior to randomization.
- ✓Age 10-17 years, must be randomized before 18th birthday.
- ✓BMI ≥85th percentile for age at time of diagnosis or screening.
- ✕Genetic syndrome or disorder affecting glucose tolerance other than type 2 diabetes.
- ✕Inhaled steroids >1000 mcg/day (Flovent equivalent).
- ✕Oral steroids within last 60 days or >20 days during past year.
- ✕Medications known to affect insulin sensitivity/secretion within last 30 days.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Studies to Treat Or Prevent Pediatric Type 2 Diabetes (STOPP-T2D) Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) Clinical Trial
In Brief
A Phase 3 clinical trial evaluating Metformin, Rosiglitazone, and 1 other intervention for Diabetes Mellitus, Type II. Completed, enrolled 699 participants across 16 sites.
Detailed Summary
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.
Study Details
Timeline
Interventions
capsule, 1000 mg bid
capsule, 4 mg bid
a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study