A clinical trial to maintain glycemic control in youth with type 2 diabetes


TODAY Study Group.
N Engl J Med. Epub ahead of print. 

This overview was created by KnowledgePoint360 Group, LLC, and was not associated with funding via an educational grant or a promotional interest. 

The Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) study was a multicenter, randomized clinical trial that examined whether rosiglitazone plus metformin or intensive lifestyle intervention plus metformin initiated early in the disease course of youth-onset type 2 diabetes would maintain acceptable glycemic control better than metformin monotherapy.  

Eligible subjects met the following criteria:  

  • Aged 10–17 years  
  • Type 2 diabetes per American Diabetes Association criteria for <2 years  
  • Body mass index ≥85th percentile for age and sex  
  • Negative test results for diabetes-related autoantibodies  
  • Fasting C-peptide >0.6 ng/ml  
  • Availability of adult caregiver willing to support study participation  

Eligible subjects entered 2–6 month run-in period with the following goals:  

  • Weaning subjects from nonstudy medications  
  • Initiating metformin therapy at dose of ≤1,000 mg bid but no less than 500 mg bid  
  • Attaining A1C <8.0% (measured monthly) with metformin alone  
  • Providing standard diabetes education and ensuring mastery of material  
  • Confirming adherence to study regimen scheduled visits  

Subjects received metformin (1,000 mg twice daily) to attain A1C goal <8% and were then randomized to:  

  • Continued metformin monotherapy (n=232)  
  • Rosiglitazone (4 mg twice daily) + metformin (n=233)  
  • Metformin + intensive lifestyle-intervention program (weight loss through changes in eating and activity behaviors; n=234)  

The study’s primary outcome was loss of glycemic control, defined as A1C ≥8% for 6 months or sustained metabolic decompensation requiring insulin therapy (defined as either the inability to wean the participant from insulin within 3 months after therapy initiation for decompensation or second episode of decompensation within 3 months after insulin discontinuation). In the first year, A1C testing was performed every 2 months; testing was performed quarterly thereafter.  

Results for the primary outcome: Among the total study population (N=699); n=319 subjects reached the primary outcome (45.6%). Rates of failure among each treatment group were as follows:  

  • Continued metformin monotherapy: 51.7% (95% confidence interval [CI], 45.3–58.2)  
  • Rosiglitazone + metformin: 38.6% (95% CI, 32.4–44.9)  
  • Metformin + intensive lifestyle-intervention program: 46.6% (95% CI, 40.2–53.0)   

Don’t miss slides on the TODAY study in our Slide Library: 

TODAY Study: Design 

TODAY Study: Eligibility Criteria and Run-in Period 

TODAY Study: Baseline Characteristics Among Randomized Subjects 

TODAY Study: Primary Outcome—Loss of Glycemic Control 

 This overview was created by KnowledgePoint360 Group, LLC, and was not associated with funding via an educational grant or a promotional interest. 

 

Last Modified: 11/15/2013