ESPE Abstracts

Metformin was the first and only drug approved in 1999 for use in youth with type 2 diabetes (T2D) based on a small, randomized clinical trial. Insulin was also approved but this was based only on the effective use of insulin in children with T1D. For more than 20 years, no new drugs had been approved for use in pediatric T2D based on a randomized study. A major reason why many of the new drugs have not been approved in pediatrics is that adolescents with T2D are difficult to recruit for these studies. For example, adolescents with T2D often miss clinic visits and are lost to follow-up and compliance with taking meds and carrying out other diabetes-related tasks is poor. Many patients are also excluded due to behavioral problems, depression and other psychiatric disorders. However, formation of the Pediatric Diabetes Consortium (PDC) of leading pediatric diabetes treatment centers in the US was an important turning point, since a primary aim of the PDC is to improve the care of adolescents with T2D by making drugs with proven effectiveness in adults available to youth with T2D. The PDC has already accomplished its current primary goal by participation in the following studies:

• Exenatide by once weekly injection (approved)

• Oral dapagliflozin (in analysis of study outcomes)

• Phase III dapagliflozin and saxagliptin vs placebo study (nearing completion of randomization)

• Dinamo Phase III empagliflozin and linagliptin vs placebo (nearing completion of enrollment)

• Dinamo Mono study (in early recruitment phase)

• Liraglutide by daily injection (approved)

• Oral Semaglutide (in early recruitment phase)

• Phase III Alogliptin versus Placebo Study (nearing completion)

We strongly believe that the results of these and future randomized clinical trials will transform the care of youth with type 2 diabetes in the future.