Adults with early-onset type 2 diabetes (aged 18 to 39 years) are severely under-represented in diabetes clinical research trials

Aims/Hypotheses: Early-onset adult type 2 diabetes (diagnosed aged 18-39 years) is increasingly prevalent and associated with poor long-term outcomes. However, we hypothesised that individuals with early-onset adult type 2 diabetes are underrepresented in the prominent research trials that underpin type 2 diabetes management guidelines.

Methods: We reviewed the mean age of the study populations recruited to 90 prominent trials in type 2 diabetes, including 37 cardio-renal outcomes trials across a range of pharmacological, non-pharmacological and multi-factorial interventions, 28 trials from the Phase III programmes of three representative glucose-lowering therapies used routinely in clinical practice (empagliflozin, liraglutide and sitagliptin), and 25 prominent trials of diabetes self-management education and support or intensive lifestyle interventions (diet or supervised exercise training). We then estimated the number of individuals within these trials that were aged between 18 and 39 years.

Results: Across all 90 trials, the mean age of 268,978 participants was 63 years (range 51 to 69 years in individual trials). In 73 trials (81 %), <5 % of participants were estimated to be 18-39 years, despite this age group representing ~15-20 % of the adult type 2 diabetes population. Twenty-nine trials (32 %; total 164,953 participants) excluded individuals less than 40 years altogether.

Conclusions/interpretation: Guidelines for early-onset adult type 2 diabetes are extrapolated predominantly from evidence in older individuals. Strategies to support the participation of individuals with early-onset adult type 2 diabetes in future research are imperative to ensure guidelines for these high-risk individuals are evidence-based.