139 Assessing the inclusion of women and minority populations in ClinicalTrials.gov results in studies focused on type 2 diabetes and GLP1 drugs

Objectives/Goals: This study aims to evaluate diversity of participants in GLP-1 T2DKM clinical research with regard to sex, race, and ethnicity by using results data available through the ClinicalTrials.gov database. Sample population estimates for studies were calculated using the 2020 Census and compared within groups with respect to sex, race, and ethnicity. Methods/Study Population: The public ClinicalTrials.gov database was searched for interventional studies with GLP1 inclusion as treatment (n = 2,397). This search was then filtered to studies where results were reported (n = 772). From these studies, 466 studies focused on type 2 diabetes as a condition and thus became the analysis dataset. Participant and protocol information for these 466 studies were obtained from the clinical trials transformation initiative (CTTI) as an AACT data download. Observed to expected ratios were calculated for each subgroup-based population estimates from the 2020 Census and using the baseline counts of participants for studies where sex, race, and ethnicity were provided. In addition to within group comparisons, study characteristics (e.g. phase) were included in models to assess influence of covariates. Results/Anticipated Results: Of the 466 studies, 430 (92%) reported sex, 171 (37%) reported race, and 145 (31%) reported Hispanic ethnicity. Among those found to be underrepresented in studies (defined as a ratio < 1): females (mean = 0.89, median = 0.92); Black/African Americans (mean = 0.88, median = 0.39). Hispanic or Latinos mean ratio was 1.16 (95% CL: 0.97, 1.35) but had the least available data. When including covariates in the models, there were statistically significant differences in ratios with respect to sex as females had significantly lower odds compared to males (ratio > = 1), with the odds being about 21% of those for males. With respect to race, Black or African American individuals had significantly lower odds (about 32% of those of White individuals) (ratio > = 1). Discussion/Significance of Impact: This study reveals significant underrepresentation of females (mean ratio 0.89) and Black/African Americans (mean ratio 0.88) in clinical trials for GLP-1 drugs in type 2 diabetes. These disparities highlight the need for more inclusive research to ensure diverse populations benefit equally from medical advancements.