Abstract 9547: Prevalence and Characteristics of Registered Diabetes Clinical Trials With Cardiovascular Outcomes: An Analysis of Clinicaltrials.gov

Abstract

Introduction: Cardiovascular disease (CVD) is a well-known sequela of diabetes. Interventions to address diabetes often fail to assess clinically-relevant cardiovascular event reduction. Recently, emphasis has shifted to include CVD events in diabetes trials. We characterized diabetes trials that include CVD events as a primary or secondary outcome. Methods: Interventional (non-observational) clinical trials registered to ClinicalTrials.gov from 1/1/2009 through 12/31/2019 were abstracted. Diabetes trials and characteristics were selected from the “Clinical Trials Transformation Initiative” SQL database, using the United States National Library of Medicine medical subject heading terms (MeSH). Trials were restricted based upon inclusion of CVD (Major Adverse Cardiac Events [MACE], cardiovascular death, fatal stroke, fatal myocardial infarction [MI], non-fatal MI, non-fatal stroke) outcomes as identified in primary or secondary outcome fields. Results: Among 2470 diabetes trial, only 49 (1.9%) included CVD events as a primary or secondary outcome. Median trial size was 571 (range 12, 934000), with 40.8% including multiple sites and 42.9% including a site in the US and another country. Most trials had been completed (53.1%) and were Phase 3 or 4 (36.7% and 20.4%, respectively). Trials were predominantly randomized (91.8%), parallel assignment (89.8%), masked (75.5%), included a control arm (87.8%), and industry-funded (59.2%). Over half did not report results on ClinicalTrials.gov (55.1%). Only 2 diabetes trials with CVD outcomes were registered in both 2009 and 2019 each (range 2-7). Conclusions: Despite increased emphasis on clinically-relevant outcomes, particularly with new therapeutics, <2% of diabetes trials registered to ClinicalTrials.gov included CVD outcomes, which did not meaningfully increase from 2009. However, diabetes trials with CVD outcomes were primarily industry funded and well-designed. Given the importance of clinically-relevant outcomes, particularly the increased risk of CVD seen with diabetes, greater emphasis on CVD outcomes in diabetes-specific trials is needed.