High Medication Burden in Individuals With Difficult-to-Control Type 2 Diabetes: Clinical Characteristics From the CATALYST Study

CATALYST (NCT05772169) was the largest prospective study to date to assess the prevalence of hypercortisolism in individuals with difficult-to-control type 2 diabetes (T2D), finding a prevalence of 23.8% (n=252/1,057). With a participant cohort of >1,000, the study was uniquely positioned to explore demographic and clinical characteristics associated with difficult-to-control T2D. Here we describe the characteristics of the CATALYST Part 1 population. Individuals with hemoglobin A1c (HbA1c) 7.5–11.5%, despite taking multiple antihyperglycemic medications, were screened for hypercortisolism using the 1-mg overnight dexamethasone suppression test (DST). Those with known causes of false-positive DSTs were excluded. The study population had a mean age of 60.7 years, 45% were female, 71% were White, 19% were African American, and 24% were Hispanic/Latino. Mean HbA1c was 8.8%, and mean systolic blood pressure (SBP) was 127.6 mmHg. 31% had SBP ≥135 mm/Hg. 43% were taking ≥4 glucose-lowering medications, including sodium-glucose cotransporter 2 inhibitors (52%), glucagon-like peptide-1 receptor agonists (48%), and tirzepatide (10%). Antihypertensive medications were used by 82% of participants, with 27% taking ≥3 antihypertensives. Lipid-modifying medications (primarily statins) were used by 83%, psychiatric medication by 30%, and analgesic medications by 30% of participants. Cardiac disorders were present in 33% and 21% of participants and hypertension was present in 89% and 79% of participants with and without hypercortisolism, respectively. In summary, CATALYST participants had a high medication and comorbid disease burden, with T2D that remained difficult to control despite multiple glucose-lowering medications. In addition, many participants had elevated SBP despite extensive use of antihypertensive medications.