Prevalence
In CATALYST, the largest US prospective trial ever conducted to investigate the prevalence of endogenous hypercortisolism, 24% (252/1057) of patients with difficult-to-control type 2 diabetes (T2D) were diagnosed with hypercortisolism1,2*
CATALYST was a prospective, phase 4 study with two parts. The first part (Screening Phase) assessed the prevalence of endogenous hypercortisolism in 1057 patients with difficult-to-control T2D diagnosed ≥1 year prior and defined as HbA1c 7.5%-11.5% AND taking ≥3 T2D medications OR insulin and other T2D medication(s) OR ≥2 T2D medications AND the presence of ≥1 microvascular or macrovascular complication AND/OR concomitant hypertension requiring ≥2 hypertension medications. Hypercortisolism was defined as a post 1-mg DST cortisol >1.8 μg/dL with AM dexamethasone ≥140 ng/dL. In the second part (Treatment Phase), patients with hypercortisolism who met inclusion/exclusion criteria (n=136) were randomized (2:1) to receive either Korlym or placebo for 24 weeks in a double-blind, placebo-controlled manner. The primary endpoint was the reduction of HbA1c between these groups. Please see full study design on the CATALYST Study Results page.1,2
Hyperglycemia driven by hypercortisolism
The underlying cause of hyperglycemia secondary to hypercortisolism is fundamentally different than hyperglycemia driven by T2D.3,4
With hyperglycemia secondary to hypercortisolism, excess cortisol may be the underlying cause of elevated glucose levels4
Hypercortisolism is usually caused by an adenoma located on the adrenal gland (adrenocorticotropic hormone [ACTH] independent), an adenoma on the pituitary gland, or an ectopic tumor (both considered ACTH dependent)5
Increased risk of hypercortisolism
A meta-analysis identified clinical characteristics of patients with T2D that increased the likelihood of being diagnosed with hypercortisolism6:
increased risk with
difficult-to-control T2D
(n=2184)‡
increased risk with
insulin therapy
(n=1400)§
increased risk with
T2D and hypertension
(n=2283)¶
‡DerSimonian and Laird (DSL) method (OR, 3.4; 95% CI, 2.12-5.67; P<0.0001) and Hartung-Knapp-Sidik-Jonkman (HKSJ) method (OR, 3.60; 95% CI, 2.03-6.41; P=0.004).
§DSL method (OR, 1.92; 95% CI, 1.05-3.50; P=0.034) and HKSJ method (OR, 2.13; 95% CI, 0.81-5.65; P=0.100).
¶DSL method (OR, 2.29; 95% CI, 1.07-4.91; P=0.034) and HKSJ method (OR, 2.50; 95% CI, 0.30-21.01; P=0.205).