Mifepristone Improves A1C in T2D With Hypercortisolism
Results from the prevalence phase of the study, presented last year, indicated that 24% (253) of the 1055 patients enrolled had hypercortisolism, as determined by dexamethasone suppression test. The figure was surprising, as the expected prevalence was 8%.
The current data were presented at the American Diabetes Association (ADA) 85th Scientific Sessions and simultaneously published in Diabetes Care .
'These findings demonstrate a potentially promising treatment solution' for these patients, who are often frustrated with their diabetes care, said study author John Buse, MD, PhD, Verne S. Caviness Distinguished Professor of Medicine at the University of North Carolina School of Medicine, Chapel Hill, North Carolina, in a press release.
The CATALYST Trial: Latest Results
In the second phase of CATALYST, individuals who had abnormal cortisol suppression were offered the opportunity to take part in a randomized trial of mifepristone, a medication that reduces the effects of cortisol. It is currently FDA approved for the treatment of elevated blood glucose in patients with hypercortisolism and prediabetes or T2D.
The trial took place at 36 sites in the US. A total of 136 patients with T2D (A1c of 7.5%-11.5%, who were on multiple medications) and hypercortisolism were randomized 2:1 to mifepristone (300-900 mg once daily; 91 patients) or placebo (45 patients) for 24 weeks, with stratification by presence/absence of an adrenal imaging abnormality.
Almost 40% of the patients were women, and the mean age was 63 years. The mean A1c was 8.55%, and mean BMI was 33.3. Twenty-eight percent of participants had adrenal imaging abnormalities.
The medication reduced A1c by 1.5% (95% CI, -1.79 to -1.14). For those taking placebo, A1c declined 0.2% from 8.41% to 8.36% (95% CI, -0.56 to 0.27).
Within the first 12 weeks, 30% of those taking mifepristone reduced or discontinued
fast-acting insulin compared to 11% of those taking placebo. And half reduced or discontinued long-acting insulin compared to 13% of those taking placebo.
'As their A1c came down, they didn't need the insulin,' Buse told reporters at a press conference at the meeting.
Patients taking mifepristone also lost 4.4 kg of body weight and had a 5.2 cm (2.05 in) reduction in waist circumference from baseline. However, almost 50% of those taking mifepristone discontinued due to adverse events compared to just 18% of those taking placebo.
A total of 62% of patients on mifepristone reported having treatment-related adverse events, said Buse, adding that people on mifepristone primarily experience glucocorticoid withdrawal syndrome or hypokalemia.
Mifepristone 'is a challenging drug to use,' he said, and 'it's important to set expectations appropriately with patients about steroid withdrawal symptoms and how to manage them.'
CATALYST already demonstrated that hypercortisolism was likely a culprit in almost a quarter of patients with poorly controlled diabetes, and screening with a dexamethasone suppression test is relatively easy, said Buse.
The treatment phase of CATALYST showed 'that identifying and addressing hypercortisolism is a novel path to improving diabetes care in millions of people worldwide,' he added.
The CATALYST investigators 'believe that there's sufficient evidence now to suggest guideline changes at the American Diabetes Association and other international health organizations.'
This study was funded by Corcept Therapeutics. Buse disclosed serving on an advisory panel/as a consultant for Altimmune, Antag Therapeutics, Amgen, APstem Therapeutics, Aqua Medical, AstraZeneca, Boehringer Ingelheim, CeQur, Corcept Therapeutics, Dexcom, Eli Lilly, embecta, GentiBio, Glyscend, Insulet, Medtronic MiniMed, Mellitus Health, Metsera, Novo Nordisk, Pendulum Therapeutics, Praetego, Stability Health, Tandem Diabetes Care, Terns Pharmaceuticals, Vertex Pharmaceuticals, and Zealand Pharma; and having stocks/shares in Glyscend, Mellitus Health, Metsera, Pendulum Therapeutics, Praetego, and Stability Health.
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