The University of Texas Health Science Center at San Antonio
The purpose of this study is to assess the effect and effectiveness of Relacorilant on improving the glucose levels in the blood, thus potentially improving glucose control in patients with hard to control diabetes. This study involves the use of an investigational drug called Relacorilant. "Investigational" means that the drug has not yet been approved by the U.S. Food \& Drug Administration (FDA) for treating "mild hypercortisolism" in patients with diabetes. Cortisol is a "stress hormone". The excess production of cortisol can rise blood sugar (glucose) levels and worsen diabetes. Those disturbances might be corrected by the study medication Relacorilant to improve the state of your diabetes. This study will evaluate the effects of Relacorilant on glucose control and its safety profile. Although the safety of this drug has been tested in prior human research studies, some side effects may not yet be known.
The objective of the study is to investigate the mechanisms by which glucocorticoid receptor (GR) antagonism with relacorilant improves glucose homeostasis in patients with difficult-to-control type 2 diabetes (T2D) and confirmed endogenous hypercortisolism. Each patient serves as their own control to assess the mechanistic nature of the study. Comparisons made between pre- and post-treatment outcomes. This within-subject design allows detailed assessment of metabolic changes in response to treatment.
Inclusion Criteria: 1. Age between 18 and 75 years. 2. Males or females 3. HbA1c between 7.5% and 10.5% 4. Type 2 diabetes with at least one of the following: * Taking ≥ 3 glucose-lowering drugs * Taking 2 glucose lowering medication and 2 anti-hypertensive drugs. * Taking insulin and any other glucose lowering drugs * Taking ≥ 2 glucose-lowering drugs and presence of microvascular (retinopathy, nephropathy, neuropathy) or ≥ macrovascular (heart attack, heart failure, peripheral vascular disease, atrial fibrillation) disease 5. No changes in diabetes medications in the 4 weeks pr…
A capsule that will be given once daily starting at 100mg and increasing gradually to 400mg once a day.