Phase 2 Study of Clofutriben or Placebo for Type 2 Diabetes Patients with Elevated Cortisol

What this Trial Is About

Researchers are evaluating the drug clofutriben, an 11-hydroxysteroid dehydrogenase type 1 HSD-1 inhibitor, in adults with type 2 diabetes who have elevated cortisol levels. This Phase 2 trial aims to understand how different doses of clofutriben affect blood sugar control and to find suitable doses for further studies. The trial involves two parts an initial screening phase and a treatment phase, conducted in multiple centers with participants randomly assigned to groups. The first part, lasting about 5 to 9 weeks, includes screening tests such as the dexamethasone suppression test to identify eligible participants with elevated cortisol. In the second part, participants are randomly assigned to receive either placebo or one of four doses of clofutriben taken once daily by mouth for 24 weeks. After treatment, a follow-up phone call occurs 4 weeks later to check on participants. Participants will undergo various assessments including blood tests to measure cortisol levels and blood sugar control glycated hemoglobin A1c and fasting plasma glucose. The study monitors changes in these measures from baseline through the 24-week treatment period. The trial also tracks safety and treatment adherence. Total participation time includes screening, a 24-week treatment, and a follow-up period, extending to the trials completion date in mid-2028.

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)