Phase 2Recruiting
Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)
Clofutriben And Placebo Phase 2 Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)
- Sponsor
- Sparrow Pharmaceuticals (Industry)
- Enrolment
- 1,500 planned
- Conditions
- Type 2 Diabetes; Cortisol Excess
- Interventions
- clofutriben; Placebo
- Ages
- adults, older adults
- Registry
- NCT07296484
Full record on ClinicalTrials.gov
From the registry
CAPTAIN-T2D will take place in two parts. Part 1 (Screening) will evaluate patients with type 2 diabetes and elevated cortisol risk factors for trial eligibility and the presence of elevated cortisol. Participants deemed eligible from Part 1 will be randomized to either clofutriben or placebo in the double-blind (participant and investigator), dose-ranging, interventional Part 2 (Treatment).
Primary outcomes
- Percentage of patients with both morning serum cortisol >1.8 mg/dL and morning plasma dexamethasone >=140 ng/dL (single composite endpoint) after a single dexamethasone 1 mg dose taken the prior night.
- Glycated hemoglobin A1c (%) change from baseline to Week 24 by treatment.
History
Study completion expected
Primary completion expected
Last registry update
Registered
Started