Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSparrow Pharmaceuticals
About this trial
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).
Eligibility criteria
Qualifiers
From Screening 1
Age at least 18 years.
HbA1c ≥7.5% documented within 3 months prior to Screening 1. (The historical HbA1c value must have been obtained after at least 2 months on the current [as of Screening 1] regimen).
Treatment with stable and adequate doses of ≥2 injectable or oral ADMs. (An ADM will be deemed stable if the dose has been the same for at least 3 months prior to Screening 1 and without change between Screening 1 and Day 1) (An ADM dose will be deemed adequate if it is at or above the maximal labelled dose, or a sub-maximal, but not starting, dose if limited by tolerability (confer with MM if less than half-maximal dose).
Disqualifiers
New-onset diabetes (onset <1 year in the past).
Unwillingness to maintain with current glucose-lowering regimen during the trial.
Unwillingness to adjust, add, replace, or discontinue current or other glucose-lowering medications during the trial as directed by the investigator.
Unwillingness to comply with CGM or other trial procedures.
Trial design
Treatments tested in this trial
- clofutriben
- Placebo
Treatment groups
1,500 Participants
are divided into 5 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov