RecruitingType 2 DiabetesCortisol Excess

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

Eligible age

18+ yrs

Accepts

All genders

Locations

23 states

Healthy volunteers

See if you qualify for this study

Answer a few quick questions about your location and health. Takes about a minute.

Check my eligibility →

About this study

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).

Sponsor: Sparrow Pharmaceuticals

You may qualify if…

✓ 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).
✓ Adequate total daily insulin is defined as at least 0.3 units/kg/day. Insulin dose will be deemed stable with adjustments of up to 20% total daily dose during the 3 months prior to Screening 1 or between Screening 1 and Day 1.
✓ Use of insulin pumps or insulin brand changes (e.g., due to insurance change or shortage) are to be discussed with the MM.
✓ At least one of the following
✓ ≥3 stable and adequate ADMs;

You may not qualify if…

✕ 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.
✕ Investigator considers the patient will otherwise be unwilling or unable to complete the trial.
✕ Night-shift worker or otherwise habitually awake from 23:00 to 07:00 h.
✕ Evidence for significant hypoglycemia while on their current diabetic treatment regimen(This includes episodes of symptomatic Level 3 hypoglycemia requiring external assistance for recovery, or CGM-documented prolonged \[\>15 min\] or repeated episodes of either Level 2 hypoglycemia leading to \>1%, or Level 1 hypoglycemia leading to \>4%, in "time below range" within 3 months prior to Screening 1 or between Screening 1 and Day 1).
✕ Any of the following in medical history: