Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Type 2 Diabetes, Cortisol Excess

In brief

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).

Key facts

Study ID

NCT07296484

Run by

Sparrow Pharmaceuticals

People needed

1500

Starts

2025-11-29

Expected to finish

2028-06-30

Last updated by the study team

2026-06-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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;
• diabetes complication (retinopathy, nephropathy, neuropathy, atherosclerotic heart disease);
• hypertension requiring ≥2 adequately dosed AHMs;
• adequately dosed basal or basal plus prandial insulin in addition to at least 1 other ADM; and
• adequately dosed incretin agonist (a single or combination agent counts as one ADM) in addition to at least 1 other ADM;
• evidence or history of osteoporosis or non-traumatic fracture (e.g., vertebral body compression);
• or established diagnosis of a neoplastic (non-malignant) source of hypercortisolism and have failed, are ineligible for, or declined surgery.
• At DST • Post-DST cortisol level >1.8 µg/dL and serum dexamethasone ≥140 ng/dL. Patients with an established diagnosis of neoplastic hypercortisolism do not require a DST.
• At Screening 2
• HbA1c ≥7.5% at Screening 2. At Day 1
• No change in, or initiation of, medications for hypertension within 1 month prior to Day 1.

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:
• Type 1 diabetes mellitus (T1D), latent autoimmune diabetes in adults (LADA), or familial forms of maturity-onset diabetes of the young (MODY);
• A hemoglobinopathy or other condition which may interfere with measurement of HbA1c (e.g., sickle cell disease HbSS or other variants HbEE thalassemia, hemolytic anemia, recent blood transfusion);
• Hypersensitivity or severe reaction to dexamethasone;
• Pheochromocytoma, or suspicion thereof;
• Anorexia, or other eating disorder;
• Glucocorticoid resistance;
• Multiple sclerosis;
• Significant hepatic impairment (e.g., Child-Pugh Class B or C);
• Idiopathic thrombocytopenic purpura;
• Untreated or inadequately controlled moderate-to-severe sleep apnea (apnea-hypopnea index ≥15). (Patients whose condition has been well controlled with Continuous Positive Airway Pressure (CPAP) use for at least 3 months prior to Screening 1 are not excluded. Patients with a STOP-BANG score 5-8 should be referred for a sleep study outside the trial and may rescreen if found not to have moderate-to-severe sleep apnea);
• Current alcohol consumption >14 units/week or >4 units in a single day for males, or >7 units/week or >3 units in a single day for females. (Patients with a CAGE score 2-4 should be evaluated further outside the trial and may be rescreened if found not to have an alcohol [or other substance] use disorder);
• Untreated or inadequately controlled major depressive disorder, generalized anxiety disorder, bipolar disorder, post-traumatic stress disorder, or schizophrenia.(Patients whose condition has been well controlled with stable medical therapy, or has been asymptomatic, for at least 3 months prior to Screening 1 are not excluded); or
• Any other medical condition (including malignancy) that is likely to interfere with trial assessments or the patient's ability to complete the trial.
• Any of the following in medication history:
• Any of the excluded medications listed in Section 6.9;
• Any investigational drug within 4 weeks or within less than five times the drug's half-life, whichever is longer, prior to Screening 1 or between Screening 1 and Day 1;
• Woman of childbearing potential (WOCBP) not willing to adhere to highly effective contraception or strict abstinence for the duration of the trial and for 90 days post completion/discontinuation; and

Where it is running

• Tulane University School of Medicine — New Orleans, Louisiana, United States (enrolling)
• Elixia SISU BHR - Springfield — Springfield, Massachusetts, United States (enrolling)
• Arizona Clinical Trials - Pecos — Chandler, Arizona, United States (enrolling)
• Arizona Clinical Trials - Broadway — Tucson, Arizona, United States (enrolling)
• Ark Clinical Research - Long Beach — Long Beach, California, United States (enrolling)
• Velocity Clinical Research, Rockville — Rockville, Maryland, United States (enrolling)
• Velocity Clinical Research, Los Angeles — Los Angeles, California, United States (enrolling)
• Velocity Clinical Research, Huntington Park — Huntington Park, California, United States (enrolling)
• Velocity Clinical Research - Gardena — La Mesa, California, United States (enrolling)
• Velocity Clinical Research, New Smyrna Beach — Edgewater, Florida, United States (enrolling)
• The Center for Diabetes and Endocrine Care — Fort Lauderdale, Florida, United States (enrolling)
• Admed Research LLC — Miami, Florida, United States (enrolling)
• Los Angeles Institute for Metabolic Research — Los Angeles, California, United States (enrolling)
• Ark Clinical Research - Fountain Valley — Fountain Valley, California, United States (enrolling)
• Progressive Medical Research — Port Orange, Florida, United States (enrolling)
• Emory University School of Medicine — Atlanta, Georgia, United States (enrolling)
• IACT Health-Brookstone Centre Pkwy — Columbus, Georgia, United States (enrolling)
• Amicis Research Center- Nordhoff — Northridge, California, United States (enrolling)
• Chicago Clinical Research Institute — Chicago, Illinois, United States (enrolling)
• Velocity Clinical Research, Sioux City — Sioux City, Iowa, United States (enrolling)
• Iowa Diabetes and Endocrinology Research Center — West Des Moines, Iowa, United States (enrolling)
• St. Elizabeth Healthcare — Edgewood, Kentucky, United States (enrolling)
• Velocity Clinical Research, Lafayette — Lafayette, Louisiana, United States (enrolling)
• NOLA Care Clinical Research — Metairie, Louisiana, United States (enrolling)
• Oakland Medical Research Center — Troy, Michigan, United States (enrolling)

Full record on ClinicalTrials.gov

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