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RECRUITING Phase 2 ClinicalTrials.gov

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

Sponsor: Sparrow Pharmaceuticals • ClinicalTrials.gov ID: NCT07296484

Registry updated: 2026-10-06
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Description

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).

Interventions

  • clofutriben (Drug)
    HSD-1 inhibitor
  • Placebo (Drug)
    Placebo

Eligibility criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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 * Pregnancy (including a positive urine test) or current breast feeding. From Screening 2 • Prior probability of undiagnosed endogenous Cushing syndrome based on either of: * wo morning serum cortisol values after dexamethasone suppression \>5.0 mcg/dL together with plasma dexamethasone \>140 ng/mL; or * a morning serum cortisol value after dexamethasone suppression \>1.8 mcg/dL, together with plasma dexamethasone \>140 ng/mL and any one of the following that is not attributable to an etiology other than endogenous Cushing's syndrome: * supraclavicular/dorsocervical fat accumulation; * irounding of the face (especially compared with prior photos); * skin changes (violaceous striae, skin thinning, or excessive bruising); * proximal muscle weakness on exam; or * history of deep vein thrombosis/pulmonary embolism. * Plans for, or medically unable to forego, treatment for endogenous Cushing syndrome or ACS within the next 8 months. (For clarity, patients with EnCS or ACS, not having such treatment plans, and medically able to forego treatment for 8 months may enroll if otherwise eligible). * Severe, poorly controlled hypertension (mean systolic BP \>160 mmHg or mean diastolic BP \>100 mmHg) at Screening 2 or between Screening 2 and Day 1, including by at-home monitoring. (Such patients will be eligible to rescreen for Part 2 when they restore BP \<160/100 mmHg for 1 month on a new stable medication regimen). * Positive urine screen for recreational drugs (except tetrahydrocannabinol (THC)). * Glomerular filtration rate (GFR) (determined using Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\]) \<45 mL/min/1.73 m². * Poorly controlled hyperthyroidism/hypothyroidism (confirmed by TSH or Free thyroxine \[fT4\]). * Liver enzymes \>3 × upper limit of normal (ULN) (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or bilirubin \>1.5 × ULN.(excepting benign conditions such as Gilbert's) * Known hypersensitivity to clofutriben or to any of the product

Conditions

Type 2 Diabetes Cortisol Excess

Locations

  • Arizona Clinical Trials - Pecos — Chandler, Arizona, United States
  • Arizona Clinical Trials - Broadway — Tucson, Arizona, United States
  • Ark Clinical Research - Fountain Valley — Fountain Valley, California, United States
  • Velocity Clinical Research, Huntington Park — Huntington Park, California, United States
  • Velocity Clinical Research - Gardena — La Mesa, California, United States
  • Ark Clinical Research - Long Beach — Long Beach, California, United States
  • Los Angeles Institute for Metabolic Research — Los Angeles, California, United States
  • Velocity Clinical Research, Los Angeles — Los Angeles, California, United States
  • Amicis Research Center- Nordhoff — Northridge, California, United States
  • Alliance Clinical San Diego — San Diego, California, United States
  • Velocity Clinical Research, New Smyrna Beach — Edgewater, Florida, United States
  • The Center for Diabetes and Endocrine Care — Fort Lauderdale, Florida, United States
  • Admed Research LLC — Miami, Florida, United States
  • Suncoast Clinical Research, Inc — New Port Richey, Florida, United States
  • Innovative Research Institute — Port Charlotte, Florida, United States
  • Progressive Medical Research — Port Orange, Florida, United States
  • Conquest Research — Winter Park, Florida, United States
  • Emory University School of Medicine — Atlanta, Georgia, United States
  • IACT Health-Brookstone Centre Pkwy — Columbus, Georgia, United States
  • Paradigm Clinical Research - Boise, ID — Boise, Idaho, United States
  • Chicago Clinical Research Institute — Chicago, Illinois, United States
  • Iowa Diabetes and Endocrinology Research Center — West Des Moines, Iowa, United States
  • Alliance for Multispecialty Research - Wichita East — Wichita, Kansas, United States
  • St. Elizabeth Healthcare — Edgewood, Kentucky, United States
  • Velocity Clinical Research, Lafayette — Lafayette, Louisiana, United States
  • NOLA Care Clinical Research — Metairie, Louisiana, United States
  • Tulane University School of Medicine — New Orleans, Louisiana, United States
  • Velocity Clinical Research, Rockville — Rockville, Maryland, United States
  • Elixia SISU BHR - Springfield — Springfield, Massachusetts, United States
  • Oakland Medical Research Center — Troy, Michigan, United States
  • Velocity Clinical Research, Lincoln — Lincoln, Nebraska, United States
  • Velocity Clinical Research, Omaha — Omaha, Nebraska, United States
  • Alliance Clinical - Las Vegas — Las Vegas, Nevada, United States
  • Palm Research Center, Inc. — Las Vegas, Nevada, United States
  • Albany Medical College — Albany, New York, United States
  • University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
  • Physicians East — Greenville, North Carolina, United States
  • Lucas Research Inc — Morehead City, North Carolina, United States
  • PMG Research of Wilmington, LLC — Wilmington, North Carolina, United States
  • Velocity Clinical Research, Cincinnati, Mt. Auburn — Cincinnati, Ohio, United States
  • Velocity Clinical Research - Cincinnati, Blue Ash — Cincinnati, Ohio, United States
  • Endocrinology Associates, Inc — Columbus, Ohio, United States
  • Remington Davis, Inc — Columbus, Ohio, United States
  • Willamette Valley Clinical Studies — Eugene, Oregon, United States
  • Suburban Research Associates — West Chester, Pennsylvania, United States
  • Velocity Clinical Research, Anderson — Anderson, South Carolina, United States
  • Accellacare Charleston — Mt. Pleasant, South Carolina, United States
  • Velocity Clinical Research, Austin — Austin, Texas, United States
  • Velocity Clinical Research - Dallas — Dallas, Texas, United States
  • Juno Research, LLC — Houston, Texas, United States
  • Radiance Clinical Research — Lampasas, Texas, United States
  • Alliance Clinical - Lewisville (Epic Clinical Research) — Lewisville, Texas, United States
  • Texas Valley Clinical Research - Mission, TX — Mission, Texas, United States
  • Texas Diabetes & Endocrinology, P.A. - Round Rock — Round Rock, Texas, United States
  • Diabetes & Glandular Disease Clinic, P.A. — San Antonio, Texas, United States
  • Texas Valley Clinical Research - San Antonio TX — San Antonio, Texas, United States
  • Elevate Clinical Research — Seabrook, Texas, United States
  • Texas Valley Clinical Research, LLC — Weslaco, Texas, United States
  • Velocity Clinical Research, Salt Lake City — West Jordan, Utah, United States
  • Velocity Clinical Research, Suffolk — Suffolk, Virginia, United States
  • Conquest Research — Vienna, Virginia, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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