Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)
NCT ID: NCT07296484
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
1500 participants
INTERVENTIONAL
2025-12-31
2028-06-30
Brief Summary
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Detailed Description
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The trial consists of two parts.
Part 1 (Screening) will last between approximately 5 to 9 weeks for most participants. The screening period duration allows for (sequentially) initial eligibility screen, dexamethasone suppression test, and further eligibility assessments.
During Part 2 (Treatment), participants will be randomized to placebo or one of four clofutriben doses. Part 2 will last 24 weeks with a follow-up phone call 4 weeks after the last dose of trial medication.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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Dose 1
clofutriben .2 mg oral tablet daily
clofutriben
HSD-1 inhibitor
Dose 2
clofutriben 2mg oral tablet daily
clofutriben
HSD-1 inhibitor
Dose 3
clofutriben 6mg oral tablet daily
clofutriben
HSD-1 inhibitor
Dose 4
clofutriben 12 mg oral tablet daily
clofutriben
HSD-1 inhibitor
placebo
placebo control oral tablet daily
Placebo
Placebo
Interventions
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clofutriben
HSD-1 inhibitor
Placebo
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Sparrow Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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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
Velocity Clinical Research, Los Angeles
Los Angeles, California, United States
Amicis Research Center- Nordhoff
Northridge, California, United States
The Center for Diabetes and Endocrine Care
Fort Lauderdale, Florida, United States
Admed Research LLC
Miami, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
IACT Health-Brookstone Centre Pkwy
Columbus, Georgia, United States
Chicago Clinical Research Institute
Chicago, Illinois, United States
Velocity Clinical Research, Sioux City
Sioux City, Iowa, United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, 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
Medstar Health Research Institute
Olney, Maryland, United States
Velocity Clinical Research, Rockville
Rockville, Maryland, 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
Palm Research Center, Inc.
Las Vegas, Nevada, United States
Velocity Clinical Research, Binghamton
Binghamton, New York, United States
Endocrine Associates of Long Island, P.C.
Smithtown, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Physicians East
Greenville, North Carolina, United States
Centricity Research LR Morehead City NC
Morehead City, North Carolina, United States
Velocity Clinical Research, Cincinnati, Mt. Auburn
Cincinnati, Ohio, United States
Velocity Clinical Research, New Smyrna Beach
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
Velocity Clinical Research, Austin
Austin, Texas, United States
Juno Research, LLC
Houston, Texas, United States
Radiance Clinical Research
Lampasas, Texas, United States
Texas Diabetes & Endocrinology, P.A. - Round Rock
Round Rock, Texas, United States
Elevate Clinical Research
Seabrook, Texas, United States
Texas Valley Clinical Research, LLC
Weslaco, Texas, United States
Wasatch Clinical Research, LLC
Salt Lake City, Utah, United States
Velocity Clinical Research, Salt Lake City
West Jordan, Utah, United States
Countries
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Facility Contacts
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Kurt Manager
Role: primary
Kurt Manager
Role: primary
Kurt Manager
Role: primary
Veronica Clinical Research Manager
Role: primary
Marie Study Coordinator
Role: primary
Nora Clinical Research Manager
Role: primary
Manognya Clinical Research Manager
Role: primary
Kurt Manager
Role: primary
Kurt Manager
Role: primary
Juliejo (Julie) Clinical Research Manager
Role: primary
Kurt Manager
Role: primary
Kurt Manager
Role: primary
Kurt Manager
Role: primary
Kurt Manager
Role: primary
Kurt Manager
Role: primary
Kurt Manager
Role: primary
Edward Clinical Research Manager
Role: primary
Tsunami Clinical Research Manager
Role: primary
Kurt Manager
Role: primary
Lian manager
Role: primary
Lauren Clinical Research Manager
Role: primary
Olivia Clinical Research Manager
Role: primary
Olga Clinical Research Manager
Role: primary
Kurt Clinical Research Manager
Role: primary
Other Identifiers
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SPI-62-CL-2006
Identifier Type: -
Identifier Source: org_study_id