Skip to content
Bored Studies
RecruitingPhase 2

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

Sparrow Pharmaceuticals · NCT07296484

View Study & Apply (opens in a new tab)

Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
1500
US sites recruiting
61
Study start
November 29, 2025
Record last updated
October 6, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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).

Being studied: clofutriben; Placebo

Conditions: Type 2 Diabetes; Cortisol Excess

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Arizona Clinical Trials - Pecos

    Chandler, AZ 85225

    Site contact: Kamila Manager · 480-470-4000 · kojeda@azclinicaltrials.com

  • Arizona Clinical Trials - Broadway

    Tucson, AZ 85711

    Site contact: Leanne Manager · 480-470-4000 · lbuchenholz@azclinicaltrials.com

  • Ark Clinical Research - Fountain Valley

    Fountain Valley, CA 92708

    Site contact: Lizeth Manager · 323-588-1990 · lsuncin@velocityclinical.com

  • Velocity Clinical Research, Huntington Park

    Huntington Park, CA 90255

    Site contact: Tim Manager · 5135799911 · tpeterson@velocityclinical.com

  • Velocity Clinical Research - Gardena

    La Mesa, CA 91942

    Site contact: Tim Manager · 513-673-4057 · tpeterson@velocityclinical.com

  • Ark Clinical Research - Long Beach

    Long Beach, CA 90815

    Site contact: Mike Manager · 562-997-1000 · mdelgado@arkclinicalresearch.com

  • Los Angeles Institute for Metabolic Research

    Los Angeles, CA 90015

    Site contact: Lourdes Manager · (213) 373-8380 · lgaribay@metabolic.la

  • Velocity Clinical Research, Los Angeles

    Los Angeles, CA 90057

    Site contact: Tim Manager · 5135799911 · tpeterson@velocityclinical.com

  • Amicis Research Center- Nordhoff

    Northridge, CA 98433

    Site contact: Veronica Clinical Research Manager · (818) 929-7774 · veronica.macias@amicisresearch.com

  • Alliance Clinical San Diego

    San Diego, CA 92120

    Site contact: Sandra Manager · (858) 299-0009 · SMisic@allianceclinicalnetwork.com

  • Velocity Clinical Research, New Smyrna Beach

    Edgewater, FL 32132

    Site contact: Tim Manager · 513-673-4057 · tpeterson@velocityclinical.com

  • The Center for Diabetes and Endocrine Care

    Fort Lauderdale, FL 33312

    Site contact: Marie Study Coordinator · 954-963-7191 · mmartin@diabetes-endocare.com

  • Admed Research LLC

    Miami, FL 33173

    Site contact: Indiana Manager · 786-687-2882 · igonzalez@admedresearch.com

  • Suncoast Clinical Research, Inc

    New Port Richey, FL 34652

    Site contact: Cathy Manager · 727-849-4131 · cbarnes@suncoastclinicalresearch.com

  • Innovative Research Institute

    Port Charlotte, FL 33952

    Site contact: Lauren Manager · (+1) 2832276233 · l.ellis@medpace.com

  • Progressive Medical Research

    Port Orange, FL 32127

    Site contact: Nora Clinical Research Manager · 386-304-7070 · norab@progressivemedicalresearch.com

  • Conquest Research

    Winter Park, FL 32789

    Site contact: Malisa Manager · 407-916-0060 · malisa.agard@conquestresearch.com

  • Emory University School of Medicine

    Atlanta, GA 30303

    Site contact: Rohit Manager · 404-778-1695 · rohit.parab@emory.edu

  • IACT Health-Brookstone Centre Pkwy

    Columbus, GA 31904

    Site contact: kristina Manager · 706.321.0495 · kristina.erb@centricityresearch.com

  • Paradigm Clinical Research - Boise, ID

    Boise, ID 83709

    Site contact: Janaie Manager · 208-801-7440 · jbounsana@paradigm-research.com

  • Chicago Clinical Research Institute

    Chicago, IL 60607

    Site contact: Manognya Clinical Research Manager · 3127913241 · manognya@ccrii.us

  • Iowa Diabetes and Endocrinology Research Center

    West Des Moines, IA 50226

    Site contact: Crystal Manager · 515-207-7486 · choffman@iderc.com

  • Alliance for Multispecialty Research - Wichita East

    Wichita, KS 67226

    Site contact: Terry Manager · 316-689-6635 · terry.klein@amr-clinical.com

  • St. Elizabeth Healthcare

    Edgewood, KY 41017

    Site contact: Amber Manager · 859-655-1567 · amber.avery@stelizabeth.com

  • Velocity Clinical Research, Lafayette

    Lafayette, LA 70508

    Site contact: Tim Manager · 513-673-4057 · tpeterson@velocityclinical.com

  • NOLA Care Clinical Research

    Metairie, LA 70006

    Site contact: Rosina Manager · 504-427-6324 · rosinaducote@gmail.com

  • Tulane University School of Medicine

    New Orleans, LA 70112

    Site contact: Neha Manager · 5049889803 · nupadhyay@tulane.edu

  • Velocity Clinical Research, Rockville

    Rockville, MD 20854

    Site contact: Tim Manager · 513-673-4057 · tpeterson@velocityclinical.com

  • Elixia SISU BHR - Springfield

    Springfield, MA 011030

    Site contact: Darlene Manager · 5617970336 · darlene.djaba@empathxresearch.com

  • Oakland Medical Research Center

    Troy, MI 48085

    Site contact: Juliejo (Julie) Clinical Research Manager · 248-687-7412 · juliejolafave@msn.com

  • Velocity Clinical Research, Lincoln

    Lincoln, NE 68510

    Site contact: Tim Manager · 513-673-4057 · tpeterson@velocityclinical.com

  • Velocity Clinical Research, Omaha

    Omaha, NE 68134

    Site contact: Tim Manager · 513-673-4057 · tpeterson@velocityclinical.com

  • Alliance Clinical - Las Vegas

    Las Vegas, NV 89108

    Site contact: Stephanie Manager · (702) 680-1500 · sruvalcaba@allianceclinicalnetwork.com

  • Palm Research Center, Inc.

    Las Vegas, NV 89148

    Site contact: Raffaela Manager · 702-736-5161 · raffaela@palmresearchcenter.com

  • Albany Medical College

    Albany, NY 12203

    Site contact: Mohammed Manager · 518-264-4462 · ismailmoh@amc.edu

  • University of North Carolina at Chapel Hill

    Chapel Hill, NC 27514

    Site contact: Jessica Manager · 984-974-3004 · jessica_caffey@med.unc.edu

  • Physicians East

    Greenville, NC 27834

    Site contact: Kristen Manager · 252-413-6392 · ktaylor@physicianseast.com

  • Lucas Research Inc

    Morehead City, NC 28557

    Site contact: Christina Manager · 252-222-5700 · christina.tornes@centricityresearch.com

  • PMG Research of Wilmington, LLC

    Wilmington, NC 28401

    Site contact: Kevin Manager · 910.815.6108 · cannon1099@me.com

  • Velocity Clinical Research, Cincinnati, Mt. Auburn

    Cincinnati, OH 45219

    Site contact: Tim Manager · 513-673-4057 · tpeterson@velocityclinical.com

  • Velocity Clinical Research - Cincinnati, Blue Ash

    Cincinnati, OH 45242

    Site contact: Tim Manager · 513-673-4057 · tpeterson@velocityclinical.com

  • Endocrinology Associates, Inc

    Columbus, OH 43201

    Site contact: Edward Clinical Research Manager · 614-453-9999 · ek@endocrinology-associates.com

  • Remington Davis, Inc

    Columbus, OH 43215

    Site contact: Tsunami Clinical Research Manager · 614-487-2560 · Tbrisco@remdavis.com

  • Willamette Valley Clinical Studies

    Eugene, OR 97404

    Site contact: Patricia Manager · 541-461-0132 · drpatb@aol.com

  • Suburban Research Associates

    West Chester, PA 19380

    Site contact: Tom Manager · 610-891-9024 · tfrancis@suburbanresearch.com

  • Velocity Clinical Research, Anderson

    Anderson, SC 29621

    Site contact: Tim Manager · (864) 965-0190 · tpeterson@velocityclinical.com

  • Accellacare Charleston

    Mt. Pleasant, SC 29464

    Site contact: Dhruva Manager · (843) 849-1880 · dhruva.patel@accellacare.com

  • Velocity Clinical Research, Austin

    Austin, TX 78759

    Site contact: Tim Manager · 513-673-4057 · tpeterson@velocityclinical.com

  • Velocity Clinical Research - Dallas

    Dallas, TX 75230

    Site contact: Tim Manager · (972) 566-8631 · tpeterson@velocityclinical.com

  • Juno Research, LLC

    Houston, TX 77040

    Site contact: Lian manager · 713-779-5494 · lian_ramos@junoresearch.us

  • Radiance Clinical Research

    Lampasas, TX 76550

    Site contact: Lauren Clinical Research Manager · 512-556-4130 · lgarner@radianceclinical.com

  • Alliance Clinical - Lewisville (Epic Clinical Research)

    Lewisville, TX 75057

    Site contact: Jessica Manager · (469) 361-8007 · jpowell@allianceclinicalnetwork.com

  • Texas Valley Clinical Research - Mission, TX

    Mission, TX 78572

    Site contact: Omar Manager · 9568887400 · gonzalez.md@tvcrmission.com

  • Texas Diabetes & Endocrinology, P.A. - Round Rock

    Round Rock, TX 78681

    Site contact: Olivia Clinical Research Manager · 512-334-3505 · knutty@tderesearch.com

  • Diabetes & Glandular Disease Clinic, P.A.

    San Antonio, TX 78229

    Site contact: Myriam Manager · 210-614-8612 · myriam.turner@dgdclinic.com

  • Texas Valley Clinical Research - San Antonio TX

    San Antonio, TX 78251

    Site contact: Diana Manager · 2105431990 · diana@tvcrtrials.com

  • Elevate Clinical Research

    Seabrook, TX 77586

    Site contact: Olga Clinical Research Manager · 832-271-1598 · olga.konshina@elevateclinical.com

  • Texas Valley Clinical Research, LLC

    Weslaco, TX 78596

    Site contact: Czarina Manager · 956-431-8090 · czarina@tvcrtrials.com

  • Velocity Clinical Research, Salt Lake City

    West Jordan, UT 84088

    Site contact: Tim Clinical Research Manager · 5135799911 · tpeterson@velocityclinical.com

  • Velocity Clinical Research, Suffolk

    Suffolk, VA 23435

    Site contact: Tim Manager · (757) 996-4200 · tpeterson@velocityclinical.com

+ 1 more on the official record.

All diabetes studies in Arizona →
Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D) (NCT07296484) | Bored Studies