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Lewisville (Epic Clinical Research)","Lewisville","75057",{"type":54,"coordinates":744},[745,746],-96.99417,33.04623,{"lat":746,"lon":745},[749],{"name":541,"role":62,"phone":750,"phoneExt":44,"email":751},"(469) 361-8007","jpowell@allianceclinicalnetwork.com",{"facility":753,"status":171,"city":754,"state":690,"zip":755,"country":52,"cosmosGeoPoint":756,"geoPoint":760,"contacts":761},"Texas Valley Clinical Research - Mission, TX","Mission","78572",{"type":54,"coordinates":757},[758,759],-98.32529,26.21591,{"lat":759,"lon":758},[762],{"name":763,"role":62,"phone":764,"phoneExt":44,"email":765},"Omar Manager","9568887400","gonzalez.md@tvcrmission.com",{"facility":767,"status":48,"city":768,"state":690,"zip":769,"country":52,"cosmosGeoPoint":770,"geoPoint":774,"contacts":775},"Texas Diabetes & Endocrinology, P.A. - Round Rock","Round Rock","78681",{"type":54,"coordinates":771},[772,773],-97.6789,30.50826,{"lat":773,"lon":772},[776],{"name":777,"role":62,"phone":778,"phoneExt":44,"email":779},"Olivia Clinical Research Manager","512-334-3505","knutty@tderesearch.com",{"facility":781,"status":48,"city":782,"state":690,"zip":783,"country":52,"cosmosGeoPoint":784,"geoPoint":788,"contacts":789},"Diabetes & Glandular Disease Clinic, P.A.","San Antonio","78229",{"type":54,"coordinates":785},[786,787],-98.49363,29.42412,{"lat":787,"lon":786},[790],{"name":791,"role":62,"phone":792,"phoneExt":793,"email":794},"Myriam Manager","210-614-8612","1532","myriam.turner@dgdclinic.com",{"facility":796,"status":171,"city":782,"state":690,"zip":797,"country":52,"cosmosGeoPoint":798,"geoPoint":800,"contacts":801},"Texas Valley Clinical Research - San Antonio TX","78251",{"type":54,"coordinates":799},[786,787],{"lat":787,"lon":786},[802],{"name":803,"role":62,"phone":804,"phoneExt":44,"email":805},"Diana Manager","2105431990","diana@tvcrtrials.com",{"facility":807,"status":48,"city":808,"state":690,"zip":809,"country":52,"cosmosGeoPoint":810,"geoPoint":814,"contacts":815},"Elevate Clinical Research","Seabrook","77586",{"type":54,"coordinates":811},[812,813],-95.02548,29.56412,{"lat":813,"lon":812},[816],{"name":817,"role":62,"phone":818,"phoneExt":44,"email":819},"Olga Clinical Research Manager","832-271-1598","olga.konshina@elevateclinical.com",{"facility":821,"status":48,"city":822,"state":690,"zip":823,"country":52,"cosmosGeoPoint":824,"geoPoint":828,"contacts":829},"Texas Valley Clinical Research, LLC","Weslaco","78596",{"type":54,"coordinates":825},[826,827],-97.99084,26.15952,{"lat":827,"lon":826},[830],{"name":831,"role":62,"phone":832,"phoneExt":44,"email":833},"Czarina Manager","956-431-8090","czarina@tvcrtrials.com",{"facility":835,"status":48,"city":836,"state":837,"zip":838,"country":52,"cosmosGeoPoint":839,"geoPoint":843,"contacts":844},"Velocity Clinical Research, Salt Lake City","West Jordan","Utah","84088",{"type":54,"coordinates":840},[841,842],-111.9391,40.60967,{"lat":842,"lon":841},[845],{"name":846,"role":62,"phone":105,"phoneExt":44,"email":106},"Tim Clinical Research Manager",{"facility":848,"status":48,"city":849,"state":850,"zip":851,"country":52,"cosmosGeoPoint":852,"geoPoint":856,"contacts":857},"Velocity Clinical Research, Suffolk","Suffolk","Virginia","23435",{"type":54,"coordinates":853},[854,855],-76.58496,36.72836,{"lat":855,"lon":854},[858],{"name":104,"role":62,"phone":859,"phoneExt":44,"email":106},"(757) 996-4200",{"type":861,"investigatorFullName":44,"investigatorTitle":44,"investigatorAffiliation":44,"oldNameTitle":44,"oldOrganization":44},"SPONSOR","100615736",false,"NCT07296484","Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)","Clofutriben And Placebo Phase 2 Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)","CAPTAIN-T2D","Inclusion Criteria:\n\n* From Screening 1\n\n  * Age at least 18 years.\n  * 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).\n  * 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).\n  * Adequate total daily insulin is defined as at least 0.3 units\u002Fkg\u002Fday. 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.\n  * Use of insulin pumps or insulin brand changes (e.g., due to insurance change or shortage) are to be discussed with the MM.\n  * At least one of the following\n\n    * ≥3 stable and adequate ADMs;\n    * diabetes complication (retinopathy, nephropathy, neuropathy, atherosclerotic heart disease);\n    * hypertension requiring ≥2 adequately dosed AHMs;\n    * adequately dosed basal or basal plus prandial insulin in addition to at least 1 other ADM; and\n    * adequately dosed incretin agonist (a single or combination agent counts as one ADM) in addition to at least 1 other ADM;\n    * evidence or history of osteoporosis or non-traumatic fracture (e.g., vertebral body compression);\n    * or established diagnosis of a neoplastic (non-malignant) source of hypercortisolism and have failed, are ineligible for, or declined surgery.\n\nAt DST • Post-DST cortisol level \\>1.8 µg\u002FdL and serum dexamethasone ≥140 ng\u002FdL. Patients with an established diagnosis of neoplastic hypercortisolism do not require a DST.\n\nAt Screening 2\n\n* HbA1c ≥7.5% at Screening 2. At Day 1\n* No change in, or initiation of, medications for hypertension within 1 month prior to Day 1.\n\nExclusion Criteria:\n\n* New-onset diabetes (onset \\\u003C1 year in the past).\n* Unwillingness to maintain with current glucose-lowering regimen during the trial.\n* Unwillingness to adjust, add, replace, or discontinue current or other glucose-lowering medications during the trial as directed by the investigator.\n* Unwillingness to comply with CGM or other trial procedures.\n* Investigator considers the patient will otherwise be unwilling or unable to complete the trial.\n* Night-shift worker or otherwise habitually awake from 23:00 to 07:00 h.\n* 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).\n* Any of the following in medical history:\n\n  * Type 1 diabetes mellitus (T1D), latent autoimmune diabetes in adults (LADA), or familial forms of maturity-onset diabetes of the young (MODY);\n  * 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);\n  * Hypersensitivity or severe reaction to dexamethasone;\n  * Pheochromocytoma, or suspicion thereof;\n  * Anorexia, or other eating disorder;\n  * Glucocorticoid resistance;\n  * Multiple sclerosis;\n  * Significant hepatic impairment (e.g., Child-Pugh Class B or C);\n  * Idiopathic thrombocytopenic purpura;\n  * 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);\n  * Current alcohol consumption \\>14 units\u002Fweek or \\>4 units in a single day for males, or \\>7 units\u002Fweek 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);\n  * 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\n  * Any other medical condition (including malignancy) that is likely to interfere with trial assessments or the patient's ability to complete the trial.\n  * Any of the following in medication history:\n  * Any of the excluded medications listed in Section 6.9;\n  * 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;\n  * 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\u002Fdiscontinuation; and\n  * Pregnancy (including a positive urine test) or current breast feeding.\n\nFrom Screening 2\n\n• Prior probability of undiagnosed endogenous Cushing syndrome based on either of:\n\n* wo morning serum cortisol values after dexamethasone suppression \\>5.0 mcg\u002FdL together with plasma dexamethasone \\>140 ng\u002FmL; or\n* a morning serum cortisol value after dexamethasone suppression \\>1.8 mcg\u002FdL, together with plasma dexamethasone \\>140 ng\u002FmL and any one of the following that is not attributable to an etiology other than endogenous Cushing's syndrome:\n* supraclavicular\u002Fdorsocervical fat accumulation;\n* irounding of the face (especially compared with prior photos);\n* skin changes (violaceous striae, skin thinning, or excessive bruising);\n* proximal muscle weakness on exam; or\n* history of deep vein thrombosis\u002Fpulmonary embolism.\n* 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).\n* 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 \\\u003C160\u002F100 mmHg for 1 month on a new stable medication regimen).\n* Positive urine screen for recreational drugs (except tetrahydrocannabinol (THC)).\n* Glomerular filtration rate (GFR) (determined using Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\]) \\\u003C45 mL\u002Fmin\u002F1.73 m².\n* Poorly controlled hyperthyroidism\u002Fhypothyroidism (confirmed by TSH or Free thyroxine \\[fT4\\]).\n* 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)\n* Known hypersensitivity to clofutriben or to any of the product","ALL","18 Years",{"count":872,"type":873},1500,"ESTIMATED","INTERVENTIONAL",[876],"PHASE2","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).",[879,880],"Type 2 Diabetes","Cortisol Excess",[882,883,884],"hypercortisolism","Cortisol excess","elevated cortisol","2026-06-15",{"date":887,"type":888},"2026-06-17","ACTUAL",{"date":890,"type":888},"2025-11-29",{"date":892,"type":873},"2028-06-30",{"name":5,"class":6},60]