Actively Recruiting
Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)
Led by Sparrow Pharmaceuticals · Updated on 2026-05-12
1500
Participants Needed
52
Research Sites
134 weeks
Total Duration
On this page
AI-Summary
What this Trial 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).
CONDITIONS
Official Title
Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age at least 18 years.
- HbA1c 7.5% or higher documented within 3 months before screening.
- Treatment with stable and adequate doses of at least two injectable or oral antidiabetic medications.
- Adequate total daily insulin dose of at least 0.3 units/kg/day if applicable.
- At least one of the following: three or more stable antidiabetic medications, diabetes complications, hypertension requiring two or more antihypertensive medications, adequately dosed basal plus prandial insulin with another antidiabetic medication, adequately dosed incretin agonist with another antidiabetic medication, history or evidence of osteoporosis or non-traumatic fracture, or diagnosis of non-malignant hypercortisolism unresponsive or ineligible for surgery.
- Elevated cortisol after dexamethasone suppression test (post-DST cortisol level >1.8 µg/dL and serum dexamethasone ≥140 ng/dL), or established diagnosis of neoplastic hypercortisolism.
- HbA1c 7.5% or higher at Screening 2.
- No changes or initiation of hypertension medications within 1 month before Day 1.
You will not qualify if you...
- New-onset diabetes within the past year.
- Unwillingness to maintain or adjust current glucose-lowering medications as directed.
- Unwillingness to comply with trial procedures including continuous glucose monitoring.
- Night-shift work or being awake habitually from 11 PM to 7 AM.
- Significant hypoglycemia episodes requiring assistance or prolonged/repeated hypoglycemia on monitoring.
- History of type 1 diabetes, latent autoimmune diabetes, or familial maturity-onset diabetes of the young.
- Conditions interfering with HbA1c measurement such as certain hemoglobinopathies or recent blood transfusions.
- Hypersensitivity or severe reaction to dexamethasone.
- Certain medical conditions including pheochromocytoma, eating disorders, glucocorticoid resistance, multiple sclerosis, significant liver impairment, untreated or uncontrolled sleep apnea, substance use disorders exceeding set limits, untreated or uncontrolled major psychiatric disorders, or any condition likely to interfere with trial participation.
- Use of excluded medications or investigational drugs within defined washout periods.
- Women of childbearing potential not willing to use effective contraception or strict abstinence during and 90 days after the trial.
- Pregnancy or current breastfeeding.
- Specific criteria at Screening 2 including high risk or treatment plans for endogenous Cushing syndrome, severe uncontrolled hypertension, positive drug screens, low kidney function, poorly controlled thyroid disease, elevated liver enzymes, or known hypersensitivity to clofutriben or its components.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 52 locations
1
Arizona Clinical Trials - Pecos
Chandler, Arizona, United States, 85225
Actively Recruiting
2
Arizona Clinical Trials - Broadway
Tucson, Arizona, United States, 85711
Actively Recruiting
3
Ark Clinical Research - Fountain Valley
Fountain Valley, California, United States, 92708
Actively Recruiting
4
Velocity Clinical Research, Huntington Park
Huntington Park, California, United States, 90255
Actively Recruiting
5
Velocity Clinical Research - Gardena
La Mesa, California, United States, 91942
Actively Recruiting
6
Ark Clinical Research - Long Beach
Long Beach, California, United States, 90815
Actively Recruiting
7
Los Angeles Institute for Metabolic Research
Los Angeles, California, United States, 90015
Actively Recruiting
8
Velocity Clinical Research, Los Angeles
Los Angeles, California, United States, 90057
Actively Recruiting
9
Amicis Research Center- Nordhoff
Northridge, California, United States, 98433
Actively Recruiting
10
Velocity Clinical Research, New Smyrna Beach
Edgewater, Florida, United States, 32132
Actively Recruiting
11
The Center for Diabetes and Endocrine Care
Fort Lauderdale, Florida, United States, 33312
Actively Recruiting
12
Admed Research LLC
Miami, Florida, United States, 33173
Actively Recruiting
13
Suncoast Clinical Research, Inc
New Port Richey, Florida, United States, 34652
Not Yet Recruiting
14
Innovative Research Institute
Port Charlotte, Florida, United States, 33952
Not Yet Recruiting
15
Progressive Medical Research
Port Orange, Florida, United States, 32127
Actively Recruiting
16
IACT Health-Brookstone Centre Pkwy
Columbus, Georgia, United States, 31904
Actively Recruiting
17
Chicago Clinical Research Institute
Chicago, Illinois, United States, 60607
Actively Recruiting
18
Velocity Clinical Research, Sioux City
Sioux City, Iowa, United States, 51106
Actively Recruiting
19
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, United States, 50226
Actively Recruiting
20
St. Elizabeth Healthcare
Edgewood, Kentucky, United States, 41017
Not Yet Recruiting
21
Velocity Clinical Research, Lafayette
Lafayette, Louisiana, United States, 70508
Actively Recruiting
22
NOLA Care Clinical Research
Metairie, Louisiana, United States, 70006
Actively Recruiting
23
Tulane University School of Medicine
New Orleans, Louisiana, United States, 70112
Actively Recruiting
24
Medstar Health Research Institute
Olney, Maryland, United States, 20832
Actively Recruiting
25
Velocity Clinical Research, Rockville
Rockville, Maryland, United States, 20854
Actively Recruiting
26
Elixia SISU BHR - Springfield
Springfield, Massachusetts, United States, 011030
Actively Recruiting
27
Oakland Medical Research Center
Troy, Michigan, United States, 48085
Actively Recruiting
28
Velocity Clinical Research, Lincoln
Lincoln, Nebraska, United States, 68510
Actively Recruiting
29
Velocity Clinical Research, Omaha
Omaha, Nebraska, United States, 68134
Actively Recruiting
30
Palm Research Center, Inc.
Las Vegas, Nevada, United States, 89148
Actively Recruiting
31
Velocity Clinical Research, Binghamton
Binghamton, New York, United States, 13905
Actively Recruiting
32
Endocrine Associates of Long Island, P.C.
Smithtown, New York, United States, 11787
Actively Recruiting
33
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
34
Physicians East
Greenville, North Carolina, United States, 27834
Actively Recruiting
35
Lucas Research Inc
Morehead City, North Carolina, United States, 28557
Actively Recruiting
36
PMG Research of Wilmington, LLC
Wilmington, North Carolina, United States, 28401
Not Yet Recruiting
37
Velocity Clinical Research, Cincinnati, Mt. Auburn
Cincinnati, Ohio, United States, 45219
Actively Recruiting
38
Velocity Clinical Research - Cincinnati, Blue Ash
Cincinnati, Ohio, United States, 45242
Actively Recruiting
39
Endocrinology Associates, Inc
Columbus, Ohio, United States, 43201
Actively Recruiting
40
Remington Davis, Inc
Columbus, Ohio, United States, 43215
Actively Recruiting
41
Willamette Valley Clinical Studies
Eugene, Oregon, United States, 97404
Not Yet Recruiting
42
Velocity Clinical Research, Anderson
Anderson, South Carolina, United States, 29621
Actively Recruiting
43
Velocity Clinical Research, Austin
Austin, Texas, United States, 78759
Actively Recruiting
44
Emory University School of Medicine
Dallas, Texas, United States, 75230
Actively Recruiting
45
Velocity Clinical Research - Dallas
Dallas, Texas, United States, 75230
Actively Recruiting
46
Juno Research, LLC
Houston, Texas, United States, 77040
Actively Recruiting
47
Radiance Clinical Research
Lampasas, Texas, United States, 76550
Actively Recruiting
48
Texas Diabetes & Endocrinology, P.A. - Round Rock
Round Rock, Texas, United States, 78681
Actively Recruiting
49
Elevate Clinical Research
Seabrook, Texas, United States, 77586
Actively Recruiting
50
Texas Valley Clinical Research, LLC
Weslaco, Texas, United States, 78596
Actively Recruiting
51
Velocity Clinical Research, Salt Lake City
West Jordan, Utah, United States, 84088
Actively Recruiting
52
Velocity Clinical Research, Suffolk
Suffolk, Virginia, United States, 23435
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
5
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