Actively Recruiting
Clofutriben and Placebo Phase 2 Trial Against Intractable Type 2 Diabetes (CAPTAIN-T2D)
Led by Sparrow Pharmaceuticals · Updated on 2026-05-12
1500
Participants Needed
52
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating clofutriben, an 11-hydroxysteroid dehydrogenase type 1 (HSD-1) inhibitor, in patients with type 2 diabetes and elevated cortisol. This Phase 2, randomized, double-blind, placebo-controlled trial aims to understand how different doses of clofutriben affect blood sugar control and to identify doses suitable for further studies. The study includes patients with type 2 diabetes who have elevated cortisol levels and are already on stable diabetes treatments. The trial has two parts. Part 1 is a screening phase lasting about 5 to 9 weeks, which includes eligibility checks and a dexamethasone suppression test to confirm elevated cortisol. In Part 2, lasting 24 weeks, eligible participants are randomly assigned to take one of four doses of clofutriben or a placebo, all given as daily oral tablets. After completing the treatment, participants receive a follow-up phone call four weeks later. Participants will have their blood sugar control and cortisol levels monitored through blood tests, including glycated hemoglobin A1c and fasting plasma glucose, at the start and during the treatment period. The study also tracks the percentage of patients with specific cortisol and dexamethasone levels after testing. Safety and adherence will be checked throughout, with ongoing assessments to understand the drug's impact over the 24-week treatment and follow-up period.
CONDITIONS
Brief Title
Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old
- HbA1c 7.5% or higher documented within 3 months before screening
- On stable and adequate doses of at least two injectable or oral anti-diabetic medications
- Stable insulin dose of at least 0.3 units/kg/day if using insulin
- Elevated cortisol levels confirmed by dexamethasone suppression test or established diagnosis of neoplastic hypercortisolism
- No change in hypertension medications within 1 month before treatment start
- Willing to maintain current glucose-lowering regimen during the trial
You will not qualify if you...
- New-onset diabetes diagnosed less than 1 year ago
- Unwillingness to maintain or adjust glucose-lowering medications as directed
- Night-shift worker or regularly awake between 11 PM and 7 AM
- History of significant hypoglycemia requiring assistance or frequent low blood sugar episodes
- Type 1 diabetes, latent autoimmune diabetes, or familial forms of diabetes
- Conditions interfering with HbA1c measurement like hemoglobinopathies
- Severe liver impairment or untreated moderate-to-severe sleep apnea
- Significant alcohol use above specified limits
- Untreated or uncontrolled psychiatric disorders
- Pregnant or breastfeeding women or women not using effective contraception
- Positive urine drug screen for recreational drugs (except THC)
- Poorly controlled hypertension or thyroid disease
- Severe kidney impairment (GFR <45 mL/min/1.73 m2)
- Known hypersensitivity to clofutriben or dexamethasone
- Use of excluded medications or investigational drugs within 4 weeks prior to screening
- Plans for treatment for endogenous Cushing syndrome within the next 8 months
- Medical conditions likely to interfere with trial assessments or completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 5 to 9 weeks
Participants are screened for eligibility to participate in the trial.
Screening visits include initial eligibility screening, dexamethasone suppression test, and further eligibility assessments.
Duration - 24 weeks
Participants receive daily oral tablets of either clofutriben at one of four doses or placebo to evaluate effects on glycemic control.
Visits occur during the treatment period to monitor progress and safety.
Duration - 4 weeks after last dose
Participants have a follow-up phone call to check on their status after completing the treatment period.
1 phone call
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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