RecruitingPhase 2NCT07296484

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

Clofutriben And Placebo Phase 2 Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

Sponsor

Sparrow Pharmaceuticals

Enrollment

1,500 participants

Start Date

Nov 29, 2025

Study Type

INTERVENTIONAL

Conditions

Type 2 Diabetes Cortisol Excess

Summary

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial (CAPTAIN-T2D) is testing an intensive treatment approach for people with difficult-to-control type 2 diabetes, combining multiple medications to bring blood sugar closer to target. **You may be eligible if...** - You are 18 or older with an HbA1c of 7.5% or higher despite being on at least 2 diabetes medications at adequate, stable doses - You are currently using insulin (at least 0.3 units/kg/day) that has been stable with only minor adjustments - You have at least one of: 3 or more stable diabetes medications, a diabetes-related complication, high blood pressure requiring 2 medications, or are on insulin plus at least one other medication **You may NOT be eligible if...** - Your current medications have not been at stable, adequate doses for at least 3 months - Your blood sugar control is extremely poor (fasting glucose over 270 mg/dL on 2 separate days) - Your HbA1c has not been measured within 3 months using the current treatment regimen Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGclofutriben

HSD-1 inhibitor

DRUGPlacebo

Placebo

Locations(47)

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

Los Angeles Institute for Metabolic Research

Los Angeles, California, United States

Velocity Clinical Research, Los Angeles

Los Angeles, California, United States

Amicis Research Center- Nordhoff

Northridge, California, United States

Velocity Clinical Research, New Smyrna Beach

Edgewater, Florida, 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

Elixia SISU BHR - Springfield

Springfield, Massachusetts, 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

Lucas Research Inc

Morehead City, North Carolina, United States

Velocity Clinical Research, Cincinnati, Mt. Auburn

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, Anderson

Anderson, South Carolina, United States

Velocity Clinical Research, Austin

Austin, Texas, United States

Emory University School of Medicine

Dallas, Texas, United States

Velocity Clinical Research - Dallas

Dallas, 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

Velocity Clinical Research, Salt Lake City

West Jordan, Utah, United States

Velocity Clinical Research, Suffolk

Suffolk, Virginia, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07296484

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