RecruitingPhase 3NCT06334133

Cadisegliatin as Adjunctive Therapy to Insulin in Participants With Type 1 Diabetes

Cadisegliatin as Adjunctive Therapy in Type 1 Diabetes: A 26-Week Double-Blind, Randomized, Placebo-Controlled Phase 3 Study

Sponsor

vTv Therapeutics

Enrollment

150 participants

Start Date

Jun 14, 2024

Study Type

INTERVENTIONAL

Conditions

Diabetes Mellitus, Type 1

Summary

This is a Phase 3 trial of cadisegliatin as adjunctive therapy to insulin in participants with Type 1 Diabetes Mellitus.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a new drug called cadisegliatin, taken alongside insulin, can reduce dangerous low blood sugar episodes (hypoglycemia) in people with type 1 diabetes who struggle with unpredictable sugar drops. **You may be eligible if...** - You are 18 years or older - You have had type 1 diabetes for at least 3 years - You have had at least one significant low blood sugar episode (glucose below 54 mg/dL, or an episode requiring help from another person) in the past 2 months - Your HbA1c (3-month average blood sugar) is below 9.5% - You have been using an insulin pump or multiple daily injections for at least 6 months - You have been using a continuous glucose monitor (CGM) for at least 3 months **You may NOT be eligible if...** - You are using a closed-loop (automated) insulin delivery system - You have significant kidney, liver, or heart disease - You are pregnant or planning to become pregnant 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

DRUGCadisegliatin 800 mg QD

Cadisegliatin is an orally bioavailable small-molecule glucokinase activator; adjunctive therapy to insulin.

DRUGCadisegliatin 800 mg BID

Cadisegliatin is an orally bioavailable small-molecule glucokinase activator; adjunctive therapy to insulin.

DRUGPlacebo

Placebo (insulin alone)

Locations(58)

Scottsdale Clinical Trials

Scottsdale, Arizona, United States

Baptist Health Center for Clinical Research

Little Rock, Arkansas, United States

Advanced Metabolic Care & Research Institute, Inc. (AMCR)

Escondido, California, United States

MD Studies, Inc

Fountain Valley, California, United States

AME Clinical Research

Huntington Beach, California, United States

310 Clinical Research

Inglewood, California, United States

Scripps Whittier Diabetes Institute

La Jolla, California, United States

Paradigm Clinical Research - Modesto

Modesto, California, United States

Amicis Research Center

Northridge, California, United States

Velocity Clinical Research

San Bernardino, California, United States

Paradigm Clinical Research Centers LLC

San Diego, California, United States

Acclaim Clinical Research

San Diego, California, United States

The Lundquist Institute

Torrance, California, United States

Focus Clinical Research

West Hills, California, United States

Denver Endocrinology Diabetes and Thyroid Center

Englewood, Colorado, United States

BayCare Health Systems

Clearwater, Florida, United States

ALL Medical Research, LLC

Cooper City, Florida, United States

Excellence Medical and Research

Miami Gardens, Florida, United States

Metabolic Research Institute, Inc

West Palm Beach, Florida, United States

Atlanta Diabetes Associates

Atlanta, Georgia, United States

East Coast Institute for Research, LLC

Canton, Georgia, United States

Centricity Research - Columbus

Columbus, Georgia, United States

The Jones Center Clinical Research, LLC

Macon, Georgia, United States

Endocrine Research Solutions, Inc

Roswell, Georgia, United States

Paradigm Clinical Research

Boise, Idaho, United States

DM Clinical Research

Indianapolis, Indiana, United States

Accellacare - McFarland

Ames, Iowa, United States

Iowa Diabetes and Endocrinology Research Center

West Des Moines, Iowa, United States

Johnson County Clin-Trials, LLC

Lenexa, Kansas, United States

MedStar Good Samaritan Hospital

Baltimore, Maryland, United States

Profound Research LLC

Farmington Hills, Michigan, United States

Excel Clinical Research

Las Vegas, Nevada, United States

Palm Research Center

Las Vegas, Nevada, United States

Palm Research Center

Las Vegas, Nevada, United States

Vector Clinical Trials

Reno, Nevada, United States

AMC Community Endocrinology

Albany, New York, United States

Jacobi Medical Center

The Bronx, New York, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Javarra Inc.

Charlotte, North Carolina, United States

Physician's East PA

Greenville, North Carolina, United States

Lucas Research, Inc

Morehead City, North Carolina, United States

Diabetes & Endocrinology Associates of Stark County, Inc

Canton, Ohio, United States

John Muir Physician Network Clinical Research Center

Concord, Ohio, United States

Velocity Clinical Research - Medford

Medford, Oregon, United States

Velocity Clinical Research

Medford, Oregon, United States

University of Pennsylvania Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, United States

Circle Clinical Research

Sioux Falls, South Dakota, United States

Texas Diabetes and Endocrinology, P.A

Austin, Texas, United States

Velocity Clinical Research - Dallas

Dallas, Texas, United States

Tekton Research, LLC

McKinney, Texas, United States

SMS Clinical Research LLC

Mesquite, Texas, United States

Southern Endocrinology Associates PA

Mesquite, Texas, United States

Diabetes & Glandular Disease Clinic, P.A.

San Antonio, Texas, United States

Consano Clinical Research

Shavano Park, Texas, United States

Advanced Research Institute - Ogden

Ogden, Utah, United States

Wasatch Clinical Research, LLC

Salt Lake City, Utah, United States

University of Washington Diabetes Institute

Seattle, Washington, United States

Citta Clinical Research, LLC

Spokane, Washington, United States

View Full Details on ClinicalTrials.gov

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

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NCT06334133

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