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ACTIVE NOT RECRUITING

NCT06334133

PHASE3

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

Sponsor: vTv Therapeutics

View on ClinicalTrials.gov

Summary

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

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2024-06-14

Completion Date

2027-05

Last Updated

2026-07-28

Healthy Volunteers

Conditions

Diabetes Mellitus, Type 1

Interventions

DRUG

Cadisegliatin 800 mg QD

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

DRUG

Cadisegliatin 800 mg BID

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

DRUG

Placebo

Placebo (insulin alone)

Inclusion Criteria: * Individuals ≥18 years * Diagnosed T1DM with a minimum of 3 years since diagnosis * Has had at least 1 hypoglycemic event of Level 2 (glucose level \<54 mg/dL or \<3 mmol/L, \[CGM or SMBG confirmed\]) or Level 3 (defined as a severe hypoglycemia with altered mental state and/or physical status requiring assistance) in the last 2 months prior to Screening * HbA1c value of \<9.5% at Screening * Is currently on CSII (closed-loop systems are prohibited) or is on MDI for at least 6 months prior to the Screening Visit and is willing to stay on same type of insulin treatment and the current mode of insulin administration (CSII or MDI injection treatments) for the duration of the study * Must have been on a CGM device for at least 3 months prior to Screening Exclusion Criteria: * Has T2DM, monogenic diabetes, maturity-onset diabetes of the young, other unusual or rare forms of diabetes mellitus, or diabetes resulting from a secondary disease * Has been hospitalized for DKA within 3 months prior to Screening * Has uncontrolled hypothyroidism or hyperthyroidism * History of eating disorder within the last 2 years such as anorexia, bulimia, diabulimia or neglecting to give insulin to manipulate weight * Has an active or untreated malignancy, or has been in remission from malignancy for ≤5 years except well-treated basal cell or squamous cell skin cancer or cervical cancer in situ * Has used any of the following medications within the specified time periods - any non-insulin anti-diabetic therapies, e.g., sodium glucose cotransporter-2 (SGLT-2) inhibitors, glucagon-like peptide-1 (GLP-1) receptor agonists, metformin, sulfonylureas, dipeptidyl peptidase-4 (DPP-4) inhibitors, or pramlintide, alpha-glucosidase inhibitors, or glucose-dependent insulinotropic polypeptide agonists) or weight loss medications within 30 days prior to the Screening * Has used a hybrid closed-loop system (e.g., Medtronic 670G, Omnipod 5, or Tandem X2 with control IQ) or Do-It-Yourself looping within the last 30 days prior to the Screening Visit, and agrees to not start hybrid closed-loop systems or Do-It-Yourself looping during the study. * Has an estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2 utilizing the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation at Screening * Has uncontrolled hypertension prior to Screening

Locations (52)

Scottsdale Clinical Trials

Scottsdale, Arizona, United States

Baptist Health Center for Clinical Research

Little Rock, Arkansas, United States

Amicis Research Center

Granada Hills, 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

IMAX Clinical Trials

La Palma, California, United States

Paradigm Clinical Research - Modesto

Modesto, 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

Metabolic Research Institute, Inc

West Palm Beach, Florida, United States

Atlanta Diabetes Associates

Atlanta, Georgia, United States

Centricity Research - Columbus

Columbus, Georgia, United States

The Jones Center Clinical Research, LLC

Macon, 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

Massachusetts General Hospital Diabetes Research Center

Boston, Massachusetts, 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

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

Centricity Research Morehead City Multispecialty

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, 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

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

Velocity Clinical Research - Spokane

Spokane, Washington, United States

Solace Clinical Research

San Juan, Puerto Rico

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (52)