Back to Trials
NCT06739122PHASE3Recruiting

A Study of Dulaglutide (LY2189265) 3.0 mg and 4.5 mg in Pediatric Participants With Type 2 Diabetes Mellitus (AWARD-PEDS PLUS)

Eli Lilly and Company

Start Date

1/10/2025

Completion Date

12/1/2027

Summary

The main purpose of this study is to evaluate additional dosing options for dulaglutide in pediatric participants with Type 2 Diabetes. Participation in this study will last about 8 months.

Eligibility Criteria

Age Range: 10 years to 17 years

Inclusion Criteria: * Have Type 2 diabetes treated with diet and exercise and metformin and/or basal insulin. Metformin and/or basal insulin dose must be stable for at least 8 weeks prior to screening. * Have a body weight ≥50 kilograms (kg) and Body Mass Index (BMI) of \>85th percentile Exclusion Criteria: * Have Type 1 diabetes * Have received treatment with any glucose-lowering agent(s) other than metformin, basal insulin, or dulaglutide within 8 weeks prior to screening * After the Type 2 diabetes diagnosis, have a history of diabetic ketoacidosis or hyperosmolar syndrome * Have had ≥1 episode of severe hypoglycemia and/or ≥1 episode of hypoglycemic unawareness within the last 6 months * Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2) * Have prior chronic, recurrent, or idiopathic pancreatitis, or known gallbladder disease * Have been treated with prescription drugs or over-the-counter medications that promote weight loss within 8 weeks prior to screening

Interventions

DRUG

Dulaglutide

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Type 2 Diabetes

Locations

University of Arizona

Tucson, Arizona 85724

United States

Arkansas Childrens Hospital

Little Rock, Arkansas 72202-3500

United States

Division of Endocrinology, Diabetes, and Metabolism

Los Angeles, California 90027

United States

UCLA Mattel Children's Hospital

Los Angeles, California 90095

United States

University of California, San Francisco

San Francisco, California 94158

United States

Children's Hospital of Colorado

Denver, Colorado 80045

United States

Yale Diabetes Research

New Haven, Connecticut 06511

United States

Emerson Clinical Research Institute

Washington D.C., District of Columbia 20009

United States

Children's National Medical Center

Washington D.C., District of Columbia 20010

United States

Nemours Children's Health

Jacksonville, Florida 32207

United States

D&H National Research Centers, Inc

Miami, Florida 33155

United States

AdventHealth Orlando

Orlando, Florida 32803

United States

D&H Tamarac Research Center, LLC

Tamarac, Florida 33321

United States

University of South Florida

Tampa, Florida 33612

United States

Children's Healthcare of Atlanta - Center for Advanced Pediatrics

Atlanta, Georgia 30329

United States

Centricity Research Columbus Endocrinology

Columbus, Georgia 31904

United States

St. Luke's Children's Endocrinology and Diabetes

Boise, Idaho 83712

United States

University of Illinois at Chicago

Chicago, Illinois 60612

United States

Center for Diabetes and Metabolic Diseases Indiana University

Indianapolis, Indiana 46202

United States

University of Iowa Stead Family Children's Hospitals

Iowa City, Iowa 52242

United States

Norton Children's Endocrinology

Louisville, Kentucky 40202

United States

Johns Hopkins University School of Medicine

Baltimore, Maryland 21287

United States

University of Mississippi Medical Center

Jackson, Mississippi 39216

United States

University of New Mexico Hospital

Albuquerque, New Mexico 87106

United States

WBMD Pediatrics

Buffalo, New York 14203

United States

Cohen Children's Medical Center Division of Pediatric Endocrinology

Hyde Park, New York 11042

United States

SUNY Upstate Medical University

Syracuse, New York 13210

United States

UNC Children's Hospital

Chapel Hill, North Carolina 27514

United States

Childrens Hospital Medical Center

Cincinnati, Ohio 45229

United States

Cleveland Clinic Childrens Outpatient Center

Cleveland, Ohio 44106

United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma 73104

United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania 19104

United States

St Christophers Hospital For Children

Philadelphia, Pennsylvania 19134

United States

Prisma Health Pediatric Endocrinology

Columbia, South Carolina 29203

United States

Prisma Health Midlands

Greenville, South Carolina 29615

United States

Research Institute of Dallas

Dallas, Texas 75231

United States

Texas Childrens Hospital

Houston, Texas 77030

United States

UT Health Houston

Houston, Texas 77030

United States

University of Utah

Salt Lake City, Utah 84112

United States

Seattle Children's Hospital

Seattle, Washington 98105

United States

Children's Wisconsin - Milwaukee Campus

Milwaukee, Wisconsin 53226

United States

Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

Buenos Aires, C1425

Argentina

Centro de Investigaciones Médicas Mar del Plata

Mar del Plata, B7600FYK

Argentina

INECO Neurociencias Oroño

Rosario, 2000

Argentina

Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L

San Miguel de Tucumán, T4000IHE

Argentina

Go Centro Medico San Nicolás

San Nicolás, 2900

Argentina

Centro de Estudios de Investigacion Metabolicos y Cardiovasculares

Ciudad Madero, 89440

Mexico

Hospital Angeles (HA) - Puebla

Puebla City, 72190

Mexico

Clínica Cemain

Tampico, 89210

Mexico

Innovacion y Desarrollo de Estrategias en Salud SA de CV

Tlalpan, 14090

Mexico

Arké SMO S.A de C.V

Veracruz, 91910

Mexico