RecruitingPhase 3NCT06739122

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

A Phase 3, Open-Label, Multicenter, Single-Arm Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of Dulaglutide 3.0 mg and 4.5 mg in Pediatric Participants 10 to Less Than 18 Years of Age With Type 2 Diabetes Mellitus

Sponsor

Eli Lilly and Company

Enrollment

55 participants

Start Date

Jan 10, 2025

Study Type

INTERVENTIONAL

Conditions

Type 2 Diabetes

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

Min Age: 10 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study tests two higher doses of dulaglutide (a weekly injectable medication for blood sugar control) in children and teenagers with type 2 diabetes who are not achieving good control with metformin or basal insulin alone. Dulaglutide is already approved in adults; this trial extends the research to younger patients. **You may be eligible if...** - You are a child or teenager with type 2 diabetes - You weigh at least 50 kg (about 110 lbs) and have a BMI above the 85th percentile for your age - You are currently being treated with diet/exercise plus metformin and/or basal insulin, with a stable dose for at least 8 weeks **You may NOT be eligible if...** - You have type 1 diabetes - You have used other blood sugar-lowering medications (besides metformin or basal insulin) in the past 8 weeks - You have certain other health conditions that make this medication unsafe 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

DRUGDulaglutide

Administered SC

Locations(51)

University of Arizona

Tucson, Arizona, United States

Arkansas Childrens Hospital

Little Rock, Arkansas, United States

Division of Endocrinology, Diabetes, and Metabolism

Los Angeles, California, United States

UCLA Mattel Children's Hospital

Los Angeles, California, United States

University of California, San Francisco

San Francisco, California, United States

Children's Hospital of Colorado

Denver, Colorado, United States

Yale Diabetes Research

New Haven, Connecticut, United States

Emerson Clinical Research Institute

Washington D.C., District of Columbia, United States

Children's National Medical Center

Washington D.C., District of Columbia, United States

Nemours Children's Health

Jacksonville, Florida, United States

D&H National Research Centers, Inc

Miami, Florida, United States

AdventHealth Orlando

Orlando, Florida, United States

D&H Tamarac Research Center, LLC

Tamarac, Florida, United States

University of South Florida

Tampa, Florida, United States

Children's Healthcare of Atlanta - Center for Advanced Pediatrics

Atlanta, Georgia, United States

Centricity Research Columbus Endocrinology

Columbus, Georgia, United States

St. Luke's Children's Endocrinology and Diabetes

Boise, Idaho, United States

University of Illinois at Chicago

Chicago, Illinois, United States

Center for Diabetes and Metabolic Diseases Indiana University

Indianapolis, Indiana, United States

University of Iowa Stead Family Children's Hospitals

Iowa City, Iowa, United States

Norton Children's Endocrinology

Louisville, Kentucky, United States

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

University of New Mexico Hospital

Albuquerque, New Mexico, United States

WBMD Pediatrics

Buffalo, New York, United States

Cohen Children's Medical Center Division of Pediatric Endocrinology

Hyde Park, New York, United States

SUNY Upstate Medical University

Syracuse, New York, United States

UNC Children's Hospital

Chapel Hill, North Carolina, United States

Childrens Hospital Medical Center

Cincinnati, Ohio, United States

Cleveland Clinic Childrens Outpatient Center

Cleveland, Ohio, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

St Christophers Hospital For Children

Philadelphia, Pennsylvania, United States

Prisma Health Pediatric Endocrinology

Columbia, South Carolina, United States

Prisma Health Midlands

Greenville, South Carolina, United States

Research Institute of Dallas

Dallas, Texas, United States

Texas Childrens Hospital

Houston, Texas, United States

UT Health Houston

Houston, Texas, United States

University of Utah

Salt Lake City, Utah, United States

Seattle Children's Hospital

Seattle, Washington, United States

Children's Wisconsin - Milwaukee Campus

Milwaukee, Wisconsin, United States

Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

Buenos Aires, Argentina

Centro de Investigaciones Médicas Mar del Plata

Mar del Plata, Argentina

INECO Neurociencias Oroño

Rosario, Argentina

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

San Miguel de Tucumán, Argentina

Go Centro Medico San Nicolás

San Nicolás, Argentina

Centro de Estudios de Investigacion Metabolicos y Cardiovasculares

Ciudad Madero, Mexico

Hospital Angeles (HA) - Puebla

Puebla City, Mexico

Clínica Cemain

Tampico, Mexico

Innovacion y Desarrollo de Estrategias en Salud SA de CV

Tlalpan, Mexico

Arké SMO S.A de C.V

Veracruz, Mexico

View Full Details on ClinicalTrials.gov

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NCT06739122

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