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
Status: Recruiting
Location: See all (51) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 17
Healthy Volunteers: f
View:
• 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
Locations
United States
Arkansas
Arkansas Childrens Hospital
RECRUITING
Little Rock
Arizona
University of Arizona
RECRUITING
Tucson
California
Division of Endocrinology, Diabetes, and Metabolism
RECRUITING
Los Angeles
UCLA Mattel Children's Hospital
RECRUITING
Los Angeles
University of California, San Francisco
RECRUITING
San Francisco
Colorado
Children's Hospital of Colorado
NOT_YET_RECRUITING
Denver
Connecticut
Yale Diabetes Research
RECRUITING
New Haven
Washington, D.c.
Children's National Medical Center
NOT_YET_RECRUITING
Washington D.c.
Emerson Clinical Research Institute
RECRUITING
Washington D.c.
Florida
Nemours Children's Health
RECRUITING
Jacksonville
D&H National Research Centers, Inc
RECRUITING
Miami
AdventHealth Orlando
RECRUITING
Orlando
D&H Tamarac Research Center, LLC
RECRUITING
Tamarac
University of South Florida
NOT_YET_RECRUITING
Tampa
Georgia
Children's Healthcare of Atlanta - Center for Advanced Pediatrics
RECRUITING
Atlanta
Centricity Research Columbus Endocrinology
RECRUITING
Columbus
Iowa
University of Iowa Stead Family Children's Hospitals
NOT_YET_RECRUITING
Iowa City
Idaho
St. Luke's Children's Endocrinology and Diabetes
RECRUITING
Boise
Illinois
University of Illinois at Chicago
RECRUITING
Chicago
Indiana
Center for Diabetes and Metabolic Diseases Indiana University
NOT_YET_RECRUITING
Indianapolis
Kentucky
Norton Children's Endocrinology
RECRUITING
Louisville
Maryland
Johns Hopkins University School of Medicine
NOT_YET_RECRUITING
Baltimore
Mississippi
University of Mississippi Medical Center
RECRUITING
Jackson
North Carolina
UNC Children's Hospital
RECRUITING
Chapel Hill
New Mexico
University of New Mexico Hospital
RECRUITING
Albuquerque
New York
WBMD Pediatrics
RECRUITING
Buffalo
Cohen Children's Medical Center Division of Pediatric Endocrinology
RECRUITING
Hyde Park
SUNY Upstate Medical University
RECRUITING
Syracuse
Ohio
Childrens Hospital Medical Center
RECRUITING
Cincinnati
Cleveland Clinic Childrens Outpatient Center
RECRUITING
Cleveland
Oklahoma
University of Oklahoma Health Sciences Center
RECRUITING
Oklahoma City
Pennsylvania
Children's Hospital of Philadelphia
RECRUITING
Philadelphia
St Christophers Hospital For Children
NOT_YET_RECRUITING
Philadelphia
South Carolina
Prisma Health Pediatric Endocrinology
RECRUITING
Columbia
Prisma Health Midlands
NOT_YET_RECRUITING
Greenville
Texas
Research Institute of Dallas
NOT_YET_RECRUITING
Dallas
Texas Childrens Hospital
RECRUITING
Houston
UT Health Houston
NOT_YET_RECRUITING
Houston
Utah
University of Utah
RECRUITING
Salt Lake City
Washington
Seattle Children's Hospital
RECRUITING
Seattle
Wisconsin
Children's Wisconsin - Milwaukee Campus
NOT_YET_RECRUITING
Milwaukee
Other Locations
Argentina
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
NOT_YET_RECRUITING
Buenos Aires
Centro de Investigaciones Médicas Mar del Plata
NOT_YET_RECRUITING
Mar Del Plata
INECO Neurociencias Oroño
NOT_YET_RECRUITING
Rosario
Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L
NOT_YET_RECRUITING
San Miguel De Tucumán
Go Centro Medico San Nicolás
NOT_YET_RECRUITING
San Nicolás
Mexico
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares
NOT_YET_RECRUITING
Ciudad Madero
Hospital Angeles (HA) - Puebla
NOT_YET_RECRUITING
Puebla City
Clínica Cemain
NOT_YET_RECRUITING
Tampico
Innovacion y Desarrollo de Estrategias en Salud SA de CV
NOT_YET_RECRUITING
Tlalpan
Arké SMO S.A de C.V
NOT_YET_RECRUITING
Veracruz
Contact Information
Primary
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
1-317-615-4559
Backup
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Time Frame
Start Date: 2025-01-10
Estimated Completion Date: 2027-12
Participants
Target number of participants: 55
Treatments
Experimental: Dulaglutide
Participants will receive dulaglutide subcutaneously (SC)
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company