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 (30) 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
NOT_YET_RECRUITING
Tucson
California
Division of Endocrinology, Diabetes, and Metabolism
NOT_YET_RECRUITING
Los Angeles
UCLA Mattel Children's Hospital
NOT_YET_RECRUITING
Los Angeles
University of California, San Francisco
RECRUITING
San Francisco
Connecticut
Yale Diabetes Research
NOT_YET_RECRUITING
New Haven
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
NOT_YET_RECRUITING
Orlando
D&H Tamarac Research Center, LLC
RECRUITING
Tamarac
Georgia
Children's Healthcare of Atlanta - Center for Advanced Pediatrics
RECRUITING
Atlanta
Centricity Research Columbus Endocrinology
RECRUITING
Columbus
Idaho
St. Luke's Children's Endocrinology and Diabetes
NOT_YET_RECRUITING
Boise
Illinois
University of Illinois at Chicago
RECRUITING
Chicago
Kentucky
Norton Children's Endocrinology
NOT_YET_RECRUITING
Louisville
Mississippi
University of Mississippi Medical Center
NOT_YET_RECRUITING
Jackson
North Carolina
UNC Children's Hospital
NOT_YET_RECRUITING
Chapel Hill
New Mexico
University of New Mexico Hospital
NOT_YET_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
NOT_YET_RECRUITING
Cincinnati
Cleveland Clinic Childrens Outpatient Center
NOT_YET_RECRUITING
Cleveland
Oklahoma
University of Oklahoma Health Sciences Center
NOT_YET_RECRUITING
Oklahoma City
Pennsylvania
Children's Hospital of Philadelphia
NOT_YET_RECRUITING
Philadelphia
South Carolina
Prisma Health Pediatric Endocrinology
RECRUITING
Columbia
Texas
Texas Childrens Hospital
NOT_YET_RECRUITING
Houston
Utah
University of Utah
NOT_YET_RECRUITING
Salt Lake City
Washington
Seattle Children's Hospital
NOT_YET_RECRUITING
Seattle
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: 2026-07
Participants
Target number of participants: 55
Treatments
Experimental: Dulaglutide
Participants will receive dulaglutide subcutaneously (SC)
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company