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
2 other identifiers
interventional
55
3 countries
51
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 type-2-diabetes
Started Jan 2025
Longer than P75 for phase_3 type-2-diabetes
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 13, 2024
CompletedFirst Posted
Study publicly available on registry
December 18, 2024
CompletedStudy Start
First participant enrolled
January 10, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
April 20, 2026
April 1, 2026
2.9 years
December 13, 2024
April 17, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration
A summary of treatment emergent adverse events (TEAEs), SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Baseline through Week 26
Secondary Outcomes (7)
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Dulaglutide
Predose through Week 30
PK: Maximum Observed Concentration (Cmax) of Dulaglutide
Predose through Week 30
Change from Baseline in Hemoglobin A1c (HbA1c)
Baseline, Week 26
Percent Change from Baseline in Body Weight
Baseline, Week 26
Change from Baseline in Total Cholesterol
Baseline, Week 26
- +2 more secondary outcomes
Study Arms (1)
Dulaglutide
EXPERIMENTALParticipants will receive dulaglutide subcutaneously (SC)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (51)
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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Central Study Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 13, 2024
First Posted
December 18, 2024
Study Start
January 10, 2025
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
April 20, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.