A Study of Dulaglutide (LY2189265) 3.0 mg and 4.5 mg in Pediatric Participants With Type 2 Diabetes Mellitus (AWARD-PEDS PLUS)
Part of paid clinical trials in Tucson, Arizona.
- Sponsor
- Eli Lilly and Company
- Study ID
- NCT06739122
- Phase
- PHASE3
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 10 Years - 17 Years
- Healthy Volunteers
- Not accepted
Interventions
- Dulaglutide — DRUGAdministered SC
Study Details
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.
Key Dates
- Start date
- Jan 10, 2025
- Status verified
- May 2026
- Primary completion
- Dec 31, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 55 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: DulaglutideParticipants will receive dulaglutide subcutaneously (SC)
Primary Outcome Measure
Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration [ Time Frame: Baseline through Week 26 ]
Central Contacts
- Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or1-317-615-4559
- Physicians interested in becoming principal investigators please contact
Locations (41)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Arizona | Tucson | Arizona | 85724 | 520-626-3197 Sunil Sinha (PRINCIPAL_INVESTIGATOR) |
| Arkansas Childrens Hospital | Little Rock | Arkansas | 72202-3500 | 505-272-5551 Jon Oden (PRINCIPAL_INVESTIGATOR) |
| Division of Endocrinology, Diabetes, and Metabolism | Los Angeles | California | 90027 | Lily Chao (PRINCIPAL_INVESTIGATOR) |
| UCLA Mattel Children's Hospital | Los Angeles | California | 90095 | 310-203-7631 Vibha Singhal (PRINCIPAL_INVESTIGATOR) |
| University of California, San Francisco | San Francisco | California | 94158 | 415-514-6234 Shylaja Sirinivasan (PRINCIPAL_INVESTIGATOR) |
| Children's Hospital of Colorado | Denver | Colorado | 80045 | 20-777-3618 Melanie Cree (PRINCIPAL_INVESTIGATOR) |
| Yale Diabetes Research | New Haven | Connecticut | 06511 | 203-737-7177 Michelle Van Name (PRINCIPAL_INVESTIGATOR) |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | 888-884-2327 Shideh Majidi (PRINCIPAL_INVESTIGATOR) |
| Emerson Clinical Research Institute | Washington D.C. | District of Columbia | 20009 | 202-239-0777 Julia Pineda (PRINCIPAL_INVESTIGATOR) |
| Nemours Children's Health | Jacksonville | Florida | 32207 | Camila Pereira-Eshraghi (PRINCIPAL_INVESTIGATOR) |
| D&H National Research Centers, Inc | Miami | Florida | 33155 | 786-375-6210 Yanetsi Flores Landa (PRINCIPAL_INVESTIGATOR) |
| AdventHealth Orlando | Orlando | Florida | 32803 | 407-896-2901 Konda Reddy (PRINCIPAL_INVESTIGATOR) |
| D&H Tamarac Research Center, LLC | Tamarac | Florida | 33321 | 786-375-6210 Helena Gaviria (PRINCIPAL_INVESTIGATOR) |
| University of South Florida | Tampa | Florida | 33612 | Henry Rodriguez (PRINCIPAL_INVESTIGATOR) |
| Children's Healthcare of Atlanta - Center for Advanced Pediatrics | Atlanta | Georgia | 30329 | Daniel Hsia (PRINCIPAL_INVESTIGATOR) |
| Centricity Research Columbus Endocrinology | Columbus | Georgia | 31904 | Steven Leichter (PRINCIPAL_INVESTIGATOR) |
| St. Luke's Children's Endocrinology and Diabetes | Boise | Idaho | 83712 | 208-381-7340 Daniel Flynn (PRINCIPAL_INVESTIGATOR) |
| University of Illinois at Chicago | Chicago | Illinois | 60612 | 312-307-9385 Roxana Aguirre Castaneda (PRINCIPAL_INVESTIGATOR) |
| Center for Diabetes and Metabolic Diseases Indiana University | Indianapolis | Indiana | 46202 | 317-278-9699 Tamara Hannon (PRINCIPAL_INVESTIGATOR) |
| University of Iowa Stead Family Children's Hospitals | Iowa City | Iowa | 52242 | 319-335-0077 Michael Tansey (PRINCIPAL_INVESTIGATOR) |
| Norton Children's Endocrinology | Louisville | Kentucky | 40202 | 502-588-3400 Sara Watson (PRINCIPAL_INVESTIGATOR) |
| Johns Hopkins University School of Medicine | Baltimore | Maryland | 21287 | 443-287-9032 Risa Wolf (PRINCIPAL_INVESTIGATOR) |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | 601-815-5000 Nazmin Dixit (PRINCIPAL_INVESTIGATOR) |
| University of New Mexico Hospital | Albuquerque | New Mexico | 87106 | 505-272-3073 Michelle Hutchison (PRINCIPAL_INVESTIGATOR) |
| WBMD Pediatrics | Buffalo | New York | 14203 | Kathleen Bethin (PRINCIPAL_INVESTIGATOR) |
| Cohen Children's Medical Center Division of Pediatric Endocrinology | Hyde Park | New York | 11042 | 516-472-3750 Benjamin Nwosu (PRINCIPAL_INVESTIGATOR) |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | 315-464-9006 David Hansen (PRINCIPAL_INVESTIGATOR) |
| UNC Children's Hospital | Chapel Hill | North Carolina | 27514 | 919-966-2333 Nina Jain (PRINCIPAL_INVESTIGATOR) |
| Childrens Hospital Medical Center | Cincinnati | Ohio | 45229 | 513-803-7274 Ryan Brady (PRINCIPAL_INVESTIGATOR) |
| Cleveland Clinic Childrens Outpatient Center | Cleveland | Ohio | 44106 | 216-636-2828 Roy Kim (PRINCIPAL_INVESTIGATOR) |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | 405-271-6764 Jeanie Tryggestad (PRINCIPAL_INVESTIGATOR) |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | Steven Willi (PRINCIPAL_INVESTIGATOR) |
| St Christophers Hospital For Children | Philadelphia | Pennsylvania | 19134 | 215-427-7911 Elizabeth Suarez (PRINCIPAL_INVESTIGATOR) |
| Prisma Health Pediatric Endocrinology | Columbia | South Carolina | 29203 | 803-434-7990 Alison Lunsford (PRINCIPAL_INVESTIGATOR) |
| Prisma Health Midlands | Greenville | South Carolina | 29615 | 864-454-5656 Elaine Apperson (PRINCIPAL_INVESTIGATOR) |
| Research Institute of Dallas | Dallas | Texas | 75231 | 248-817-4331 Heidi Shea (PRINCIPAL_INVESTIGATOR) |
| Texas Childrens Hospital | Houston | Texas | 77030 | Siripoom McKay (PRINCIPAL_INVESTIGATOR) |
| UT Health Houston | Houston | Texas | 77030 | 713-500-7257 Anvi Shah (PRINCIPAL_INVESTIGATOR) |
| University of Utah | Salt Lake City | Utah | 84112 | Jacqueline Chan (PRINCIPAL_INVESTIGATOR) |
| Seattle Children's Hospital | Seattle | Washington | 98105 | 206-987-3897 Petter Bjornstand (PRINCIPAL_INVESTIGATOR) |
| Children's Wisconsin - Milwaukee Campus | Milwaukee | Wisconsin | 53226 | 414-955-8486 Susanne Cabrera (PRINCIPAL_INVESTIGATOR) |
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