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

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: Dulaglutide
    Participants 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) or
    1-317-615-4559
  • Physicians interested in becoming principal investigators please contact

Locations (41)

FacilityCityStateZIPSite coordinators
University of ArizonaTucsonArizona85724
520-626-3197
Sunil Sinha (PRINCIPAL_INVESTIGATOR)
Arkansas Childrens HospitalLittle RockArkansas72202-3500
505-272-5551
Jon Oden (PRINCIPAL_INVESTIGATOR)
Division of Endocrinology, Diabetes, and MetabolismLos AngelesCalifornia90027
Lily Chao (PRINCIPAL_INVESTIGATOR)
UCLA Mattel Children's HospitalLos AngelesCalifornia90095
310-203-7631
Vibha Singhal (PRINCIPAL_INVESTIGATOR)
University of California, San FranciscoSan FranciscoCalifornia94158
415-514-6234
Shylaja Sirinivasan (PRINCIPAL_INVESTIGATOR)
Children's Hospital of ColoradoDenverColorado80045
20-777-3618
Melanie Cree (PRINCIPAL_INVESTIGATOR)
Yale Diabetes ResearchNew HavenConnecticut06511
203-737-7177
Michelle Van Name (PRINCIPAL_INVESTIGATOR)
Children's National Medical CenterWashington D.C.District of Columbia20010
888-884-2327
Shideh Majidi (PRINCIPAL_INVESTIGATOR)
Emerson Clinical Research InstituteWashington D.C.District of Columbia20009
202-239-0777
Julia Pineda (PRINCIPAL_INVESTIGATOR)
Nemours Children's HealthJacksonvilleFlorida32207
Camila Pereira-Eshraghi (PRINCIPAL_INVESTIGATOR)
D&H National Research Centers, IncMiamiFlorida33155
786-375-6210
Yanetsi Flores Landa (PRINCIPAL_INVESTIGATOR)
AdventHealth OrlandoOrlandoFlorida32803
407-896-2901
Konda Reddy (PRINCIPAL_INVESTIGATOR)
D&H Tamarac Research Center, LLCTamaracFlorida33321
786-375-6210
Helena Gaviria (PRINCIPAL_INVESTIGATOR)
University of South FloridaTampaFlorida33612
Henry Rodriguez (PRINCIPAL_INVESTIGATOR)
Children's Healthcare of Atlanta - Center for Advanced PediatricsAtlantaGeorgia30329
Daniel Hsia (PRINCIPAL_INVESTIGATOR)
Centricity Research Columbus EndocrinologyColumbusGeorgia31904
Steven Leichter (PRINCIPAL_INVESTIGATOR)
St. Luke's Children's Endocrinology and DiabetesBoiseIdaho83712
208-381-7340
Daniel Flynn (PRINCIPAL_INVESTIGATOR)
University of Illinois at ChicagoChicagoIllinois60612
312-307-9385
Roxana Aguirre Castaneda (PRINCIPAL_INVESTIGATOR)
Center for Diabetes and Metabolic Diseases Indiana UniversityIndianapolisIndiana46202
317-278-9699
Tamara Hannon (PRINCIPAL_INVESTIGATOR)
University of Iowa Stead Family Children's HospitalsIowa CityIowa52242
319-335-0077
Michael Tansey (PRINCIPAL_INVESTIGATOR)
Norton Children's EndocrinologyLouisvilleKentucky40202
502-588-3400
Sara Watson (PRINCIPAL_INVESTIGATOR)
Johns Hopkins University School of MedicineBaltimoreMaryland21287
443-287-9032
Risa Wolf (PRINCIPAL_INVESTIGATOR)
University of Mississippi Medical CenterJacksonMississippi39216
601-815-5000
Nazmin Dixit (PRINCIPAL_INVESTIGATOR)
University of New Mexico HospitalAlbuquerqueNew Mexico87106
505-272-3073
Michelle Hutchison (PRINCIPAL_INVESTIGATOR)
WBMD PediatricsBuffaloNew York14203
Kathleen Bethin (PRINCIPAL_INVESTIGATOR)
Cohen Children's Medical Center Division of Pediatric EndocrinologyHyde ParkNew York11042
516-472-3750
Benjamin Nwosu (PRINCIPAL_INVESTIGATOR)
SUNY Upstate Medical UniversitySyracuseNew York13210
315-464-9006
David Hansen (PRINCIPAL_INVESTIGATOR)
UNC Children's HospitalChapel HillNorth Carolina27514
919-966-2333
Nina Jain (PRINCIPAL_INVESTIGATOR)
Childrens Hospital Medical CenterCincinnatiOhio45229
513-803-7274
Ryan Brady (PRINCIPAL_INVESTIGATOR)
Cleveland Clinic Childrens Outpatient CenterClevelandOhio44106
216-636-2828
Roy Kim (PRINCIPAL_INVESTIGATOR)
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104
405-271-6764
Jeanie Tryggestad (PRINCIPAL_INVESTIGATOR)
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Steven Willi (PRINCIPAL_INVESTIGATOR)
St Christophers Hospital For ChildrenPhiladelphiaPennsylvania19134
215-427-7911
Elizabeth Suarez (PRINCIPAL_INVESTIGATOR)
Prisma Health Pediatric EndocrinologyColumbiaSouth Carolina29203
803-434-7990
Alison Lunsford (PRINCIPAL_INVESTIGATOR)
Prisma Health MidlandsGreenvilleSouth Carolina29615
864-454-5656
Elaine Apperson (PRINCIPAL_INVESTIGATOR)
Research Institute of DallasDallasTexas75231
248-817-4331
Heidi Shea (PRINCIPAL_INVESTIGATOR)
Texas Childrens HospitalHoustonTexas77030
Siripoom McKay (PRINCIPAL_INVESTIGATOR)
UT Health HoustonHoustonTexas77030
713-500-7257
Anvi Shah (PRINCIPAL_INVESTIGATOR)
University of UtahSalt Lake CityUtah84112
Jacqueline Chan (PRINCIPAL_INVESTIGATOR)
Seattle Children's HospitalSeattleWashington98105
206-987-3897
Petter Bjornstand (PRINCIPAL_INVESTIGATOR)
Children's Wisconsin - Milwaukee CampusMilwaukeeWisconsin53226
414-955-8486
Susanne Cabrera (PRINCIPAL_INVESTIGATOR)

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