A Study of Dulaglutide (LY2189265) in Children and Adolescents With Type 2 Diabetes

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Eli Lilly and Company
Study ID
NCT02963766
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
10 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Dulaglutide — DRUG
    Administered SC
  • Placebo — DRUG
    Administered SC

Study Details

The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of the study drug dulaglutide compared to placebo in pediatric participants with type 2 diabetes. The study duration is approximately 60 weeks.

Key Dates

Start date
Dec 29, 2016
Status verified
Jun 2022
Primary completion
Jun 12, 2021
Completion
Jan 12, 2022

Study Design

Enrollment
154 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Placebo/0.75 milligram (mg) Dulaglutide
    Participants received placebo administered subcutaneously (SC) for 26 weeks during the double-blind period and open-label 0.75 mg/week dulaglutide for 26 weeks during the Open Label Extension (OLE).
  • Experimental: 0.75 mg Dulaglutide
    Participants received 0.75 mg/week dulaglutide administered SC for 26 weeks during the double-blind period and open-label 0.75 mg/week for 26 weeks during the OLE.
  • Experimental: 1.5 mg Dulaglutide
    Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks during the double-blind period and open-label 1.5 mg/week for 26 weeks during the OLE.

Primary Outcome Measure

Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses) at Week 26 [ Time Frame: Baseline, Week 26 ]

Locations (23)

FacilityCityStateZIPSite coordinators
University of Alabama BirminghamBirminghamAlabama35233-
University of ArizonaTucsonArizona85724-
Advanced Research CenterAnaheimCalifornia92805-
Division of Endocrinology, Diabetes, and MetabolismLos AngelesCalifornia90027-
Childrens Hospital of Orange CountyOrangeCalifornia92868-
Center of Excellence in Diabetes & EndocrinologySacramentoCalifornia95821-
Rady Childrens Hospital - San DiegoSan DiegoCalifornia92123-
JC CabaccanSan JoseCalifornia95148-
Touro UniversityVallejoCalifornia94592-
Children's National Medical CenterWashington D.C.District of Columbia20010-
Florida Center for Endocrinology & MetabolismOrlandoFlorida32803-
St. Luke's Regional Medical CenterBoiseIdaho83712-
University of Illinois at ChicagoChicagoIllinois60612-
Indiana University Health HospitalIndianapolisIndiana46202-
Pennington Biomedical Research CenterBaton RougeLouisiana70808-4124-
Children's Mercy HospitalKansas CityMissouri64108-
ECU Pediatric Specialty CareGreenvilleNorth Carolina27834-
Cincinnati Childrens Hospital Medical CenterCincinnatiOhio45229-
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-
Childrens Hospital of PittsburghPittsburghPennsylvania15224-
Seattle Children's Hospital Research FoundationSeattleWashington98105-
Multicare Health SystemTacomaWashington98405-
CAMC InstituteCharlestonWest Virginia25302-

Find similar trials in Birmingham, AL

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
University of Alabama Birmingham· Birmingham, ALUniversity of Arizona· Tucson, AZAdvanced Research Center· Anaheim, CADivision of Endocrinology, Diabetes, and Metabolism· Los Angeles, CAChildrens Hospital of Orange County· Orange, CACenter of Excellence in Diabetes & Endocrinology· Sacramento, CA

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