A Study of Dulaglutide (LY2189265) in Children and Adolescents With Type 2 Diabetes
NCT ID: NCT02963766
Last Updated: 2022-07-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
154 participants
INTERVENTIONAL
2016-12-29
2022-01-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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).
Dulaglutide
Administered SC
Placebo
Administered SC
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.
Dulaglutide
Administered SC
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.
Dulaglutide
Administered SC
Interventions
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Dulaglutide
Administered SC
Placebo
Administered SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have HbA1c \>6.5% to ≤11% at screening visit. If newly diagnosed and not on medicine for diabetes, HbA1c must be between \>6.5 % to ≤9%.
* Have a BMI (body mass index) \>85 percentile for age, gender and body weight ≥50 kilograms (110 pounds).
Exclusion Criteria
* A history of, or at risk for pancreatitis.
* Self or family history of Multiple Endocrine Neoplasia (MEN) type 2A or B, thyroid C-cell hyperplasia or medullary thyroid cancer, or a blood calcitonin result ≥20 picograms per milliliter (pg/ml) at screening.
* A systolic blood pressure of ≥160 millimeters of mercury (mmHg) or diastolic ≥100 mmHg.
* Active or treated cancer.
* A blood disorder where an accurate HbA1c may not be obtainable.
* A female of childbearing age, sexually active and not on birth control.
* Pregnant or plan to be pregnant during the study, or breastfeeding.
* Taking any diabetic medication other than metformin or basal insulin and have not stopped it 3 months prior to the screening visit (6 weeks for bolus or mealtime insulin).
* Have taken oral steroids within the last 60 days or more than 20 days use within the past year or 1000 micrograms fluticasone propionate per day.
* Using prescription weight loss medications in the last 30 days, or plan to use.
* Taking psychiatric medications for depression or illness or attention deficit hyperactivity disorder (ADHD) if, the doses has changed within the last 3 months.
10 Years
17 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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University of Alabama Birmingham
Birmingham, Alabama, United States
University of Arizona
Tucson, Arizona, United States
Advanced Research Center
Anaheim, California, United States
Division of Endocrinology, Diabetes, and Metabolism
Los Angeles, California, United States
Childrens Hospital of Orange County
Orange, California, United States
Center of Excellence in Diabetes & Endocrinology
Sacramento, California, United States
Rady Childrens Hospital - San Diego
San Diego, California, United States
JC Cabaccan
San Jose, California, United States
Touro University
Vallejo, California, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Florida Center for Endocrinology & Metabolism
Orlando, Florida, United States
St. Luke's Regional Medical Center
Boise, Idaho, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Indiana University Health Hospital
Indianapolis, Indiana, United States
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
ECU Pediatric Specialty Care
Greenville, North Carolina, United States
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Childrens Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Seattle Children's Hospital Research Foundation
Seattle, Washington, United States
Multicare Health System
Tacoma, Washington, United States
CAMC Institute
Charleston, West Virginia, United States
Instituto Estadual de Diabetes e Endocrinologia
Rio de Janeiro, Rio de Janeiro, Brazil
Centro de Pesquisas em Diabetes
Porto Alegre, Rio Grande do Sul, Brazil
Instituto da Criança com Diabetes
Porto Alegre, Rio Grande do Sul, Brazil
Hospital PUC-CAMPINAS
Campinas, São Paulo, Brazil
Hospital das Clinicas da FMRP
Ribeirão Preto, São Paulo, Brazil
CPCLIN
São Paulo, São Paulo, Brazil
Hospital da Clinicas da Faculdade de Medicina da USP
São Paulo, São Paulo, Brazil
UNIFESP - Escola Paulista de Medicina
São Paulo, , Brazil
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
Le Kremlin-Bicêtre, , France
Hopital Robert Debre
Paris, , France
Praxis Dr. med. Landers
Mayen, Rhineland-Palatinate, Germany
Zentrum für klinische Studien
Sankt Ingbert, Saarland, Germany
RED-Institut GmbH
Oldenburg in Holstein, Schleswig-Holstein, Germany
Heim Pal Gyermekkorhaz
Budapest, , Hungary
Dr Jivraj Mehta Smarak Health Foundation Bakeri Medical Research Centre
Ahmedabad, Gujarat, India
Manipal Hospital
Bangalore, Karmnataka, India
M S Ramaiah Medical College Hospital
Bangalore, Karnataka, India
Deenanath Mangeshkar Hospital & Research Centre
Pune, Maharashtra, India
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, India
Post Graduate Institute of Medical Education & Research
Chandigarh, Punjab, India
Banaras Hindu University - BHU
Varanasi, Uttar Pradesh, India
Park Clinic
Kolkata, West Bengal, India
Apollo Gleneagles Hospitals Kolkata
Kolkata, West Bengal, India
Health Pharma Professional Research, S.A. de C.V.
Mexico City, Federal District, Mexico
Centro de Inv. Medica de Occidente, SC
Zapopan, Jalisco, Mexico
Centro Medico San Francisco
Monterrey, Nuevo León, Mexico
Cli-nica Hospital Cemain
Tampico, Tamaulipas, Mexico
Hospital Angeles Puebla
Puebla City, , Mexico
Arke Estudios Clinicos S.A. de C.V.
Veracruz, , Mexico
Centro de Diabetes y Endocrinologia Pediatrica de PR
Bayamón, PR, Puerto Rico
King Saud University Hospital
Riyadh, , Saudi Arabia
King Salman bin Abdulaziz Hospital - Diabetic Center
Riyadh, , Saudi Arabia
Ankara University Medicine Hospital
Ankara, Mamak, Turkey (Türkiye)
Sami Ulus Education & Research Hospital
Ankara, , Turkey (Türkiye)
Duzce University Medical Faculty
Düzce, , Turkey (Türkiye)
Ondokuz Mayis University Medical Faculty
Samsun, , Turkey (Türkiye)
Alder Hey Children's Hospital
Liverpool, Lancashire, United Kingdom
St James's University Hospital
Leeds, West Yorkshire, United Kingdom
Countries
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References
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Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2.
Arslanian SA, Hannon T, Zeitler P, Chao LC, Boucher-Berry C, Barrientos-Perez M, Bismuth E, Dib S, Cho JI, Cox D; AWARD-PEDS Investigators. Once-Weekly Dulaglutide for the Treatment of Youths with Type 2 Diabetes. N Engl J Med. 2022 Aug 4;387(5):433-443. doi: 10.1056/NEJMoa2204601. Epub 2022 Jun 4.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Study of Dulaglutide (LY2189265) in Children and Adolescents With Type 2 Diabetes (AWARD-PEDS)
Other Identifiers
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H9X-MC-GBGC
Identifier Type: OTHER
Identifier Source: secondary_id
2016-000361-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
14171
Identifier Type: -
Identifier Source: org_study_id
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