Clinical trial NCT02963766: A Study of Dulaglutide (LY2189265) in Children and Adolescents With Type 2 Diabetes
Official title: A Randomized, Double-Blind Study With an Open-Label Extension Comparing the Effect of Once-Weekly Dulaglutide With Placebo in Pediatric Patients With Type 2 Diabetes Mellitus (AWARD-PEDS: Assessment of Weekly AdministRation of LY2189265 in Diabetes-PEDiatric Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Keywords: Pediatrics
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2016-11-15
Enrollment: 154
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Have type 2 diabetes, treated with diet and exercise, with or without metformin and/or basal insulin. Metformin and/or basal insulin dose must be stable for at least 8 weeks prior to study screening.
* 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:

* Known type 1 diabetes, or positive GAD65 or IA2 antibodies, or history of diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome.
* 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.

Primary outcomes:
measure: Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses) at Week 26
timeFrame: Baseline, Week 26
Secondary outcomes:
measure: Change From Baseline in HbA1c (Individual Doses) at Week 26
timeFrame: Baseline, Week 26
measure: Change From Baseline in Fasting Blood Glucose (FBG) at Week 26
timeFrame: Baseline, Week 26
measure: Percentage of Participants With HbA1c ≤7.0%
timeFrame: Week 26
measure: Change From Baseline in Body Mass Index (BMI) at Week 26
timeFrame: Baseline, Week 26
measure: Percentage of Participants With Self-Reported Events of Hypoglycemia
timeFrame: Week 26
measure: Percentage of Participants Requiring Rescue for Severe, Persistent Hyperglycemia
timeFrame: Week 26
measure: Number of Participants With Adjudicated Pancreatitis
timeFrame: Week 26
measure: Change From Baseline in Pancreatic Enzymes at Week 26
timeFrame: Baseline, Week 26
measure: Number of Participants With Thyroid Treatment-Emergent Adverse Events
timeFrame: Week 26
measure: Change From Baseline in Serum Calcitonin at Week 26
timeFrame: Baseline, Week 26
measure: Percentage of Participants With Allergic, Hypersensitivity Reactions
timeFrame: Week 26
measure: Percentage of Participants With Injection Site Reactions
timeFrame: Week 26
measure: Number of Participants With Anti-Dulaglutide Antibodies
timeFrame: Baseline through Week 56
measure: Pharmacokinetics (PK): Maximum Concentration of Dulaglutide at Steady-state (Cmax,ss)
timeFrame: Week 9: pre-dose,1 to 12 hours post dose and 24 to 96 hours post dose; Week 13: predose and 1 to 12 hours post dose; Week 26: predose; Week 39: up to 2 days postdose; Week 52 and Week 56: PK sample can be taken at any time during the visit
measure: PK: Area Under the Concentration Time Curve Over a 1-week Interval of Dulaglutide at Steady-State [AUC(0-168)ss]
timeFrame: Week 9: pre-dose,1 to 12 hours post dose and 24 to 96 hours post dose; Week 13: predose and 1 to 12 hours post dose; Week 26: predose; Week 39: up to 2 days postdose; Week 52 and Week 56: PK sample can be taken at any time during the visit
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham
state: Alabama
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Anaheim
country: United States
facility: Advanced Research Center
state: California
city: Los Angeles
country: United States
facility: Division of Endocrinology, Diabetes, and Metabolism
state: California
city: Orange
country: United States
facility: Childrens Hospital of Orange County
state: California
city: Sacramento
country: United States
facility: Center of Excellence in Diabetes & Endocrinology
state: California
city: San Diego
country: United States
facility: Rady Childrens Hospital - San Diego
state: California
city: San Jose
country: United States
facility: JC Cabaccan
state: California
city: Vallejo
country: United States
facility: Touro University
state: California
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Orlando
country: United States
facility: Florida Center for Endocrinology & Metabolism
state: Florida
city: Boise
country: United States
facility: St. Luke's Regional Medical Center
state: Idaho
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Health Hospital
state: Indiana
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
city: Greenville
country: United States
facility: ECU Pediatric Specialty Care
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Childrens Hospital Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Childrens Hospital of Pittsburgh
state: Pennsylvania
city: Seattle
country: United States
facility: Seattle Children's Hospital Research Foundation
state: Washington
city: Tacoma
country: United States
facility: Multicare Health System
state: Washington
city: Charleston
country: United States
facility: CAMC Institute
state: West Virginia
city: Porto Alegre
country: Brazil
facility: Centro de Pesquisas em Diabetes
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Instituto da Criança com Diabetes
state: Rio Grande Do Sul
city: Rio de Janeiro
country: Brazil
facility: Instituto Estadual de Diabetes e Endocrinologia
state: RJ
city: Campinas
country: Brazil
facility: Hospital PUC-CAMPINAS
state: Sao Paulo
city: São Paulo
country: Brazil
facility: CPCLIN
state: SP
city: São Paulo
country: Brazil
facility: Hospital da Clinicas da Faculdade de Medicina da USP
state: SP
city: Ribeirão Preto
country: Brazil
facility: Hospital das Clinicas da FMRP
state: São Paulo
city: São Paulo
country: Brazil
facility: UNIFESP - Escola Paulista de Medicina
city: Le Kremlin Bicetre
country: France
facility: Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
city: Paris
country: France
facility: Hopital Robert Debre
city: Mayen
country: Germany
facility: Praxis Dr. med. Landers
state: Rheinland-Pfalz
city: Sankt Ingbert
country: Germany
facility: Zentrum für klinische Studien
state: Saarland
city: Oldenburg in Holstein
country: Germany
facility: RED-Institut GmbH
state: Schleswig Holstein
city: Budapest
country: Hungary
facility: Heim Pal Gyermekkorhaz
city: New Delhi
country: India
facility: Sir Ganga Ram Hospital
state: Delhi
city: Ahmedabad
country: India
facility: Dr Jivraj Mehta Smarak Health Foundation Bakeri Medical Research Centre
state: Gujarat
city: Bangalore
country: India
facility: Manipal Hospital
state: Karmnataka
city: Bangalore
country: India
facility: M S Ramaiah Medical College Hospital
state: Karnataka
city: Pune
country: India
facility: Deenanath Mangeshkar Hospital & Research Centre
state: Maharashtra
city: Chandigarh
country: India
facility: Post Graduate Institute of Medical Education & Research
state: Punjab
city: Varanasi
country: India
facility: Banaras Hindu University - BHU
state: Uttar Pradesh
city: Kolkata
country: India
facility: Park Clinic
state: West Bengal
city: Kolkata
country: India
facility: Apollo Gleneagles Hospitals Kolkata
state: West Bengal
city: Mexico City
country: Mexico
facility: Health Pharma Professional Research, S.A. de C.V.
state: Federal District
city: Zapopan
country: Mexico
facility: Centro de Inv. Medica de Occidente, SC
state: Jalisco
city: Monterrey
country: Mexico
facility: Centro Medico San Francisco
state: Nuevo Leon
city: Tampico
country: Mexico
facility: Cli-nica Hospital Cemain
state: Tamaulipas
city: Puebla
country: Mexico
facility: Hospital Angeles Puebla
city: Veracruz
country: Mexico
facility: Arke Estudios Clinicos S.A. de C.V.
city: Bayamon
country: Puerto Rico
facility: Centro de Diabetes y Endocrinologia Pediatrica de PR
city: Riyadh
country: Saudi Arabia
facility: King Saud University Hospital
city: Riyadh
country: Saudi Arabia
facility: King Salman bin Abdulaziz Hospital - Diabetic Center
city: Ankara
country: Turkey
facility: Ankara University Medicine Hospital
state: Mamak
city: Ankara
country: Turkey
facility: Sami Ulus Education & Research Hospital
city: Duzce
country: Turkey
facility: Duzce University Medical Faculty
city: Samsun
country: Turkey
facility: Ondokuz Mayis University Medical Faculty
city: Liverpool
country: United Kingdom
facility: Alder Hey Children's Hospital
state: Lancashire
city: Leeds
country: United Kingdom
facility: St James's University Hospital
state: West Yorkshire
Study officials:
affiliation: Eli Lilly and Company
name: 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
References:
citation: 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.