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

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ClinicalTrials.gov Identifier: NCT02963766
Recruitment Status : Recruiting
First Posted : November 15, 2016
Last Update Posted : October 18, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Dulaglutide Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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)
Actual Study Start Date : December 29, 2016
Estimated Primary Completion Date : June 21, 2021
Estimated Study Completion Date : January 27, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Dulaglutide

Arm Intervention/treatment
Experimental: Dose 1 Dulaglutide
Dulaglutide given subcutaneously (SC).
Drug: Dulaglutide
Administered SC
Other Name: LY2189265

Experimental: Dose 2 Dulaglutide
Dulaglutide given SC.
Drug: Dulaglutide
Administered SC
Other Name: LY2189265

Placebo Comparator: Placebo
Placebo given SC.
Drug: Dulaglutide
Administered SC
Other Name: LY2189265

Drug: Placebo
Administered SC




Primary Outcome Measures :
  1. Change from Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, Week 26 ]

Secondary Outcome Measures :
  1. Change from Baseline in HbA1c (Individual Doses) [ Time Frame: Baseline, Week 26 ]
  2. Change from Baseline in Fasting Blood Glucose (FBG) [ Time Frame: Baseline, Week 26 ]
  3. Percentage of Participants with HbA1c ≤6.5% [ Time Frame: Week 26 ]
  4. Change from Baseline in Body Mass Index (BMI) [ Time Frame: Baseline, Week 26 ]
  5. Percentage of Participants with Self-Reported Events of Hypoglycemia [ Time Frame: Week 26 ]
  6. Percentage of Participants Requiring Rescue for Severe, Persistent Hyperglycemia [ Time Frame: Week 26 ]
  7. Number of Participants with Adjudicated Pancreatitis [ Time Frame: Week 26 ]
  8. Change from Baseline in Pancreatic Enzymes [ Time Frame: Baseline, Week 26 ]
  9. Number of Participants with Thyroid Treatment-Emergent Adverse Events [ Time Frame: Week 26 ]
  10. Change from Baseline in Serum Calcitonin [ Time Frame: Baseline, Week 26 ]
  11. Percentage of Participants with Allergic, Hypersensitivity and Injection Site Reactions [ Time Frame: Week 26 ]
  12. Number of Participants with Anti-Dulaglutide Antibodies [ Time Frame: Baseline through Week 56 ]
  13. Pharmacokinetics (PK): Maximum Concentration (Cmax) of Dulaglutide [ Time Frame: Week 13 through Week 56 ]
  14. PK: Area Under the Concentration Time Curve (AUC) of Dulaglutide [ Time Frame: Week 13 through Week 56 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 after taking diabetes medication.
  • 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 ≥100mmHg.
  • 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02963766


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

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Locations
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United States, Alabama
University of Alabama Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact    2059969569      
Principal Investigator: Mary Lauren Scott         
United States, Arizona
University of Arizona Recruiting
Tucson, Arizona, United States, 85724
Contact    520-626-6077      
Principal Investigator: Mark Wheeler         
United States, California
Advanced Research Center Recruiting
Anaheim, California, United States, 92805
Contact    714-999-6688      
Principal Investigator: Patrick Walsh         
Division of Endocrinology, Diabetes, and Metabolism Not yet recruiting
Los Angeles, California, United States, 90027
Contact    323-361-7116      
Principal Investigator: Lily Chao         
Childrens Hospital of Orange County Recruiting
Orange, California, United States, 92868
Contact    714-509-8634      
Principal Investigator: Nikta Forghani         
Center of Excellence in Diabetes & Endocrinology Recruiting
Sacramento, California, United States, 95821
Contact    916-426-1902      
Principal Investigator: Gnanagurudasan Prakasam         
Rady Childrens Hospital - San Diego Recruiting
San Diego, California, United States, 92123
Contact    858-966-8400      
Principal Investigator: Michael E Gottschalk         
JC Cabaccan Recruiting
San Jose, California, United States, 95148
Contact    408-223-7000      
Principal Investigator: Josel Cabaccan         
Touro University Recruiting
Vallejo, California, United States, 94592
Contact    707-638-6969      
Principal Investigator: Jay Shubrook         
United States, District of Columbia
Children's National Medical Center Not yet recruiting
Washington, District of Columbia, United States, 20010
Contact    2024761403      
Principal Investigator: Doris Elizabeth Estrada         
United States, Florida
Nickalus Children's Hospital Research Institute Recruiting
Miami, Florida, United States, 33155
Contact    786-624-2854      
Principal Investigator: Luis E. Gonzalez-Mendoza         
Florida Center for Endocrinology & Metabolism Recruiting
Orlando, Florida, United States, 32803
Contact    407-896-2901      
Principal Investigator: Konda Reddy         
United States, Idaho
St. Luke's Regional Medical Center Recruiting
Boise, Idaho, United States, 83712
Contact    208-381-8923      
Principal Investigator: Daniel Flynn         
United States, Illinois
University of Illinois at Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact    312-996-1795      
Principal Investigator: Claudia Boucher-Berry         
United States, Indiana
Indiana University Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact    317-944-3889      
Principal Investigator: Tamara Hannon         
United States, Louisiana
Pennington Biomedical Research Center Recruiting
Baton Rouge, Louisiana, United States, 70808-4124
Contact    225-763-2993      
Principal Investigator: Daniel Hsia         
United States, Missouri
Children's Mercy Hospital Recruiting
Kansas City, Missouri, United States, 64108
Contact    816-855-1769      
Principal Investigator: Mark A Clements         
United States, North Carolina
ECU Pediatric Specialty Care Recruiting
Greenville, North Carolina, United States, 27834
Contact    252-744-2161      
Principal Investigator: Jennifer Bell         
United States, Ohio
Cincinnati Childrens Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact    513-636-4744      
Principal Investigator: Amy Shah         
United States, Pennsylvania
Penn State Univ. Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033-0850
Contact    717-531-1022      
Principal Investigator: Ying Chang         
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact    215-426-7037      
Principal Investigator: Steven Willi         
Childrens Hospital of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact    412-692-6935      
Principal Investigator: Silva Arslanian         
United States, Washington
Seattle Children's Hospital Research Foundation Recruiting
Seattle, Washington, United States, 98105
Contact    206-987-1758      
Principal Investigator: Lina Merjaneh         
Multicare Health System Recruiting
Tacoma, Washington, United States, 98405
Contact    253-403-0776      
Principal Investigator: Gadi B. Kletter         
United States, West Virginia
CAMC Institute Recruiting
Charleston, West Virginia, United States, 25302
Contact    304-388-9679      
Principal Investigator: Sachin Bendre         
Brazil
Centro de Pesquisas em Diabetes Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90430-001
Contact    55 51 3268 4276      
Principal Investigator: Luis Henrique S Canani         
Instituto da Criança com Diabetes Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 91350-200
Contact    555133572698      
Principal Investigator: Balduino Tschiedel         
Instituto Estadual de Diabetes e Endocrinologia Recruiting
Rio de Janeiro, RJ, Brazil, 20211-340
Contact    552122256490      
Principal Investigator: Rodrigo de Oliveira Moreira         
Hospital PUC-CAMPINAS Recruiting
Campinas, Sao Paulo, Brazil, 13034-685
Contact    551933438526      
Principal Investigator: Mila Pontes Ramos Cunha         
Cpclin Centro de Pesquisas Clinicas Recruiting
São Paulo, SP, Brazil, 01228-200
Contact    55 11 2711 0251      
Principal Investigator: Denise R Franco         
Hospital da Clinicas da Faculdade de Medicina da USP Recruiting
São Paulo, SP, Brazil, 05403-000
Contact    551126617846      
Principal Investigator: Cintia Cercato         
Hospital das Clinicas da FMRP Recruiting
Ribeirao Preto, São Paulo, Brazil, 14048-900
Contact    551636022479      
Principal Investigator: Raphael Liberatore         
UNIFESP - Escola Paulista de Medicina Recruiting
São Paulo, Brazil, 04022-001
Contact    551155764982      
Principal Investigator: Sérgio Dib         
Canada, Alberta
Calgary Health Region Recruiting
Calgary, Alberta, Canada, T3B 6A8
Contact    4039557819      
Principal Investigator: Josephine Ho         
China, Guangdong
Peking University Shenzhen Hospital Not yet recruiting
Shenzhen, Guangdong, China, 518036
Contact    13600183666      
Principal Investigator: Fan Zhang         
China, Jiangsu
Children's hospital of Nanjing Not yet recruiting
Nanjing, Jiangsu, China, 210008
Contact    +86-18951769571      
Principal Investigator: Wei Gu         
Childrens Hospital of Suzhou Medical College Not yet recruiting
Suzhou, Jiangsu, China, 215003
Contact    86-18013573336      
Principal Investigator: Linqi CHEN         
Wuxi Children's Hospital Not yet recruiting
Wuxi, Jiangsu, China
Contact    86-13912389918      
Principal Investigator: Xu XU         
China, Jilin
No.2 Hospital Affiliated to Jilin University Not yet recruiting
Changchun City, Jilin, China, 130041
Contact    0431-88796974      
Principal Investigator: Han Qing Cai         
China
Peking Union Medical College Hospital Not yet recruiting
Beijing, China, 88798
Contact    010-69155088      
Principal Investigator: Yuxiu Li         
The Third Hospital of Nanchang Not yet recruiting
Nanchang, China, 330009
Contact    15970663750      
Principal Investigator: Tu Ping         
Children's hospital of Fudan University Not yet recruiting
Shanghai, China, 201102
Contact    86-13816881760      
Principal Investigator: Feihong LUO         
The Second Affiliated Hospital of Xian Jiaotong University Not yet recruiting
Xian City, China, 710004
Contact    2987679000      
Principal Investigator: Yanfeng Xiao         
France
Centre Hospitalier Universitaire de Bicetre Recruiting
Le Kremlin Bicetre, France, 94275
Contact    33145217835      
Principal Investigator: Christèle Kyheng         
Hopital Robert Debre Recruiting
Paris, France, 75019
Contact    33140034120      
Principal Investigator: Elise Bismuth-Reisman         
Germany
Praxis Dr. med. Landers Recruiting
Mayen, Rheinland-Pfalz, Germany, 56727
Contact    49265143160      
Principal Investigator: Bernhard Landers         
Schwerpunktpraxis Diabetes Recruiting
Saint Ingbert-Oberwürzbach, Saarland, Germany, 66386
Contact    496894998810      
Principal Investigator: Alexander Segner         
RED-Institut GmbH Recruiting
Oldenburg, Schleswig-Holstein, Germany, 23758
Contact    494361513130      
Principal Investigator: Thomas Schaum         
Hungary
Heim Pal Gyermekkorhaz Completed
Budapest, Hungary, 1089
India
Sir Ganga Ram Hospital Recruiting
New Delhi, Delhi, India, 110060
Contact    911142251547      
Principal Investigator: Archana Dayal Arya         
Dr. Jivraj Mehta Smarak Health Foundation Recruiting
Ahmedabad, Gujarat, India, 380007
Contact    917926639839      
Principal Investigator: Parag Shah         
Manipal Hospital Recruiting
Bangalore, Karmnataka, India, 560017
Contact    918025024631      
Principal Investigator: Shaila Bhattacharyya         
M S Ramaiah Medical College Hospital Recruiting
Bangalore, Karnataka, India, 560054
Contact    918022182982      
Principal Investigator: Chitra Selvan         
Deenanth Mangeshkar Hospital and Research Centre Recruiting
Pune, Maharashtra, India, 411004
Contact    912040151000      
Principal Investigator: Vaishali Deshmukh         
Post Graduate Institute of Medical Education & Research Recruiting
Chandigarh, Punjab, India, 160012
Contact    911722747944      
Principal Investigator: Anil Bhansali         
Banaras Hindu University - BHU Recruiting
Varanasi, Uttar Pradesh, India, 221005
Contact    915422309374      
Principal Investigator: Surya Kumar Singh         
Park Clinic Recruiting
Kolkata, West Bengal, India, 700017
Contact    919830021170      
Principal Investigator: Sudip Chatterjee         
Apollo Gleneagles Hospitals Recruiting
Kolkata, West Bengal, India, 700054
Contact    9836542460      
Principal Investigator: Subrata Dey         
Mexico
Health Pharma Professional Research, S.A. de C.V. Recruiting
Mexico City, Federal District, Mexico, 03810
Contact    525563814282      
Principal Investigator: Diego Gaytan Saracho         
Centro de Inv. Medica de Occidente, SC Recruiting
Zapopan, Jalisco, Mexico, 45116
Contact    523312044280      
Principal Investigator: Susana Emilia Pelayo         
Centro Medico San Francisco Recruiting
Monterrey, Nuevo Leon, Mexico, 64710
Contact    528117399494      
Principal Investigator: Hector Eloy Tamez         
Cli-nica Hospital Cemain Recruiting
Tampico, Tamaulipas, Mexico, 89249
Contact    528332412800      
Principal Investigator: Ricardo Salas         
Hospital Angeles Puebla Recruiting
Puebla, Mexico, 72190
Contact    522223038350      
Principal Investigator: Margarita Barrientos         
Arke Estudios Clinicos S.A. de C.V. Completed
Veracruz, Mexico, 91910
Puerto Rico
Centro de Diabetes y Endocrinologia Pediatrica de PR Recruiting
Bayamon, Puerto Rico, 00929
Contact    7876228451      
Principal Investigator: Carlos A. Leyva-Jordan         
Saudi Arabia
King Saud University Hospital Recruiting
Riyadh, Saudi Arabia, 11472
Contact    9660114690746      
Principal Investigator: Reem Abdullah H.Al Khalifa         
King Salman bin Abdulaziz Hospital - Diabetic Center Recruiting
Riyadh, Saudi Arabia, 12769
Contact    +966502130691      
Principal Investigator: Najim Abdulwahid         
Turkey
Ankara University Medicine Hospital Recruiting
Ankara, Mamak, Turkey, 06100
Contact    +90 506 240 01 03      
Principal Investigator: Zehra Aycan         
Sami Ulus Education & Research Hospital Recruiting
Ankara, Turkey, 06080
Contact    90 506 240 01 03      
Principal Investigator: Semra Cetinkaya         
Duzce University Medical Faculty Recruiting
Duzce, Turkey, 81620
Contact    90 380 542 14 44      
Principal Investigator: Ilknur Arslanoglu         
Ondokuz Mayis University Medical Faculty Completed
Samsun, Turkey, 55139
United Kingdom
Alder Hey Children's Hospital Recruiting
Liverpool, Lancashire, United Kingdom, L14 5AB
Contact    441512284811      
Principal Investigator: Princy Paul         
St James's University Hospital Recruiting
Leeds, West Yorkshire, United Kingdom, LS9 7TF
Contact    441132064996      
Principal Investigator: James Yong         
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: 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) Eli Lilly and Company

Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02963766     History of Changes
Other Study ID Numbers: 14171
H9X-MC-GBGC ( Other Identifier: Eli Lilly and Company )
2016-000361-22 ( EudraCT Number )
First Posted: November 15, 2016    Key Record Dates
Last Update Posted: October 18, 2019
Last Verified: October 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

Keywords provided by Eli Lilly and Company:
Pediatrics
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Dulaglutide
Immunoglobulin Fc Fragments
Hypoglycemic Agents
Physiological Effects of Drugs
Immunologic Factors