Clinical Trial Details

NCT ID: NCT02963766
Date Last Changed: October 2, 2017

Overview

Research Study Summary

A clinical research study of Dulaglutide and Placebo for the treatment of Type 2 Diabetes

Research Study 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)

Purpose

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.

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Recruitment Details

Phase
3
Gender
All
Age
10 to 17 Years
Overall Status
Recruiting
Lead Sponsor
Eli Lilly and Company
Duration
60 Months
Facility Type
N/A
Compensation

Eligibility

All ages 10 Years to 17 Years

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.

Site Locations (55)

Country State City Zip Facility and Contact
United States Alabama Birmingham 35233 University of Alabama Birmingham
205-939-9107

GAIL MICK
Principal Investigator
United States California Orange 92868 Childrens Hospital of Orange County
714-532-8613

Nikta Forghani
Principal Investigator
United States California Palmdale 93550 San Fernando Valley Research Associates
661-538-9922

Sherif Khamis
Principal Investigator
United States California Sacramento 95821 Center of Excellence in Diabetes & Endocrinology
916-228-4288

Gnanagurudasan Prakasam
Principal Investigator
United States California San Diego 92123 Rady Childrens Hospital - San Diego
858-966-4032

Michael Gottschalk
Principal Investigator
United States California Vallejo 94592 Touro University
707-638-6969

Jay Shubrook
Principal Investigator
United States Florida Gainesville 32608 Univ of Florida School of Medicine
352-265-7337

Janet Silverstein
Principal Investigator
United States Florida Miami 33155 Nickalus Children's Hospital Research Institute
786-624-2854

Luis Gonzalez-Mendoza
Principal Investigator
United States Florida Orlando 32803 Florida Center for Endocrinology & Metabolism
407-896-2901

Konda Reddy
Principal Investigator
United States Idaho Boise 83712 St Lukes Regional Medical Center
208-381-8937

Daniel Flynn
Principal Investigator
United States Illinois Chicago 60612 University of Illinois at Chicago
312-996-1795

Claudia Boucher-Berry
Principal Investigator
United States Indiana Indianapolis 46202 Indiana University Hospital
317-944-3889

Tamara Hannon
Principal Investigator
United States Louisiana Baton Rouge 70808-4124 Pennington Biomedical Research Center
225-763-2831

Daniel Hsia
Principal Investigator
United States New Jersey Hackensack 07601 Hackensack University Medical Center
201-996-5673

Steven Ghanny
Principal Investigator
United States Oregon Portland 97227 Emanuel Hospital and Health Center
503-413-1600

Maya Hunter
Principal Investigator
United States Pennsylvania Pittsburgh 15224 Childrens Hospital of Pittsburgh
412-692-5055

Silva Arslanian
Principal Investigator
United States Tennessee Memphis 38103 University of Tennessee
901-448-5240

Helmut Steinberg
Principal Investigator
United States Washington Bellevue 98007-4209 Northwest Clinical Research Center
208-381-8937

Gaylon Kipp
Principal Investigator
United States Washington Seattle 98105 Seattle Children's Hospital Research Foundation
206-987-5271

Lina Merjaneh
Principal Investigator
United States Washington Tacoma 98405 Multicare Health System
253-403-1000

Gadi Kletter
Principal Investigator
United States West Virginia Charleston 25302 CAMC Institute
832-567-0449

Sachin Bendre
Principal Investigator
Brazil Porto Alegre 90035-170 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Eli Lilly and Company
Brazil Porto Alegre 91350-250 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Eli Lilly and Company
Brazil Ribeirao Preto 14048-900 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Eli Lilly and Company
Brazil Sao Paulo 01244-030 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Eli Lilly and Company
Brazil Sao Paulo 04022-001 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Eli Lilly and Company
Brazil Sao Paulo 05403-010 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Eli Lilly and Company
Canada Calgary T3B 6A8 For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
Eli Lilly and Company
Canada Saskatoon S7N 0W8 For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
Eli Lilly and Company
France Le Kremlin Bicetre Cedex 94275 For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
Eli Lilly and Company
France Paris 75019 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Eli Lilly and Company
Germany Bad Mergentheim 97980 Diabetespraxis Mergentheim
497931594131

Simone Hofmann
Principal Investigator
Germany Mayen 56727 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Eli Lilly and Company
Germany Oldenburg 23758 For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
Eli Lilly and Company
Hungary Budapest 1083 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Eli Lilly and Company
Hungary Budapest 1089 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Eli Lilly and Company
India Ahmedabad 380007 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Eli Lilly and Company
India Bangalore 560017 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Eli Lilly and Company
India Bangalore 560054 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Eli Lilly and Company
India Hyderabad 500012 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Eli Lilly and Company
India Kolkata 700054 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Eli Lilly and Company
India Varanasi 221005 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Eli Lilly and Company
Mexico Mexico 03810 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Eli Lilly and Company
Mexico Mexico 91910 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Eli Lilly and Company
Mexico Monterrey 64710 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Eli Lilly and Company
Mexico Puebla 72190 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Eli Lilly and Company
Mexico Tampico 89249 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Eli Lilly and Company
Mexico Zapopan 45116 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Eli Lilly and Company
Puerto Rico Rio Piedras 00923 Centro de Diabetes y Endocrinologia Pediatrica de PR
7877672929

Carlos Leyva-Jordan
Principal Investigator
Saudi Arabia Riyadh 11472 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Eli Lilly and Company
Turkey Ankara 06080 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Eli Lilly and Company
Turkey Duzce 81620 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Eli Lilly and Company
Turkey Samsun 55139 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Eli Lilly and Company
United Kingdom Leeds LS9 7TF For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Eli Lilly and Company
United Kingdom Liverpool L14 5AB For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Eli Lilly and Company

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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