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



Status:Recruiting
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:10 - 17
Updated:4/5/2019
Start Date:December 29, 2016
End Date:January 27, 2022
Contact:There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Phone:1-317-615-4559

Use our guide to learn which trials are right for you!

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)

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.


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.
We found this trial at
29
sites
South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Principal Investigator: Steven Willi
Phone: 215-426-7037
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Mary Lauren Scott
Phone: 2059969569
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Principal Investigator: Amy Shah
Phone: 513-636-4744
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
550 University Boulevard
Indianapolis, Indiana 46202
Principal Investigator: Tamara Hannon
Phone: 317-944-3889
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
2401 Gillham Rd
Kansas City, Missouri 64108
(816) 234-3000
Principal Investigator: Mark A Clements
Phone: 816-855-1769
Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
1201 W La Veta Ave
Orange, California 92868
(714) 997-3000
Principal Investigator: Nikta Forghani
Phone: 714-509-8634
Children's Hospital of Orange County For more than 45 years, CHOC Children’s has been steadfastly...
?
mi
from
Orange, CA
Click here to add this to my saved trials
3020 Childrens way
San Diego, California 92123
(858) 576-1700
Principal Investigator: Michael E Gottschalk
Phone: 858-966-8400
Rady Children's Hospital - San Diego Rady Children's Hospital-San Diego is the region’s pediatric medical...
?
mi
from
San Diego, CA
Click here to add this to my saved trials
Anaheim, California 92805
Principal Investigator: Patrick Walsh
Phone: 714-999-6688
?
mi
from
Anaheim, CA
Click here to add this to my saved trials
6400 Perkins Rd
Baton Rouge, Louisiana 70808
(225) 763-2500
Principal Investigator: Daniel Hsia
Phone: 225-763-2993
Pennington Biomedical Research Center Unlike other medical research facilities where science occurs in separate labs...
?
mi
from
Baton Rouge, LA
Click here to add this to my saved trials
Boise, Idaho 83712
Principal Investigator: Daniel Flynn
Phone: 208-381-8923
?
mi
from
Boise, ID
Click here to add this to my saved trials
Charleston, West Virginia 25304
Principal Investigator: Sachin Bendre
Phone: 304-388-9679
?
mi
from
Charleston, WV
Click here to add this to my saved trials
2035 W Taylor St
Chicago, Illinois
(312) 996-4350
Principal Investigator: Claudia Boucher-Berry
Phone: 312-996-1795
University of Illinois at Chicago A major research university in the heart of one of...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
DeLand, Florida 32724
Principal Investigator: Lee Metchick
Phone: 386-785-2408
?
mi
from
DeLand, FL
Click here to add this to my saved trials
3450 Hull Road
Gainesville, Florida 32608
Principal Investigator: Janet Silverstein
Phone: 352-265-7337
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
2150 Herbert Court
Greenville, North Carolina 27834
Principal Investigator: Jennifer Bell
Phone: 252-744-2516
?
mi
from
Greenville, NC
Click here to add this to my saved trials
92 2nd St
Hackensack, New Jersey 07601
(201) 996-5900
Principal Investigator: Steven Ghanny
Phone: 201-996-5673
John Theurer Cancer Center at the Hackensack University Medical Center The mission of the John...
?
mi
from
Hackensack, NJ
Click here to add this to my saved trials
Hershey, Pennsylvania 17033
Principal Investigator: Ying Chang
Phone: 717-531-1022
?
mi
from
Hershey, PA
Click here to add this to my saved trials
Los Angeles, California 90027
Principal Investigator: Lily Chao
Phone: 323-361-7116
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Miami, Florida 33155
Principal Investigator: Luis E. Gonzalez-Mendoza
Phone: 786-624-2854
?
mi
from
Miami, FL
Click here to add this to my saved trials
Orlando, Florida 32803
Principal Investigator: Konda Reddy
Phone: 407-896-2901
?
mi
from
Orlando, FL
Click here to add this to my saved trials
3414 Fifth Avenue
Pittsburgh, Pennsylvania 15213
Principal Investigator: Silva Arslanian
Phone: 412-692-6935
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Porto Alegre, Rio Grande Do Sul 90430
Principal Investigator: Luis Henrique S Canani
Phone: 55 51 3268 4276
?
mi
from
Porto Alegre,
Click here to add this to my saved trials
Sacramento, California 98521
Principal Investigator: Gnanagurudasan Prakasam
Phone: 916-426-1902
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
San Jose, California 95148
Principal Investigator: Josel Cabaccan
Phone: 408-223-7000
?
mi
from
San Jose, CA
Click here to add this to my saved trials
Seattle, Washington 98105
Principal Investigator: Lina Merjaneh
Phone: 206-987-1758
?
mi
from
Seattle, WA
Click here to add this to my saved trials
314 Martin Luther King Junior Way
Tacoma, Washington 98405
(253) 403-5200
Principal Investigator: Gadi B. Kletter
Phone: 253-403-0776
Multicare Health System MultiCare is a not-for-profit health care organization with more than 10,000 employees...
?
mi
from
Tacoma, WA
Click here to add this to my saved trials
Tucson, Arizona 85721
(520) 621-2211
Principal Investigator: Mark Wheeler
Phone: 520-626-6077
University of Arizona The University of Arizona is a premier, public research university. Established in...
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
Vallejo, California 94592
Principal Investigator: Jay Shubrook
Phone: 707-638-6969
?
mi
from
Vallejo, CA
Click here to add this to my saved trials
111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
Principal Investigator: Andrew Dauber
Phone: 202-476-1403
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
?
mi
from
Washington,
Click here to add this to my saved trials