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

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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
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...
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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...
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Birmingham, AL
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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...
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Cincinnati, OH
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550 University Boulevard
Indianapolis, Indiana 46202
Principal Investigator: Tamara Hannon
Phone: 317-944-3889
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Indianapolis, IN
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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...
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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...
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Philadelphia, PA
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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...
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Anaheim, California 92805
Principal Investigator: Patrick Walsh
Phone: 714-999-6688
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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...
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Boise, Idaho 83712
Principal Investigator: Daniel Flynn
Phone: 208-381-8923
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Boise, ID
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Charleston, West Virginia 25304
Principal Investigator: Sachin Bendre
Phone: 304-388-9679
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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...
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DeLand, Florida 32724
Principal Investigator: Lee Metchick
Phone: 386-785-2408
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3450 Hull Road
Gainesville, Florida 32608
Principal Investigator: Janet Silverstein
Phone: 352-265-7337
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2150 Herbert Court
Greenville, North Carolina 27834
Principal Investigator: Jennifer Bell
Phone: 252-744-2516
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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...
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Hershey, Pennsylvania 17033
Principal Investigator: Ying Chang
Phone: 717-531-1022
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Los Angeles, California 90027
Principal Investigator: Lily Chao
Phone: 323-361-7116
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Miami, Florida 33155
Principal Investigator: Luis E. Gonzalez-Mendoza
Phone: 786-624-2854
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Orlando, Florida 32803
Principal Investigator: Konda Reddy
Phone: 407-896-2901
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3414 Fifth Avenue
Pittsburgh, Pennsylvania 15213
Principal Investigator: Silva Arslanian
Phone: 412-692-6935
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Porto Alegre, Rio Grande Do Sul 90430
Principal Investigator: Luis Henrique S Canani
Phone: 55 51 3268 4276
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Sacramento, California 98521
Principal Investigator: Gnanagurudasan Prakasam
Phone: 916-426-1902
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San Jose, California 95148
Principal Investigator: Josel Cabaccan
Phone: 408-223-7000
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Seattle, Washington 98105
Principal Investigator: Lina Merjaneh
Phone: 206-987-1758
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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...
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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...
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Vallejo, California 94592
Principal Investigator: Jay Shubrook
Phone: 707-638-6969
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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...
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