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 | 
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.
			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
	
									3020 Childrens way
San Diego, California 92123
	
			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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									1720 2nd Ave S
Birmingham, Alabama 35233
	
			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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									3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
	
			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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									550 University Boulevard
Indianapolis, Indiana 46202
	
			
					Indianapolis, Indiana 46202
Principal Investigator: Tamara Hannon
			
						
										Phone: 317-944-3889
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									2401 Gillham Rd
Kansas City, Missouri 64108
	
			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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									1201 W La Veta Ave
Orange, California 92868
	
			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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									South 34th Street
Philadelphia, Pennsylvania 19104
	
			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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								Anaheim, California 92805			
	
			
					Principal Investigator: Patrick Walsh
			
						
										Phone: 714-999-6688
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									6400 Perkins Rd
Baton Rouge, Louisiana 70808
	
			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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								Charleston, West Virginia 25304			
	
			
					Principal Investigator: Sachin Bendre
			
						
										Phone: 304-388-9679
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									 2035 W Taylor St
Chicago, Illinois
	
			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
	
			
					Gainesville, Florida 32608
Principal Investigator: Janet Silverstein
			
						
										Phone: 352-265-7337
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									2150 Herbert Court
Greenville, North Carolina 27834
	
			
					Greenville, North Carolina 27834
Principal Investigator: Jennifer Bell
			
						
										Phone: 252-744-2516
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									92 2nd St
Hackensack, New Jersey 07601
	
			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
	
			
					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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								Seattle, Washington 98105			
	
			
					Principal Investigator: Lina Merjaneh
			
						
										Phone: 206-987-1758
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									314 Martin Luther King Junior Way
Tacoma, Washington 98405
	
			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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									111 Michigan Ave NW
Washington, District of Columbia
	
			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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