Actively Recruiting

Phase 3
Age: 10Years - 17Years
All Genders
NCT06739122

A Study of Dulaglutide (LY2189265) 3.0 mg and 4.5 mg in Pediatric Participants With Type 2 Diabetes Mellitus (AWARD-PEDS PLUS)

Led by Eli Lilly and Company · Updated on 2026-05-12

55

Participants Needed

51

Research Sites

150 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The main purpose of this study is to evaluate additional dosing options for dulaglutide in pediatric participants with Type 2 Diabetes. Participation in this study will last about 8 months.

CONDITIONS

Official Title

A Study of Dulaglutide (LY2189265) 3.0 mg and 4.5 mg in Pediatric Participants With Type 2 Diabetes Mellitus (AWARD-PEDS PLUS)

Who Can Participate

Age: 10Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Have Type 2 diabetes treated with diet, exercise, metformin, and/or basal insulin with stable doses for at least 8 weeks prior to screening
  • Have a body weight of 50 kilograms or more
  • Have a Body Mass Index (BMI) above the 85th percentile
Not Eligible

You will not qualify if you...

  • Have Type 1 diabetes
  • Have used glucose-lowering agents other than metformin, basal insulin, or dulaglutide within 8 weeks prior to screening
  • Have a history of diabetic ketoacidosis or hyperosmolar syndrome after Type 2 diabetes diagnosis
  • Have had one or more episodes of severe hypoglycemia or hypoglycemic unawareness within the last 6 months
  • Have family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
  • Have prior chronic, recurrent, or idiopathic pancreatitis or known gallbladder disease
  • Have used prescription or over-the-counter weight loss medications within 8 weeks prior to screening

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 51 locations

1

University of Arizona

Tucson, Arizona, United States, 85724

Actively Recruiting

2

Arkansas Childrens Hospital

Little Rock, Arkansas, United States, 72202-3500

Actively Recruiting

3

Division of Endocrinology, Diabetes, and Metabolism

Los Angeles, California, United States, 90027

Actively Recruiting

4

UCLA Mattel Children's Hospital

Los Angeles, California, United States, 90095

Actively Recruiting

5

University of California, San Francisco

San Francisco, California, United States, 94158

Actively Recruiting

6

Children's Hospital of Colorado

Denver, Colorado, United States, 80045

Not Yet Recruiting

7

Yale Diabetes Research

New Haven, Connecticut, United States, 06511

Actively Recruiting

8

Emerson Clinical Research Institute

Washington D.C., District of Columbia, United States, 20009

Actively Recruiting

9

Children's National Medical Center

Washington D.C., District of Columbia, United States, 20010

Not Yet Recruiting

10

Nemours Children's Health

Jacksonville, Florida, United States, 32207

Actively Recruiting

11

D&H National Research Centers, Inc

Miami, Florida, United States, 33155

Actively Recruiting

12

AdventHealth Orlando

Orlando, Florida, United States, 32803

Actively Recruiting

13

D&H Tamarac Research Center, LLC

Tamarac, Florida, United States, 33321

Actively Recruiting

14

University of South Florida

Tampa, Florida, United States, 33612

Actively Recruiting

15

Children's Healthcare of Atlanta - Center for Advanced Pediatrics

Atlanta, Georgia, United States, 30329

Actively Recruiting

16

Centricity Research Columbus Endocrinology

Columbus, Georgia, United States, 31904

Actively Recruiting

17

St. Luke's Children's Endocrinology and Diabetes

Boise, Idaho, United States, 83712

Actively Recruiting

18

University of Illinois at Chicago

Chicago, Illinois, United States, 60612

Actively Recruiting

19

Center for Diabetes and Metabolic Diseases Indiana University

Indianapolis, Indiana, United States, 46202

Not Yet Recruiting

20

University of Iowa Stead Family Children's Hospitals

Iowa City, Iowa, United States, 52242

Actively Recruiting

21

Norton Children's Endocrinology

Louisville, Kentucky, United States, 40202

Actively Recruiting

22

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States, 21287

Actively Recruiting

23

University of Mississippi Medical Center

Jackson, Mississippi, United States, 39216

Actively Recruiting

24

University of New Mexico Hospital

Albuquerque, New Mexico, United States, 87106

Actively Recruiting

25

WBMD Pediatrics

Buffalo, New York, United States, 14203

Actively Recruiting

26

Cohen Children's Medical Center Division of Pediatric Endocrinology

Hyde Park, New York, United States, 11042

Actively Recruiting

27

SUNY Upstate Medical University

Syracuse, New York, United States, 13210

Actively Recruiting

28

UNC Children's Hospital

Chapel Hill, North Carolina, United States, 27514

Actively Recruiting

29

Childrens Hospital Medical Center

Cincinnati, Ohio, United States, 45229

Actively Recruiting

30

Cleveland Clinic Childrens Outpatient Center

Cleveland, Ohio, United States, 44106

Actively Recruiting

31

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States, 73104

Actively Recruiting

32

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

33

St Christophers Hospital For Children

Philadelphia, Pennsylvania, United States, 19134

Not Yet Recruiting

34

Prisma Health Pediatric Endocrinology

Columbia, South Carolina, United States, 29203

Actively Recruiting

35

Prisma Health Midlands

Greenville, South Carolina, United States, 29615

Actively Recruiting

36

Research Institute of Dallas

Dallas, Texas, United States, 75231

Actively Recruiting

37

Texas Childrens Hospital

Houston, Texas, United States, 77030

Actively Recruiting

38

UT Health Houston

Houston, Texas, United States, 77030

Actively Recruiting

39

University of Utah

Salt Lake City, Utah, United States, 84112

Actively Recruiting

40

Seattle Children's Hospital

Seattle, Washington, United States, 98105

Actively Recruiting

41

Children's Wisconsin - Milwaukee Campus

Milwaukee, Wisconsin, United States, 53226

Not Yet Recruiting

42

Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

Buenos Aires, Argentina, C1425

Not Yet Recruiting

43

Centro de Investigaciones Médicas Mar del Plata

Mar del Plata, Argentina, B7600FYK

Not Yet Recruiting

44

INECO Neurociencias Oroño

Rosario, Argentina, 2000

Not Yet Recruiting

45

Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L

San Miguel de Tucumán, Argentina, T4000IHE

Not Yet Recruiting

46

Go Centro Medico San Nicolás

San Nicolás, Argentina, 2900

Not Yet Recruiting

47

Centro de Estudios de Investigacion Metabolicos y Cardiovasculares

Ciudad Madero, Mexico, 89440

Not Yet Recruiting

48

Hospital Angeles (HA) - Puebla

Puebla City, Mexico, 72190

Not Yet Recruiting

49

Clínica Cemain

Tampico, Mexico, 89210

Not Yet Recruiting

50

Innovacion y Desarrollo de Estrategias en Salud SA de CV

Tlalpan, Mexico, 14090

Not Yet Recruiting

51

Arké SMO S.A de C.V

Veracruz, Mexico, 91910

Not Yet Recruiting

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Research Team

T

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

P

Physicians interested in becoming principal investigators please contact

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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