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A Study of Dulaglutide (LY2189265) in Children and Adolescents With Type 2 Diabetes | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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)

NCT02963766•Eli Lilly and Company

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

10 - 17 years

Sex

ALL

Healthy Volunteers

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 or hyperglycemic hyperosmolar syndrome.
•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 ≥100 mmHg.
•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 (6 weeks for bolus or mealtime insulin).
•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.
+2 more criteria

Locations (61)

University of Alabama Birmingham

Birmingham, Alabama, United States

University of Arizona

Tucson, Arizona, United States

Advanced Research Center

Anaheim, California, United States

Division of Endocrinology, Diabetes, and Metabolism

Los Angeles, California, United States

Childrens Hospital of Orange County

Orange, California, United States

Center of Excellence in Diabetes & Endocrinology

Sacramento, California, United States

Rady Childrens Hospital - San Diego

San Diego, California, United States

JC Cabaccan

San Jose, California, United States

Touro University

Vallejo, California, United States

Children's National Medical Center

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

Key Dates

Start Date

December 29, 2016

Primary Completion Date

June 12, 2021

Completion Date

January 12, 2022

Last Updated

July 1, 2022

Enrollment

154

ACTUAL participants

Conditions

Type 2 Diabetes

Interventions

Dulaglutide

DRUG

Placebo

DRUG

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

View study

RECRUITINGPHASE2

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

NCT07296484

Type 2 DiabetesCortisol Excess

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 1, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

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