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

NCT02963766 | Completed Phase 3 Results DMC

• 3 other identifiers: 14171H9X-MC-GBGC2016-000361-22
• Study Type: interventional
• Target: 154
• Locations: 11 countries
• Sites: 61

Brief 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.

Conditions

Type 2 Diabetes

Keywords

Pediatrics

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses) at Week 26

  HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least square (LS) mean in HbA1c was calculated using a restricted maximum likelihood (REML) based mixed-effects model for repeated measures (MMRM) and adjusted by, baseline + insulin Use + metformin Use + treatment + time + treatment\*time (Type III sum of squares). Variance-covariance structure = unstructured (for actual value) / unstructured (for change from baseline).

  Baseline, Week 26

Secondary Outcomes (15)

• Change From Baseline in HbA1c (Individual Doses) at Week 26

  Baseline, Week 26

• Change From Baseline in Fasting Blood Glucose (FBG) at Week 26

  Baseline, Week 26

• Percentage of Participants With HbA1c ≤7.0%

  Week 26

• Change From Baseline in Body Mass Index (BMI) at Week 26

  Baseline, Week 26

• Percentage of Participants With Self-Reported Events of Hypoglycemia

  Week 26

Study Arms (3)

Placebo/0.75 milligram (mg) Dulaglutide

EXPERIMENTAL

Participants received placebo administered subcutaneously (SC) for 26 weeks during the double-blind period and open-label 0.75 mg/week dulaglutide for 26 weeks during the Open Label Extension (OLE).

Drug: Dulaglutide; Drug: Placebo

0.75 mg Dulaglutide

EXPERIMENTAL

Participants received 0.75 mg/week dulaglutide administered SC for 26 weeks during the double-blind period and open-label 0.75 mg/week for 26 weeks during the OLE.

Drug: Dulaglutide

1.5 mg Dulaglutide

EXPERIMENTAL

Participants received 1.5 mg/week dulaglutide administered SC for 26 weeks during the double-blind period and open-label 1.5 mg/week for 26 weeks during the OLE.

Drug: Dulaglutide

Interventions

Dulaglutide DRUG

Administered SC

Also known as: LY2189265

0.75 mg Dulaglutide; 1.5 mg Dulaglutide; Placebo/0.75 milligram (mg) Dulaglutide

Placebo DRUG

Administered SC

Placebo/0.75 milligram (mg) Dulaglutide

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (61)

University of Alabama Birmingham

Birmingham, Alabama, 35233, United States

Location

University of Arizona

Tucson, Arizona, 85724, United States

Location

Advanced Research Center

Anaheim, California, 92805, United States

Location

Division of Endocrinology, Diabetes, and Metabolism

Los Angeles, California, 90027, United States

Location

Childrens Hospital of Orange County

Orange, California, 92868, United States

Location

Center of Excellence in Diabetes & Endocrinology

Sacramento, California, 95821, United States

Location

Rady Childrens Hospital - San Diego

San Diego, California, 92123, United States

Location

JC Cabaccan

San Jose, California, 95148, United States

Location

Touro University

Vallejo, California, 94592, United States

Location

Children's National Medical Center

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

Location

Florida Center for Endocrinology & Metabolism

Orlando, Florida, 32803, United States

Location

St. Luke's Regional Medical Center

Boise, Idaho, 83712, United States

Location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Indiana University Health Hospital

Indianapolis, Indiana, 46202, United States

Location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808-4124, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

ECU Pediatric Specialty Care

Greenville, North Carolina, 27834, United States

Location

Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Childrens Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

Seattle Children's Hospital Research Foundation

Seattle, Washington, 98105, United States

Location

Multicare Health System

Tacoma, Washington, 98405, United States

Location

CAMC Institute

Charleston, West Virginia, 25302, United States

Location

Instituto Estadual de Diabetes e Endocrinologia

Rio de Janeiro, Rio de Janeiro, 20211-340, Brazil

Location

Centro de Pesquisas em Diabetes

Porto Alegre, Rio Grande do Sul, 90430-001, Brazil

Location

Instituto da Criança com Diabetes

Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

Location

Hospital PUC-CAMPINAS

Campinas, São Paulo, 13034-685, Brazil

Location

Hospital das Clinicas da FMRP

Ribeirão Preto, São Paulo, 14051-140, Brazil

Location

CPCLIN

São Paulo, São Paulo, 01228-200, Brazil

Location

Hospital da Clinicas da Faculdade de Medicina da USP

São Paulo, São Paulo, 05403-000, Brazil

Location

UNIFESP - Escola Paulista de Medicina

São Paulo, 04022-001, Brazil

Location

Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre

Le Kremlin-Bicêtre, 94275, France

Location

Hopital Robert Debre

Paris, 75019, France

Location

Praxis Dr. med. Landers

Mayen, Rhineland-Palatinate, 56727, Germany

Location

Zentrum für klinische Studien

Sankt Ingbert, Saarland, 66386, Germany

Location

RED-Institut GmbH

Oldenburg in Holstein, Schleswig-Holstein, 23758, Germany

Location

Heim Pal Gyermekkorhaz

Budapest, 1089, Hungary

Location

Dr Jivraj Mehta Smarak Health Foundation Bakeri Medical Research Centre

Ahmedabad, Gujarat, 380007, India

Location

Manipal Hospital

Bangalore, Karmnataka, 560017, India

Location

M S Ramaiah Medical College Hospital

Bangalore, Karnataka, 560054, India

Location

Deenanath Mangeshkar Hospital & Research Centre

Pune, Maharashtra, 411004, India

Location

Sir Ganga Ram Hospital

New Delhi, National Capital Territory of Delhi, 110060, India

Location

Post Graduate Institute of Medical Education & Research

Chandigarh, Punjab, 160012, India

Location

Banaras Hindu University - BHU

Varanasi, Uttar Pradesh, 221005, India

Location

Park Clinic

Kolkata, West Bengal, 700017, India

Location

Apollo Gleneagles Hospitals Kolkata

Kolkata, West Bengal, 700054, India

Location

Health Pharma Professional Research, S.A. de C.V.

Mexico City, Federal District, 03810, Mexico

Location

Centro de Inv. Medica de Occidente, SC

Zapopan, Jalisco, 45116, Mexico

Location

Centro Medico San Francisco

Monterrey, Nuevo León, 64710, Mexico

Location

Cli-nica Hospital Cemain

Tampico, Tamaulipas, 89249, Mexico

Location

Hospital Angeles Puebla

Puebla City, 72190, Mexico

Location

Arke Estudios Clinicos S.A. de C.V.

Veracruz, 91910, Mexico

Location

Centro de Diabetes y Endocrinologia Pediatrica de PR

Bayamón, PR, 00959, Puerto Rico

Location

King Saud University Hospital

Riyadh, 11472, Saudi Arabia

Location

King Salman bin Abdulaziz Hospital - Diabetic Center

Riyadh, 12769, Saudi Arabia

Location

Ankara University Medicine Hospital

Ankara, Mamak, 06100, Turkey (Türkiye)

Location

Sami Ulus Education & Research Hospital

Ankara, 06080, Turkey (Türkiye)

Location

Duzce University Medical Faculty

Düzce, 81620, Turkey (Türkiye)

Location

Ondokuz Mayis University Medical Faculty

Samsun, 55139, Turkey (Türkiye)

Location

Alder Hey Children's Hospital

Liverpool, Lancashire, L14 5AB, United Kingdom

Location

St James's University Hospital

Leeds, West Yorkshire, LS9 7TF, United Kingdom

Location

Related Publications (2)

• Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2.

  PMID: 39963952 DERIVED

• Arslanian SA, Hannon T, Zeitler P, Chao LC, Boucher-Berry C, Barrientos-Perez M, Bismuth E, Dib S, Cho JI, Cox D; AWARD-PEDS Investigators. Once-Weekly Dulaglutide for the Treatment of Youths with Type 2 Diabetes. N Engl J Med. 2022 Aug 4;387(5):433-443. doi: 10.1056/NEJMoa2204601. Epub 2022 Jun 4.

  PMID: 35658022 DERIVED

Related Links

• A Study of Dulaglutide (LY2189265) in Children and Adolescents With Type 2 Diabetes (AWARD-PEDS)

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dulaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2016
• First Posted: November 15, 2016
• Study Start: December 29, 2016
• Primary Completion: June 12, 2021
• Study Completion: January 12, 2022
• Last Updated: July 1, 2022
• Results First Posted: July 1, 2022

Record last verified: 2022-06-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

GB (2); US (23); ME (6); FR (2); DE (3); PR (1); TU (4); HU (1); BR (8); IN (9); SA (2)