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Type 2 DiabetesPhase 3AWARD-PEDSNCT02963766

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

A Phase 3 study testing Dulaglutide in people with Type 2 Diabetes, run by Eli Lilly and Company at 61 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 10 to 17 years
Conditions the study is for
Type 2 Diabetes
What is being tested?
Dulaglutide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
154 participants
Where
61 sitesin 11 countries
Study dates
29 Dec 2016to 12 Jan 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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).

Who cannot join

  • 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.
Show all 12Show fewer
  • 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.

Trial locations and contacts

61 sites in 11 countries.

61 sites in 11 countries

United States23 sites

  • Advanced Research Center

    Anaheim, California, 92805

  • Pennington Biomedical Research Center

    Baton Rouge, Louisiana, 70808-4124

  • University of Alabama Birmingham

    Birmingham, Alabama, 35233

  • St. Luke's Regional Medical Center

    Boise, Idaho, 83712

  • CAMC Institute

    Charleston, West Virginia, 25302

  • University of Illinois at Chicago

    Chicago, Illinois, 60612

  • Cincinnati Childrens Hospital Medical Center

    Cincinnati, Ohio, 45229

  • ECU Pediatric Specialty Care

    Greenville, North Carolina, 27834

  • Indiana University Health Hospital

    Indianapolis, Indiana, 46202

  • Children's Mercy Hospital

    Kansas City, Missouri, 64108

  • Division of Endocrinology, Diabetes, and Metabolism

    Los Angeles, California, 90027

  • Childrens Hospital of Orange County

    Orange, California, 92868

  • Florida Center for Endocrinology & Metabolism

    Orlando, Florida, 32803

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • Childrens Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15224

  • Center of Excellence in Diabetes & Endocrinology

    Sacramento, California, 95821

  • Rady Childrens Hospital - San Diego

    San Diego, California, 92123

  • JC Cabaccan

    San Jose, California, 95148

  • Seattle Children's Hospital Research Foundation

    Seattle, Washington, 98105

  • Multicare Health System

    Tacoma, Washington, 98405

  • University of Arizona

    Tucson, Arizona, 85724

  • Touro University

    Vallejo, California, 94592

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010

Other trials in United States

India9 sites

  • Dr Jivraj Mehta Smarak Health Foundation Bakeri Medical Research Centre

    Ahmedabad, Gujarat, 380007

  • Manipal Hospital

    Bangalore, Karmnataka, 560017

  • M S Ramaiah Medical College Hospital

    Bangalore, Karnataka, 560054

  • Post Graduate Institute of Medical Education & Research

    Chandigarh, Punjab, 160012

  • Park Clinic

    Kolkata, West Bengal, 700017

  • Apollo Gleneagles Hospitals Kolkata

    Kolkata, West Bengal, 700054

  • Sir Ganga Ram Hospital

    New Delhi, National Capital Territory of Delhi, 110060

  • Deenanath Mangeshkar Hospital & Research Centre

    Pune, Maharashtra, 411004

  • Banaras Hindu University - BHU

    Varanasi, Uttar Pradesh, 221005

Other trials in India

Brazil8 sites

  • Hospital PUC-CAMPINAS

    Campinas, São Paulo, 13034-685

  • Centro de Pesquisas em Diabetes

    Porto Alegre, Rio Grande do Sul, 90430-001

  • Instituto da Criança com Diabetes

    Porto Alegre, Rio Grande do Sul, 91350-200

  • Hospital das Clinicas da FMRP

    Ribeirão Preto, São Paulo, 14051-140

  • Instituto Estadual de Diabetes e Endocrinologia

    Rio de Janeiro, Rio de Janeiro, 20211-340

  • CPCLIN

    São Paulo, São Paulo, 01228-200

  • Hospital da Clinicas da Faculdade de Medicina da USP

    São Paulo, São Paulo, 05403-000

  • UNIFESP - Escola Paulista de Medicina

    São Paulo, 04022-001

Other trials in Brazil

Mexico6 sites

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

    Mexico City, Federal District, 03810

  • Centro Medico San Francisco

    Monterrey, Nuevo León, 64710

  • Hospital Angeles Puebla

    Puebla City, 72190

  • Cli-nica Hospital Cemain

    Tampico, Tamaulipas, 89249

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

    Veracruz, 91910

  • Centro de Inv. Medica de Occidente, SC

    Zapopan, Jalisco, 45116

Other trials in Mexico

Turkey (Türkiye)4 sites

  • Ankara University Medicine Hospital

    Ankara, Mamak, 06100

  • Sami Ulus Education & Research Hospital

    Ankara, 06080

  • Duzce University Medical Faculty

    Düzce, 81620

  • Ondokuz Mayis University Medical Faculty

    Samsun, 55139

Other trials in Turkey (Türkiye)

Germany3 sites

  • Praxis Dr. med. Landers

    Mayen, Rhineland-Palatinate, 56727

  • RED-Institut GmbH

    Oldenburg in Holstein, Schleswig-Holstein, 23758

  • Zentrum für klinische Studien

    Sankt Ingbert, Saarland, 66386

Other trials in Germany

France2 sites

  • Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre

    Le Kremlin-Bicêtre, 94275

  • Hopital Robert Debre

    Paris, 75019

Other trials in France

Saudi Arabia2 sites

  • King Saud University Hospital

    Riyadh, 11472

  • King Salman bin Abdulaziz Hospital - Diabetic Center

    Riyadh, 12769

Other trials in Saudi Arabia

United Kingdom2 sites

  • St James's University Hospital

    Leeds, West Yorkshire, LS9 7TF

  • Alder Hey Children's Hospital

    Liverpool, Lancashire, L14 5AB

Other trials in United Kingdom

Hungary1 site

  • Heim Pal Gyermekkorhaz

    Budapest, 1089

Other trials in Hungary

Puerto Rico1 site

  • Centro de Diabetes y Endocrinologia Pediatrica de PR

    Bayamón, PR, 00959

Other trials in Puerto Rico

About this study

Official title: 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.

Conditions
Type 2 Diabetes
Being tested
Dulaglutide, Placebo
Keywords
Pediatrics
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DulaglutideDrug

    Also called LY2189265

    Administered SC

  • PlaceboDrug

    Administered SC

Study groups in NCT02963766
Study groupRoleWhat they receive
Placebo/0.75 milligram (mg) DulaglutideExperimentalParticipants 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).
Receives: Drug: Dulaglutide; Drug: Placebo
0.75 mg DulaglutideExperimentalParticipants 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.
Receives: Drug: Dulaglutide
1.5 mg DulaglutideExperimentalParticipants 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.
Receives: Drug: Dulaglutide

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Baseline, Week 26

Secondary outcomes (15)

  1. Change From Baseline in HbA1c (Individual 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. LS mean in HbA1c was calculated using a REML based 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).

    Measured: Baseline, Week 26

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

    Fasting blood glucose is a test to determine how much glucose (sugar) is in a blood sample after an overnight fast. Least squares (LS) means were calculated using a mixed-effects model for repeated measures (MMRM) analysis and adjusted by baseline, strata, treatment, time, treatment*time, (Type III sum of squares). Variance-Covariance structure = Unstructured (for actual value) / Unstructured (for change from baseline). Strata refer to: insulin use + metformin use + baseline HbA1c group [ less than (<) 8%, greater than or equal to (>=) 8%).

    Measured: Baseline, Week 26

  3. Percentage of Participants With HbA1c ≤7.0%

    The percentage of participants was calculated by dividing the number of participants reaching target HbA1c by the total number of participants analyzed, multiplied by 100.

    Measured: Week 26

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

    BMI is an estimate of body fat based on body weight divided by height squared. LS mean were calculated using a MMRM analysis and adjusted by baseline, strata, treatment, time, treatment*time, (Type III sum of squares). Variance-Covariance structure = Unstructured (for actual value) / Unstructured (for change from baseline). Strata refer to: insulin use + metformin use + baseline HbA1c group (< 8%, >= 8%).

    Measured: Baseline, Week 26

  5. Percentage of Participants With Self-Reported Events of Hypoglycemia

    Summary and analysis of Incidence of all hypoglycemia with Plasma Glucose <54mg/dL.

    Measured: Week 26

  6. Percentage of Participants Requiring Rescue for Severe, Persistent Hyperglycemia

    Percentage of Participants Requiring Rescue for Severe, Persistent Hyperglycemia was summarized.

    Measured: Week 26

  7. Number of Participants With Adjudicated Pancreatitis

    The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

    Measured: Week 26

  8. Change From Baseline in Pancreatic Enzymes at Week 26

    Serum Amylase (total and pancreas-derived) and lipase concentrations were measured.

    Measured: Baseline, Week 26

  9. Number of Participants With Thyroid Treatment-Emergent Adverse Events

    Number of Participants with Thyroid Treatment-Emergent Adverse Events were summarized.

    Measured: Week 26

  10. Change From Baseline in Serum Calcitonin at Week 26

    Change from Baseline in Serum Calcitonin was evaluated.

    Measured: Baseline, Week 26

  11. Percentage of Participants With Allergic, Hypersensitivity Reactions

    The percentage of Participants with Allergic and hypersensitivity reactions that were considered possibly related to study drug by the investigator are presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

    Measured: Week 26

  12. Percentage of Participants With Injection Site Reactions

    The percentage of participants with at least one treatment-emergent injection site reaction is presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

    Measured: Week 26

  13. Number of Participants With Anti-Dulaglutide Antibodies

    Dulaglutide anti-drug antibodies (ADA) were assessed at baseline, Weeks 26 and 56. A participant was considered to have treatment-emergent (TE) dulaglutide ADAs if the participant had at least 1 titer that was TE relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement.

    Measured: Baseline through Week 56

  14. Pharmacokinetics (PK): Maximum Concentration of Dulaglutide at Steady-state (Cmax,ss)

    PK: Maximum Concentration of Dulaglutide at steady-state (Cmax,ss) was derived by a population pharmacokinetics approach. As part of addendum, additional PK samples were taken at week 9.

    Measured: Week 9: pre-dose,1 to 12 hours post dose and 24 to 96 hours post dose; Week 13: predose and 1 to 12 hours post dose; Week 26: predose; Week 39: up to 2 days postdose; Week 52 and Week 56: PK sample can be taken at any time during the visit

  15. PK: Area Under the Concentration Time Curve Over a 1-week Interval of Dulaglutide at Steady-State [AUC(0-168)ss]

    PK: Area Under the Concentration Time Curve over a 1-week interval of Dulaglutide at Steady-State [AUC(0-168)ss] was derived by a population pharmacokinetics approach. As part of addendum, additional PK samples were taken at week 9.

    Measured: Week 9: pre-dose,1 to 12 hours post dose and 24 to 96 hours post dose; Week 13: predose and 1 to 12 hours post dose; Week 26: predose; Week 39: up to 2 days postdose; Week 52 and Week 56: PK sample can be taken at any time during the visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2016 (estimated)
  2. Study start29 Dec 2016
  3. Primary completion12 Jun 2021
  4. Study completion12 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
154 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02963766
Sponsor's protocol ID
14171
Other IDs
H9X-MC-GBGC, 2016-000361-22, 2016
Acronym
AWARD-PEDS
Status last verified
1 Jun 2022
First submitted
10 Nov 2016
Last updated
1 Jul 2022
Data monitoring committee
Yes
Individual data sharing
Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Publications

  • 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.

    PubMed 39963952

  • 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.

    PubMed 35658022

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dulaglutide in people with Type 2 Diabetes, run by Eli Lilly and Company at 61 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 61 sites in United States, India, Brazil, Mexico, Turkey (Türkiye) and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses) at Week 26 (time frame: Baseline, Week 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02963766, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2022.

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