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

June 7, 2022 updated by: Eli Lilly and Company

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
154

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 04022-001
        • UNIFESP - Escola Paulista de Medicina
    • RJ
      • Rio de Janeiro, RJ, Brazil, 20211-340
        • Instituto Estadual de Diabetes e Endocrinologia
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90430-001
        • Centro de Pesquisas em Diabetes
      • Porto Alegre, Rio Grande Do Sul, Brazil, 91350-200
        • Instituto da Crianca com Diabetes
    • SP
      • São Paulo, SP, Brazil, 01228-200
        • CPCLIN
      • São Paulo, SP, Brazil, 05403-000
        • Hospital da Clinicas da Faculdade de Medicina da USP
    • Sao Paulo
      • Campinas, Sao Paulo, Brazil, 13034-685
        • Hospital PUC-Campinas
    • São Paulo
      • Ribeirão Preto, São Paulo, Brazil, 14051-140
        • Hospital das Clinicas da FMRP
  • France
      • Le Kremlin Bicetre, France, 94275
        • Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
      • Paris, France, 75019
        • Hopital Robert Debre
  • Germany
    • Rheinland-Pfalz
      • Mayen, Rheinland-Pfalz, Germany, 56727
        • Praxis Dr. med. Landers
    • Saarland
      • Sankt Ingbert, Saarland, Germany, 66386
        • Zentrum für klinische Studien
    • Schleswig Holstein
      • Oldenburg in Holstein, Schleswig Holstein, Germany, 23758
        • Red-Institut GmbH
  • Hungary
      • Budapest, Hungary, 1089
        • Heim Pál Gyermekkórház
  • India
    • Delhi
      • New Delhi, Delhi, India, 110060
        • Sir Ganga Ram Hospital
    • Gujarat
      • Ahmedabad, Gujarat, India, 380007
        • Dr Jivraj Mehta Smarak Health Foundation Bakeri Medical Research Centre
    • Karmnataka
      • Bangalore, Karmnataka, India, 560017
        • Manipal Hospital
    • Karnataka
      • Bangalore, Karnataka, India, 560054
        • M S Ramaiah Medical College Hospital
    • Maharashtra
      • Pune, Maharashtra, India, 411004
        • Deenanath Mangeshkar Hospital & Research Centre
    • Punjab
      • Chandigarh, Punjab, India, 160012
        • Post Graduate Institute of Medical Education & Research
    • Uttar Pradesh
      • Varanasi, Uttar Pradesh, India, 221005
        • Banaras Hindu University - BHU
    • West Bengal
      • Kolkata, West Bengal, India, 700054
        • Apollo Gleneagles Hospitals Kolkata
      • Kolkata, West Bengal, India, 700017
        • Park Clinic
  • Mexico
      • Puebla, Mexico, 72190
        • Hospital Angeles Puebla
      • Veracruz, Mexico, 91910
        • ARKE Estudios Clínicos S.A. de C.V.
    • Federal District
      • Mexico City, Federal District, Mexico, 03810
        • Health Pharma Professional Research, S.A. de C.V.
    • Jalisco
      • Zapopan, Jalisco, Mexico, 45116
        • Centro de Inv. Medica de Occidente, SC
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64710
        • Centro Medico San Francisco
    • Tamaulipas
      • Tampico, Tamaulipas, Mexico, 89249
        • Cli-nica Hospital Cemain
  • Puerto Rico
      • Bayamon, Puerto Rico, 00959
        • Centro de Diabetes y Endocrinologia Pediatrica de PR
  • Saudi Arabia
      • Riyadh, Saudi Arabia, 11472
        • King Saud University Hospital
      • Riyadh, Saudi Arabia, 12769
        • King Salman bin Abdulaziz Hospital - Diabetic Center
  • Turkey
      • Ankara, Turkey, 06080
        • Sami Ulus Education & Research Hospital
      • Duzce, Turkey, 81620
        • Duzce University Medical Faculty
      • Samsun, Turkey, 55139
        • Ondokuz Mayis University Medical Faculty
    • Mamak
      • Ankara, Mamak, Turkey, 06100
        • Ankara University Medicine Hospital
  • United Kingdom
    • Lancashire
      • Liverpool, Lancashire, United Kingdom, L14 5AB
        • Alder Hey Children's Hospital
    • West Yorkshire
      • Leeds, West Yorkshire, United Kingdom, LS9 7TF
        • St James's University Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama Birmingham
    • Arizona
      • Tucson, Arizona, United States, 85724
        • University of Arizona
    • California
      • Anaheim, California, United States, 92805
        • Advanced Research Center
      • Los Angeles, California, United States, 90027
        • Division of Endocrinology, Diabetes, and Metabolism
      • Orange, California, United States, 92868
        • Childrens Hospital of Orange County
      • Sacramento, California, United States, 95821
        • Center of Excellence in Diabetes & Endocrinology
      • San Diego, California, United States, 92123
        • Rady Childrens Hospital - San Diego
      • San Jose, California, United States, 95148
        • JC Cabaccan
      • Vallejo, California, United States, 94592
        • Touro University
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Children's National Medical Center
    • Florida
      • Orlando, Florida, United States, 32803
        • Florida Center for Endocrinology & Metabolism
    • Idaho
      • Boise, Idaho, United States, 83712
        • St. Luke's Regional Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois at Chicago
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Health Hospital
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808-4124
        • Pennington Biomedical Research Center
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Children's Mercy Hospital
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • ECU Pediatric Specialty Care
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Childrens Hospital Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia
      • Pittsburgh, Pennsylvania, United States, 15224
        • Childrens Hospital of Pittsburgh
    • Washington
      • Seattle, Washington, United States, 98105
        • Seattle Children's Hospital Research Foundation
      • Tacoma, Washington, United States, 98405
        • MultiCare Health System
    • West Virginia
      • Charleston, West Virginia, United States, 25302
        • CAMC Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

10 years to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Placebo/0.75 milligram (mg) Dulaglutide
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: Placebo
Administered SC
Drug: Dulaglutide
Administered SC
Other Names:
  • LY2189265
EXPERIMENTAL: 0.75 mg Dulaglutide
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
Administered SC
Other Names:
  • LY2189265
EXPERIMENTAL: 1.5 mg Dulaglutide
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
Administered SC
Other Names:
  • LY2189265

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Hemoglobin A1c (HbA1c) (Pooled Doses) at Week 26
Time Frame: Baseline, 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in HbA1c (Individual Doses) at Week 26
Time Frame: Baseline, 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).
Baseline, Week 26
Change From Baseline in Fasting Blood Glucose (FBG) at Week 26
Time Frame: Baseline, 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%).
Baseline, Week 26
Percentage of Participants With HbA1c ≤7.0%
Time Frame: Week 26
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.
Week 26
Change From Baseline in Body Mass Index (BMI) at Week 26
Time Frame: Baseline, 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%).
Baseline, Week 26
Percentage of Participants With Self-Reported Events of Hypoglycemia
Time Frame: Week 26
Summary and analysis of Incidence of all hypoglycemia with Plasma Glucose <54mg/dL.
Week 26
Percentage of Participants Requiring Rescue for Severe, Persistent Hyperglycemia
Time Frame: Week 26
Percentage of Participants Requiring Rescue for Severe, Persistent Hyperglycemia was summarized.
Week 26
Number of Participants With Adjudicated Pancreatitis
Time Frame: Week 26
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.
Week 26
Change From Baseline in Pancreatic Enzymes at Week 26
Time Frame: Baseline, Week 26
Serum Amylase (total and pancreas-derived) and lipase concentrations were measured.
Baseline, Week 26
Number of Participants With Thyroid Treatment-Emergent Adverse Events
Time Frame: Week 26
Number of Participants with Thyroid Treatment-Emergent Adverse Events were summarized.
Week 26
Change From Baseline in Serum Calcitonin at Week 26
Time Frame: Baseline, Week 26
Change from Baseline in Serum Calcitonin was evaluated.
Baseline, Week 26
Percentage of Participants With Allergic, Hypersensitivity Reactions
Time Frame: Week 26
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.
Week 26
Percentage of Participants With Injection Site Reactions
Time Frame: Week 26
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.
Week 26
Number of Participants With Anti-Dulaglutide Antibodies
Time Frame: Baseline through Week 56
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.
Baseline through Week 56
Pharmacokinetics (PK): Maximum Concentration of Dulaglutide at Steady-state (Cmax,ss)
Time Frame: 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
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.
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
PK: Area Under the Concentration Time Curve Over a 1-week Interval of Dulaglutide at Steady-State [AUC(0-168)ss]
Time Frame: 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
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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 29, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 12, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 12, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 10, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 15, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 1, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 14171
  • H9X-MC-GBGC (OTHER: Eli Lilly and Company)
  • 2016-000361-22 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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