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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02963766
Recruitment Status : Completed
First Posted : November 15, 2016
Results First Posted : July 1, 2022
Last Update Posted : July 1, 2022
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Dulaglutide Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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)
Actual Study Start Date : December 29, 2016
Actual Primary Completion Date : June 12, 2021
Actual Study Completion Date : January 12, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Dulaglutide

Arms and Interventions
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Arm Intervention/treatment
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: Dulaglutide
Administered SC
Other Name: LY2189265

Drug: Placebo
Administered SC
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 Name: 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 Name: LY2189265


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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%).

  3. 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.

  4. 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%).

  5. 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.

  6. Percentage of Participants Requiring Rescue for Severe, Persistent Hyperglycemia [ Time Frame: Week 26 ]
    Percentage of Participants Requiring Rescue for Severe, Persistent Hyperglycemia was summarized.

  7. 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.

  8. 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.

  9. Number of Participants With Thyroid Treatment-Emergent Adverse Events [ Time Frame: Week 26 ]
    Number of Participants with Thyroid Treatment-Emergent Adverse Events were summarized.

  10. Change From Baseline in Serum Calcitonin at Week 26 [ Time Frame: Baseline, Week 26 ]
    Change from Baseline in Serum Calcitonin was evaluated.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02963766


Locations
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Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: 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 Documents (Full-Text)

Documents provided by Eli Lilly and Company:
Study Protocol  [PDF] October 15, 2020
Statistical Analysis Plan  [PDF] February 18, 2021

More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02963766    
Other Study ID Numbers: 14171
H9X-MC-GBGC ( Other Identifier: Eli Lilly and Company )
2016-000361-22 ( EudraCT Number )
First Posted: November 15, 2016    Key Record Dates
Results First Posted: July 1, 2022
Last Update Posted: July 1, 2022
Last Verified: June 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (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.
URL: https://www.vivli.org/
Keywords provided by Eli Lilly and Company:
Pediatrics
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Dulaglutide
Hypoglycemic Agents
Physiological Effects of Drugs