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

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ClinicalTrials.gov Identifier: NCT02963766
Recruitment Status : Recruiting
First Posted : November 15, 2016
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 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
Estimated Primary Completion Date : June 21, 2021
Estimated Study Completion Date : January 27, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Dulaglutide

Arm Intervention/treatment
Experimental: Dose 1 Dulaglutide
Dulaglutide given subcutaneously (SC).
Drug: Dulaglutide
Administered SC
Other Name: LY2189265

Experimental: Dose 2 Dulaglutide
Dulaglutide given SC.
Drug: Dulaglutide
Administered SC
Other Name: LY2189265

Placebo Comparator: Placebo
Placebo given SC.
Drug: Dulaglutide
Administered SC
Other Name: LY2189265

Drug: Placebo
Administered SC




Primary Outcome Measures :
  1. Change from Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, Week 26 ]

Secondary Outcome Measures :
  1. Change from Baseline in HbA1c (Individual Doses) [ Time Frame: Baseline, Week 26 ]
  2. Change from Baseline in Fasting Blood Glucose (FBG) [ Time Frame: Baseline, Week 26 ]
  3. Percentage of Participants with HbA1c ≤6.5% [ Time Frame: Week 26 ]
  4. Change from Baseline in Body Mass Index (BMI) [ Time Frame: Baseline, Week 26 ]
  5. Percentage of Participants with Self-Reported Events of Hypoglycemia [ Time Frame: Week 26 ]
  6. Percentage of Participants Requiring Rescue for Severe, Persistent Hyperglycemia [ Time Frame: Week 26 ]
  7. Number of Participants with Adjudicated Pancreatitis [ Time Frame: Week 26 ]
  8. Change from Baseline in Pancreatic Enzymes [ Time Frame: Baseline, Week 26 ]
  9. Number of Participants with Thyroid Treatment-Emergent Adverse Events [ Time Frame: Week 26 ]
  10. Change from Baseline in Serum Calcitonin [ Time Frame: Baseline, Week 26 ]
  11. Percentage of Participants with Allergic, Hypersensitivity and Injection Site Reactions [ Time Frame: Week 26 ]
  12. Number of Participants with Anti-Dulaglutide Antibodies [ Time Frame: Baseline through Week 56 ]
  13. Pharmacokinetics (PK): Maximum Concentration (Cmax) of Dulaglutide [ Time Frame: Week 13 through Week 56 ]
  14. PK: Area Under the Concentration Time Curve (AUC) of Dulaglutide [ Time Frame: Week 13 through Week 56 ]


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 after taking diabetes medication.
  • 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 ≥100mmHg.
  • 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.
  • 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.

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


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

  Show 76 Study Locations
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

Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02963766     History of Changes
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
Last Update Posted: May 3, 2019
Last Verified: May 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.


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
Immunoglobulin Fc Fragments
Hypoglycemic Agents
Physiological Effects of Drugs
Immunologic Factors