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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 20, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE November 10, 2016
First Posted Date  ICMJE November 15, 2016
Last Update Posted Date May 20, 2019
Actual Study Start Date  ICMJE December 29, 2016
Estimated Primary Completion Date June 21, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 10, 2016)
Change from Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, Week 26 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02963766 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 10, 2016)
  • Change from Baseline in HbA1c (Individual Doses) [ Time Frame: Baseline, Week 26 ]
  • Change from Baseline in Fasting Blood Glucose (FBG) [ Time Frame: Baseline, Week 26 ]
  • Percentage of Participants with HbA1c ≤6.5% [ Time Frame: Week 26 ]
  • Change from Baseline in Body Mass Index (BMI) [ Time Frame: Baseline, Week 26 ]
  • Percentage of Participants with Self-Reported Events of Hypoglycemia [ Time Frame: Week 26 ]
  • Percentage of Participants Requiring Rescue for Severe, Persistent Hyperglycemia [ Time Frame: Week 26 ]
  • Number of Participants with Adjudicated Pancreatitis [ Time Frame: Week 26 ]
  • Change from Baseline in Pancreatic Enzymes [ Time Frame: Baseline, Week 26 ]
  • Number of Participants with Thyroid Treatment-Emergent Adverse Events [ Time Frame: Week 26 ]
  • Change from Baseline in Serum Calcitonin [ Time Frame: Baseline, Week 26 ]
  • Percentage of Participants with Allergic, Hypersensitivity and Injection Site Reactions [ Time Frame: Week 26 ]
  • Number of Participants with Anti-Dulaglutide Antibodies [ Time Frame: Baseline through Week 56 ]
  • Pharmacokinetics (PK): Maximum Concentration (Cmax) of Dulaglutide [ Time Frame: Week 13 through Week 56 ]
  • PK: Area Under the Concentration Time Curve (AUC) of Dulaglutide [ Time Frame: Week 13 through Week 56 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Dulaglutide (LY2189265) in Children and Adolescents With Type 2 Diabetes
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes
Intervention  ICMJE
  • Drug: Dulaglutide
    Administered SC
    Other Name: LY2189265
  • Drug: Placebo
    Administered SC
Study Arms  ICMJE
  • Experimental: Dose 1 Dulaglutide
    Dulaglutide given subcutaneously (SC).
    Intervention: Drug: Dulaglutide
  • Experimental: Dose 2 Dulaglutide
    Dulaglutide given SC.
    Intervention: Drug: Dulaglutide
  • Placebo Comparator: Placebo
    Placebo given SC.
    Interventions:
    • Drug: Dulaglutide
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 10, 2016)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 27, 2022
Estimated Primary Completion Date June 21, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559
Listed Location Countries  ICMJE Brazil,   Canada,   China,   France,   Germany,   Hungary,   India,   Mexico,   Puerto Rico,   Saudi Arabia,   Turkey,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02963766
Other Study ID Numbers  ICMJE 14171
H9X-MC-GBGC ( Other Identifier: Eli Lilly and Company )
2016-000361-22 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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.

Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date May 1, 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP