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A Study Comparing LY900014 to Insulin Lispro (Humalog) in Children and Adolescents With Type 1 Diabetes (PRONTO-Peds)

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ClinicalTrials.gov Identifier: NCT03740919
Recruitment Status : Recruiting
First Posted : November 14, 2018
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE November 12, 2018
First Posted Date  ICMJE November 14, 2018
Last Update Posted Date September 17, 2019
Actual Study Start Date  ICMJE April 7, 2019
Estimated Primary Completion Date January 2, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 12, 2018)
Change from Baseline in Hemoglobin A1c (HbA1c) (Prandial Dosing) [ Time Frame: Baseline, Week 26 ]
Change from baseline in HbA1c (prandial dosing)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03740919 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 12, 2018)
  • Change from Baseline in HbA1c (Postprandial) [ Time Frame: Baseline, Week 26 ]
    Change from baseline in HbA1c (postprandial)
  • Rate of Documented Hypoglycemia [ Time Frame: Week 0 through Week 26 ]
    Rate of documented hypoglycemia
  • Rate of Severe Hypoglycemia [ Time Frame: Week 0 through Week 26 ]
    Rate of severe hypoglycemia
  • Change from Baseline in Insulin Dose [ Time Frame: Baseline, Week 26 ]
    Change from baseline in insulin dose
  • Proportion of Participants with HbA1c <7.5% [ Time Frame: Week 26 ]
    Proportion of participants with HbA1c <7.5%
  • Change from Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values [ Time Frame: Baseline, Week 26 ]
    Change from baseline in 7-point SMBG values
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 Comparing LY900014 to Insulin Lispro (Humalog) in Children and Adolescents With Type 1 Diabetes
Official Title  ICMJE A Prospective, Randomized, Double-Blind Comparison of LY900014 to Humalog With an Open-Label Postprandial LY900014 Treatment Group in Children and Adolescents With Type 1 Diabetes
Brief Summary The reason for this study is to compare the study drug LY900014 to insulin lispro (Humalog) in children and adolescents with type 1 diabetes (T1D).
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 1 Diabetes Mellitus
Intervention  ICMJE
  • Drug: LY900014
    Administered SC
    Other Name: Ultra-Rapid Lispro
  • Drug: Insulin Lispro
    Administered SC
    Other Names:
    • Humalog
    • LY275585
Study Arms  ICMJE
  • Experimental: LY900014
    LY900014 administered subcutaneously (SC).
    Intervention: Drug: LY900014
  • Active Comparator: Insulin Lispro
    Insulin lispro (Humalog) administered SC.
    Intervention: Drug: Insulin Lispro
  • Experimental: LY900014 Open Label
    LY900014 administered SC.
    Intervention: Drug: LY900014
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 12, 2018)
945
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2, 2021
Estimated Primary Completion Date January 2, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • T1D for at least 6 months at the screening visit.
  • Have been treated with only one of the following rapid-acting insulin analogs as part of an multiple daily injection regimen for at least the last 90 days prior to the screening visit:

    • insulin lispro U-100, or
    • insulin aspart
    • insulin glulisine or
    • fast acting insulin aspart
  • Have been treated with only one of the following basal insulins for at least the last 90 days prior to the screening visit:

    • insulin glargine U-100 (once a day [QD] or twice a day [BID]), or
    • insulin detemir U-100 (QD or BID), or
    • insulin degludec U-100 (QD)
  • Have a HbA1c value ≥6.5% and ≤9.5% at the screening visit.

Exclusion Criteria:

  • Have current hypoglycemic unawareness or have had more than 1 episode of severe hypoglycemia within 6 months prior to the screening visit.
  • Have had more than 1 emergency room visit or hospitalization due to poor glucose control within 6 months prior to the screening visit.
  • Have been on a treatment regimen that includes regular human insulin, neutral protamine Hagedorn (NPH), Afrezza® (insulin human) inhalation powder, any premixed insulins or use of diluted insulins within 90 days prior to the screening visit.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year 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 clinicaltrials.gov@lilly.com
Listed Location Countries  ICMJE Austria,   Brazil,   China,   Czechia,   Denmark,   France,   Germany,   Israel,   Italy,   Japan,   Mexico,   Poland,   Puerto Rico,   Russian Federation,   Spain,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03740919
Other Study ID Numbers  ICMJE 16698
I8B-MC-ITSB ( Other Identifier: Eli Lilly and Company )
2018-002371-18 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: 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 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: http://www.clinicalstudydatarequest.com
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 September 2019

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