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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 : Not yet recruiting
First Posted : November 14, 2018
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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).

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Drug: LY900014 Drug: Insulin Lispro Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 945 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : March 22, 2019
Estimated Primary Completion Date : January 2, 2021
Estimated Study Completion Date : January 2, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: LY900014
LY900014 administered subcutaneously (SC).
Drug: LY900014
Administered SC

Active Comparator: Insulin Lispro
Insulin lispro (Humalog) administered SC.
Drug: Insulin Lispro
Administered SC
Other Names:
  • Humalog
  • LY275585

Experimental: LY900014 Open Label
LY900014 administered SC.
Drug: LY900014
Administered SC




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


Secondary Outcome Measures :
  1. Change from Baseline in HbA1c (Postprandial) [ Time Frame: Baseline, Week 26 ]
    Change from baseline in HbA1c (postprandial)

  2. Rate of Documented Hypoglycemia [ Time Frame: Week 0 through Week 26 ]
    Rate of documented hypoglycemia

  3. Rate of Severe Hypoglycemia [ Time Frame: Week 0 through Week 26 ]
    Rate of severe hypoglycemia

  4. Change from Baseline in Insulin Dose [ Time Frame: Baseline, Week 26 ]
    Change from baseline in insulin dose

  5. Proportion of Participants with HbA1c <7.5% [ Time Frame: Week 26 ]
    Proportion of participants with HbA1c <7.5%

  6. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT03740919


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 clinicaltrials.gov@lilly.com

  Show 107 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: NCT03740919     History of Changes
Other Study ID Numbers: 16698
I8B-MC-ITSB ( Other Identifier: Eli Lilly and Company )
2018-002371-18 ( EudraCT Number )
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 15, 2019
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 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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Eli Lilly and Company:
prandial insulin
multiple daily injections
pediatric patients
postmeal dosing

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoglycemic Agents
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Insulin Lispro
Physiological Effects of Drugs