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A Study Comparing LY900014 to Insulin Lispro (Humalog) in Children and Adolescents With Type 1 Diabetes (PRONTO-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: NCT03740919
Recruitment Status : Completed
First Posted : November 14, 2018
Results First Posted : January 24, 2022
Last Update Posted : January 24, 2022
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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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 Drug: Insulin Glargine Drug: Insulin Degludec Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 751 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
Actual Study Start Date : April 7, 2019
Actual Primary Completion Date : July 2, 2021
Actual Study Completion Date : July 2, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Insulin Lispro (Humalog)
Participants received 100 units per milliliter (U/mL) insulin lispro (Humalog) administered subcutaneously (SC), 0 to 2 minutes before each meal with once or twice daily basal insulin. Preprandial insulin doses were individualized and titrated according to protocol-defined targets.
 Drug: Insulin Lispro
Administered SC
Other Names:
  • Humalog
  • LY275585

Drug: Insulin Glargine
Administered SC

Drug: Insulin Degludec
Administered SC
Experimental: LY900014
Participants received 100 U/mL LY900014 administered SC, 0 to 2 minutes before start of the meal.
 Drug: LY900014
Administered SC
Other Name: Ultra-Rapid Lispro
Experimental: LY900014 Postmeal
Participants received 100 U/mL LY900014 administered SC, up to 20 minutes after the start of the meal.
 Drug: LY900014
Administered SC
Other Name: Ultra-Rapid Lispro


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

    Change from baseline in HbA1c was analyzed using mixed model repeated measures (MMRM) and includes fixed class effects of treatment, strata (pooled country, type of basal insulin, and age group), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. An unstructured covariance structure will be used to model the within-participant errors.

    The Efficacy estimand included data collected prior to permanent discontinuation of study drug through Week 26.



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

    Change from baseline in HbA1c postprandial was analyzed using (MMRM and includes fixed class effects of treatment, strata (pooled country, type of basal insulin, and age group), visit, and treatment-by-visit interaction, as well as the continuous, fixed covariates of baseline value. An unstructured covariance structure will be used to model the within-participant errors.

    The Efficacy estimand included data collected prior to permanent discontinuation of study drug through Week 26.


  2. Percentage of Participants With Documented Post-dose Hypoglycemic Events Within 1 and 2 Hours After the Prandial Dose [ Time Frame: Baseline through Week 26 ]
    Documented post-dose hypoglycemia <54 milligrams per deciliter (mg/dL) and ≤ 70 mg/dL that occurred 1 and 2 hours after prandial dose.

  3. Rate of Documented Post-dose Hypoglycemic Events Within 1 and 2 Hours After the Prandial Dose [ Time Frame: Baseline through Week 26 ]
    Documented post-dose hypoglycemia event is an event of blood glucose of < 54 mg/dL and ≤70 mg/dL that occurred within 1 and 2 hours after the prandial dose. The rate of documented hypoglycemia was estimated by a negative binomial regression including treatment and age group as independent variable and number of episodes as dependent variables with log (exposure/365.25 days) as the offset in the model.

  4. Percentage of Participants With Documented Hypoglycemic Events [ Time Frame: Baseline through Week 26 ]
    Documented hypoglycemia is defined as <54 mg/dL and ≤70 mg/dL, respectively.

  5. Rate of Documented Hypoglycemia Events [ Time Frame: Week 0 through Week 26 ]
    Documented hypoglycemia is defined as a hypoglycemic event of blood glucose of ≤70 mg/dL or <54 mg/dL. The rate of documented hypoglycemia was estimated by negative binomial regression including treatment and age group as independent variables and number of episodes as dependent variable with log (exposure/365.25 days) as the offset in the model.

  6. Rate of Severe Hypoglycemia [ Time Frame: Week 0 through Week 26 ]

    Severe hypoglycemia: during these episodes, participants have an altered mental status and cannot assist in their own care, may be semiconscious or unconscious, or experience coma with or without seizures, and require assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions.

    The rate of severe hypoglycemia per 100 years was calculated as: 100 times the total number of severe hypoglycemia episodes within the period divided by total exposure (in year) for all participants within the treatment group.


  7. Change From Baseline in Insulin Dose at Week 26 [ Time Frame: Baseline, Week 26 ]
    Change from baseline in insulin dose was analyzed using mixed model repeated measures (MMRM) and includes fixed class effects of treatment, strata (pooled country, type of basal insulin, age group, and HbA1c stratum (≤8.0%, >8.0%)), baseline value, visit and treatment-by-visit interaction. An unstructured covariance structure was used to model the within-participant errors.

  8. Percentage of Participants With HbA1c < 7.0% and <7.5% [ Time Frame: Week 26 ]
    Percentage of participants with HbA1c < 7.0% and <7.5% was analyzed using a longitudinal logistic regression with repeated measurements conducted by a generalized linear mixed model including independent variables of treatment, baseline HbA1c value, visit, baseline HbA1c-by-visit interaction, and treatment-by-visit interaction. An unstructured covariance structure was used.

  9. Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) Values at Week 26 [ Time Frame: Baseline, Week 26 ]
    Change from baseline in 7-point SMBG values were analyzed using MMRM and includes fixed class effects of treatment, strata (pooled country, type of basal insulin, and age group, and HbA1c stratum (≤8.0%, >8.0%)) baseline value, visit, and treatment-by-visit interaction. An unstructured covariance structure was used to model the within-participant errors.


Eligibility Criteria
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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 ≤ 9.9% 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.
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): NCT03740919


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] April 30, 2020
Statistical Analysis Plan  [PDF] January 20, 2021

More Information
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Additional Information:

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03740919    
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
Results First Posted: January 24, 2022
Last Update Posted: January 24, 2022
Last Verified: December 2021
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://vivli.org/

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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
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
 Insulin
Insulin, Globin Zinc
Insulin Glargine
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs