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

I8B-MC-ITSB -

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).

Trial Summary

Age Range
1 year - 17 years
Conditions the trial is for
Type 1 Diabetes
What the trial is testing?
Insulin Degludec, Insulin Glargine, Insulin Lispro, LY900014
Could I receive a Placebo?
No
Enrollment Goal
751
Trial Dates
Apr 7, 2019 - Jul 2, 2021
How long will I be in the trial?
The study will last about 33 weeks and may include up to 7 office visits and 9 telephone visits.
Trial Phase
III

Key Requirements

Clinical trials have inclusion and exclusion requirements to determine which individuals qualify for participation. Listed below are key requirements for this clinical trial, but there may be additional requirements to qualify.

Participants Must:

  • Pediatric participant (child or teen) must have type 1 diabetes, taking multiple daily insulin injections

  • Pediatric participant must be taking one of the following long acting insulins for at least the last 90 days: glargine, or detemir or degludec

  • Pediatric participant must be taking one of the following mealtime insulins for at least the last 90 days: lispro, or aspart or glulisine

  • Female participant who is having menstrual period must be on birth control if sexually active.

  • Pediatric participant must have a recent hemoglobin A1C value 9.9%

Participants Must Not:

  • Pediatric participant must not have had more than 1 emergency room visit or hospital stay for high or low blood sugar within the last 6 months

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