Active not recruiting

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

I8B-MC-ITSB - ClinicalTrials.gov - NCT03740919

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).
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.
Email
Active not recruiting

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

I8B-MC-ITSB - ClinicalTrials.gov - NCT03740919

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).
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.
Email

Key Requirements

Age :

1-17

Sex:

All

Key Requirements

Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.

Age

1-17

Sex

All

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

Trial Summary

Conditions the trial is for

Type 1 Diabetes

What the trial is testing?

LY900014, Insulin Lispro

Could I receive a Placebo?

no

Enrollment Goal

945

Trial Dates

April 2019 - July 2021

Trial Phase

3

Enter your postal code to find the nearest site

Key Requirements

Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.

Age

1-17

Sex

All

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

Trial Summary

Conditions the trial is for

Type 1 Diabetes

What the trial is testing?

LY900014, Insulin Lispro

Could I receive a Placebo?

no

Enrollment Goal

945

Trial Dates

April 2019 - July 2021

Trial Phase

3

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Trial Locations

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Type 1 Diabetes Resources

Clinical Trial Participation: What to Expect

Clinical Trial Participation: What to Expect

A clinical trial is a scientific study in people that helps to determine if and how a drug or therapy works. These can also be called clinical studies, or clinical research. Clinical research helps us answer specific questions about an investigational drug , such as: Is it effective? Is it more effective than another established treatment? Is it safe and/or what are its side effects?