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

• Status: Completed
• Trial end date: 2021-07-02
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Insulin; Insulin Lispro; Insulin, Globin Zinc

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.