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

Completed · Phase 3

Conditions studied: Type 1 Diabetes Mellitus

In brief

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).

Key facts

Study ID

NCT03740919

Run by

Eli Lilly and Company

People needed

751

Starts

2019-04-07

Expected to finish

2021-07-02

Last updated by the study team

2022-01-24

Who can join

Age: 1 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Arizona — Tucson, Arizona, United States
• Children's Hospital Los Angeles - Dept of Endocrinology — Los Angeles, California, United States
• Stanford University School of Medicine - Division of Pediatric Endocrinology & Diabetes — Palo Alto, California, United States
• Center of Excellence in Diabetes & Endocrinology — Sacramento, California, United States
• Rady Childrens Hospital - San Diego — San Diego, California, United States
• Barbara Davis Center — Aurora, Colorado, United States
• Florida Hospital — Orlando, Florida, United States
• Tallahassee Memorial HealthCare — Tallahassee, Florida, United States
• University of South Florida Diabetes & Endocrinology Center — Tampa, Florida, United States
• VanMeter Pediatric Endocrinology, P.C. — Atlanta, Georgia, United States
• St. Luke's Children's Endocrinology — Boise, Idaho, United States
• Rocky Mountain Diabetes and Osteoporosis Center — Idaho Falls, Idaho, United States
• Indiana University- Riley Children's Hospital — Indianapolis, Indiana, United States
• Iowa Diabetes and Endocrinology Research Center — West Des Moines, Iowa, United States
• Pennington Biomedical Research Center — Baton Rouge, Louisiana, United States
• Barry Reiner Clinic — Baltimore, Maryland, United States
• Joslin Diabetes Center — Boston, Massachusetts, United States
• Children's Mercy Hospital — Kansas City, Missouri, United States
• UBMD Pediatrics — Buffalo, New York, United States
• Suny Health Science Center at Syracuse — Syracuse, New York, United States
• Endocrinology Services NorthWest — Bend, Oregon, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Texas Diabetes & Endocrinology, P.A. — Austin, Texas, United States
• Texas Institute for Kidney and Endocrine Disorders — Lufkin, Texas, United States
• University of Alabama Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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