NCT03465878

A Study of LY900014 in Participants With Type 1 Diabetes Mellitus

A Study to Evaluate the Pharmacokinetics and Glucodynamics of LY900014 Compared to Humalog in Children, Adolescents, and Adults With Type 1 Diabetes Mellitus

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 6 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare LY900014 with insulin lispro (Humalog) in participants with type 1 diabetes mellitus. There are 2 parts to this study. Part A is investigating how the body processes LY900014 and the effect of LY900014 on blood sugar levels compared to insulin lispro (Humalog) when study treatment is given by subcutaneous injection. Part B of the study is investigating how the body processes LY900014 and the effect of LY900014 on blood sugar levels compared to insulin lispro (Humalog) when study treatment is given by continuous subcutaneous insulin infusion (CSII) pump. Screening is required within 28 days prior to the start of the study. For each participant, the study will last about 40 days in each part.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	LY900014	Administered via SC injection
DRUG	Insulin Lispro	Administered via SC injection

Timeline

• Start date: 2018-03-26
• Primary completion: 2019-11-14
• Completion: 2019-11-14
• First posted: 2018-03-14
• Last updated: 2020-06-18
• Results posted: 2020-06-18

Locations

2 sites across 2 countries: Canada, Germany

Regulatory

• FDA-regulated drug study