NCT05262387

A Study of LY900014 (Lyumjev) Versus Insulin Lispro (Humalog) in Participants With Type 1 Diabetes

Effectiveness of a Basal Rate Reduction With LyumjevTM Versus Humalog® on the Protection From Exercise-Induced Hypoglycemia in Individuals With Type 1 Diabetes on Continuous Subcutaneous Insulin Infusion

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This study will be conducted in participants with type 1 diabetes mellitus on continuous subcutaneous insulin infusion (CSII) or pump therapy to evaluate the effect of LY900014 (Lyumjev) on blood sugar levels during exercise using different approaches on basal rate reduction and following a test meal compared to insulin lispro (Humalog). The study may last up to approximately 10 weeks and may include up to 7 visits.

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DRUG	Lyumjev with 50% basal rate reduction	Administered SC.
DRUG	Humalog with 50% basal rate reduction	Administered SC.
DRUG	Humalog with 100% basal rate reduction	Administered SC.
DRUG	Lyumjev with 100% basal rate reduction	Administered SC.

Timeline

• Start date: 2022-02-14
• Primary completion: 2023-03-07
• Completion: 2023-03-07
• First posted: 2022-03-02
• Last updated: 2024-09-03
• Results posted: 2024-09-03

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study