A Study of LY900027 Given by Insulin Pump to Participants With Type 1 Diabetes Mellitus

Lilly

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 1

Treatments: Drug: LY900027; Drug: Insulin Lispro

Study type: Interventional

Funder types: Industry

Identifiers

NCT04161976

17489

2019-002318-37 (EudraCT Number)

J2H-MC-IUAA (Other Identifier)

Details and patient eligibility

About

The main purpose of this study is to learn more about a new formulation of insulin lispro when given by an insulin pump to participants with type 1 diabetes mellitus. The study will investigate how the body processes the drug and how the drug affects the body. Information about side effects will be collected. The study will last from six to 12 weeks for each participant.

Enrollment: 20 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Diagnosis of T1DM for at least 1 year
• Fasting C-peptide ≤0.30 nanomoles per liter (nmol/L)
• Bbody mass index between 18.5 and 33.0 kilograms per square meter (kg/m²)
• Participants should have a glycated hemoglobin of ≤9.0% at screening

Exclusion Criteria:

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 2 patient groups

LY900027

Experimental group

Description:

LY900027 administered to participants with type 1 diabetes mellitus (T1DM) using continuous subcutaneous insulin infusion (CSII) in one of two dosing periods.

Treatment:

Drug: LY900027

Insulin Lispro

Active Comparator group

Description:

Insulin lispro administered to participants with T1DM using CSII in one of two dosing periods.

Treatment:

Drug: Insulin Lispro