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

Study Overview
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Brief Summary
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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.

Official Title
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A Study to Assess the Pharmacokinetics, Glucodynamics, Safety, and Tolerability of LY900027 in Patients With Type 1 Diabetes Mellitus on Continuous Subcutaneous Insulin Infusion Therapy

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Drug: LY900027
* Drug: Insulin Lispro


Participation Criteria
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Eligibility Criteria
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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:

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY900027<br>LY900027 administered to participants with type 1 diabetes mellitus (T1DM) using continuous subcutaneous insulin infusion (CSII) in one of two dosing periods. | Drug: LY900027<br>* LY900027 administered to participants with T1DM using CSII.<br>|
| Active Comparator: Insulin Lispro<br>Insulin lispro administered to participants with T1DM using CSII in one of two dosing periods. | Drug: Insulin Lispro<br>* Insulin lispro administered to participants with T1DM using CSII.<br>* Other names: LY275585;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Pharmacokinetics (PK): Area Under the Insulin Lispro Curve (AUC) 0 to 5 hours after Bolus Administration Prior to a Mixed Meal Tolerance Text (MMTT) | PK: AUC after Bolus Administration Prior to a MMTT | Day 1 through Day 10 in each dosing period | 
| PK: Maximum Observed Insulin Lispro Concentration (Cmax) | PK: C PK: Cmax | Day 1 through Day 10 in each dosing period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacodynamics (PD): Incremental Area Under the Plasma Glucose Curve Above Baseline Between 0-5 hours After Bolus Infusion | PD: Incremental Area Under the Plasma Glucose Curve Above Baseline Between 0-5 hours After Bolus Infusion | Day 1 through Day 10 in each dosing period | 
| PD: Total Daily Insulin Dose | PD: Total Daily Insulin Dose | Day 1 through Day 10 in each dosing period | 
| Duration Until Catheter Failure | Duration Until Catheter Failure | Day -1 through Day 10 in each dosing period |