A Comparative Study of LY900014 With Insulin Lispro (Humalog) in Participants With Type 1 Diabetes Mellitus

Study Overview
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Brief Summary
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The purpose of this study is to evaluate a new formulation of insulin lispro, LY900014, which is a drug that lowers blood sugar. The study will look at how the body processes LY900014, and the effect of LY900014 on blood sugar levels following a standard meal. For each participant, the study will consist of 4 periods and there will be approximately 12 weeks from screening to final study follow up.

Official Title
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A Study to Evaluate the Pharmacokinetics and Glucodynamics of LY900014 Compared to Humalog® in Patients With T1DM

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Biological: LY900014
* Biological: Insulin Lispro


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are male or female participants with Type 1 Diabetes Mellitus (T1DM) for at least 1 year Have a body mass index (BMI) of 18.5 kilogram per meter square (kg/m²) to 35.0 kg/m² Have a glycated hemoglobin (HbA1c) ≤9.0% at screening Are on stable prandial insulin and basal insulin (neutral protamine Hagedorn [NPH] insulin, insulin glargine or insulin detemir) for at least 3 months before screening with a total insulin dose demand of less than or equal to (≤) 1.5 units per kilogram per day (U/kg/day) Exclusion Criteria: Are currently enrolled, or have participated within the last 30 days, in a clinical trial or any other type of medical research Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate in the study Have donated blood of more than 450 millilitre (mL) or more in the last 3 months or provided any blood donation within the last month before screening. Any significant changes in insulin regimen and/or unstable blood glucose control within the past 3 months prior to screening as assessed by the investigator. Are treated with a CSII (insulin pump)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: LY900014 Before Meal<br>Individualized dose of LY900014 administered subcutaneously (SC) immediately before meal in one of four study periods. | Biological: LY900014<br>* Administered SC<br>* Other names: Ultra-Rapid Lispro;|
| Experimental: LY900014 After Meal<br>Individualized dose of LY900014 administered SC 20 minutes after start of meal in one of four study periods. | Biological: LY900014<br>* Administered SC<br>* Other names: Ultra-Rapid Lispro;|
| Active Comparator: Insulin Lispro (Humalog) Before Meal<br>Individualized dose of insulin lispro administered SC immediately before meal in one of four study periods. | Biological: Insulin Lispro<br>* Administered SC<br>* Other names: Humalog;|
| Active Comparator: Insulin Lispro (Humalog) After Meal<br>Individualized dose of insulin lispro administered SC 20 minutes after start of meal in one of four study periods. | Biological: Insulin Lispro<br>* Administered SC<br>* Other names: Humalog;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve (AUC) | PK: Insulin Lispro AUC for Each Treatment Arm. LY900014 before and after meal and insulin lispro (Humalog) before and after meal were pooled by treatment to evaluate the overall PK of LY900014 and insulin lispro (Humalog) per protocol . | Predose, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, and 420 minutes (7 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Curve | GD: Area Under The Baseline Subtracted Glucose Concentration Curve for Each Treatment Arm | Predose, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, and 300 minutes postdose |