A Study of LY900014 in Elderly and Younger Adult Participants With Type 1 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare LY900014 with insulin lispro (Humalog) in elderly and younger adults with type 1 diabetes mellitus. Screening is required within 28 days prior to the start of the study. For each participant, the total duration of the clinical trial will be between 3 to 8 weeks.

Official Title
-----------------
Pharmacokinetics and Glucodynamics of LY900014 Compared to Insulin Lispro Following Single Dose Administration in Elderly and Younger Adults With Type 1 Diabetes Mellitus

Conditions
-----------------
Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Drug: LY900014
* Drug: Insulin Lispro


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Are male or female participants with Type 1 Diabetes Mellitus (T1DM) Have a body mass index (BMI) of 18.5 to 30.0 kilogram per meter square (kg/m²) Have a glycated hemoglobin (HbA1c) less than (<)9.0 percent (%) Have had no episodes of severe hypoglycaemia in the last 6 months Exclusion Criteria: Have a history or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (apart from T1DM), hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data Have a history of renal impairment Have a history of deep vein thrombosis of the leg or repeated episodes of deep leg vein thrombosis in first-degree relatives Have proliferative retinopathy or maculopathy and/or severe neuropathy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Elderly Adults LY900014<br>Single, subcutaneous (SC) 15-U dose of LY900014 in the elderly adult group. | Drug: LY900014<br>* Administered SC<br>* Other names: Ultra-Rapid Lispro;|
| Active Comparator: Elderly Adults Insulin Lispro<br>Single, SC 15-U dose of insulin lispro (Humalog) in in the elderly adult group. | Drug: Insulin Lispro<br>* Administered SC<br>* Other names: LY275585;|
| Experimental: Younger Adults LY900014<br>Single, SC 15-U dose of LY900014 in the younger adult group. | Drug: LY900014<br>* Administered SC<br>* Other names: Ultra-Rapid Lispro;|
| Active Comparator: Younger Adults Insulin Lispro<br>Single, SC 15-U dose of insulin lispro (Humalog) in the younger adult group. | Drug: Insulin Lispro<br>* Administered SC<br>* Other names: LY275585;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Insulin Lispro Area Under the Concentration Versus Time Curve (AUC) for Each Treatment Arm | Pharmacokinetics: Insulin lispro AUC from time zero to 10 hours postdose [AUC(0-10h)] for each treatment arm. | Day 1: Pre-dose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, 420, 480, 540, and 600 minutes post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Amount of Glucose Infused (Gtot) Over Duration of Clamp for Each Treatment Arm | Glucodynamics: Gtot is the total glucose infusion over the clamp duration (10 hours) and is used to measure the study drug action over time as measured by the euglycemic clamp procedure. | Every minute starting from the pre-dose and throughout the duration of the clamp until 10 hours post-dose |