A Meal Test Study of LY900014 in Participants With Type 1 Diabetes Mellitus

Study Overview
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Brief Summary
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Two forms of insulin lispro (LY900014 and Humalog®) and two forms of insulin aspart (NovoRapid® and Fiasp®) will be given to trial participants with diabetes mellitus type 1 by injection under the skin. The study will assess how fast the active ingredient (insulin lispro or insulin aspart) gets into the blood stream and how long it takes the body to remove it. A test meal will be given to trial participants to assess the course of the blood sugar lowering effect of the investigational products. The safety and tolerability of LY900014 will also be assessed. Screening is required within 14 days prior to the lead in. For each participant, the study will last up to 91 days.

Official Title
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A Mixed Meal Tolerance Test Study to Evaluate the Pharmacokinetics and Pharmacodynamics of LY900014 Compared to Humalog Following a Single Dose in Adults With Type 1 Diabetes

Conditions
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Diabetes Mellitus, Type 1

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


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 to 35.0 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

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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Accepts Healthy Volunteers

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<br>T1DM participants received a single, individualized, subcutaneous (SC) dose of LY900014. | Drug: LY900014<br>* Administered SC<br>* Other names: Ultra-Rapid Lispro;|
| Active Comparator: Insulin Lispro (Humalog®)<br>T1DM participants received a single, individualized, SC dose of insulin lispro. | Drug: Insulin Lispro<br>* Administered SC<br>* Other names: LY275585;|
| Active Comparator: Insulin Aspart (NovoRapid®)<br>T1DM participants received a single, individualized, SC dose of insulin aspart. | Drug: Insulin Aspart<br>* Administered SC<br>* Other names: NovoRapid®;|
| Active Comparator: Insulin Aspart (Fiasp®)<br>T1DM participants received a single, individualized, SC dose of insulin aspart. | Drug: Insulin Aspart<br>* Administered SC<br>* Other names: Fiasp®;|
| No Intervention: Healthy Participants<br>Healthy participants who received no study drug. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Insulin Lispro or Insulin Aspart Area Under the Concentration Curve From Zero to Seven Hours (AUC 0-7h) Following Administration of Each Study Arm | PK: Insulin Lispro or Insulin Aspart AUC(0-7h) | 0 (predose), 1, 2, 3,5,10, 15, 20, 25, 30,35, 40, 45, 50, 55,60, 70, 90, 120, 150,180, 240, 300, 360 and 420 minutes postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacodynamics (PD): Change From Baseline Area Under the Concentration Curve of Glucose Relative to a Mixed Meal Tolerance Test (MMTT) | PD: AUC(0-5h) of Glucose Relative to a Mixed Meal Tolerance Test (MMTT) | Time Frame:-30, -15, 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180, 195, 210, 225, 240, and 300 minutes postdose |