A Study of a Novel Insulin Lispro Formulation in Participants With Type 1 Diabetes Mellitus Using Insulin Pumps

Study Overview
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Brief Summary
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This study evaluates a new test formulation of a glucose lowering drug, insulin lispro, delivered by an insulin pump continuously under the skin. The study will be conducted in participants with type 1 diabetes mellitus to investigate how the human body processes the new test formulation and its effect on blood sugar levels when it is delivered via an insulin pump. Side effects and tolerability will be documented. The study will last about 4 to 11 weeks, including screening, lead-in and follow up. Screening is required within 28 days prior to entering the study.

Official Title
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Pharmacokinetics, Glucodynamics, Safety, and Tolerability of a Novel Insulin Lispro Formulation 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: Insulin Lispro


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female participants with Type 1 Diabetes Mellitus (T1DM) who are receiving insulin therapy via an approved insulin pump Have a body mass index (BMI) of 18.5 to 33 kilogram per square meter (kg/m²), inclusive, at screening Have blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study Have had no episodes of severe hypoglycemia in the past 6 months (requiring assistance in treatment by a second party) Have venous access sufficient to allow for blood sampling Have provided written consent and are willing to follow study procedures and commit to the study duration Exclusion Criteria: Are currently participating in or completed a clinical trial within the last 30 days from a clinical trial or any other type of medical research judged to be incompatible with this study Have previously participated or withdrawn from this study Have or used to have health problems, laboratory test results, blood pressure or ECG readings that, in the opinion of the doctor, could make it unsafe to participate in the study Had blood loss of more than 500 milliliters (mL) within the last month

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Insulin Lispro - Test Formulation<br>Novel formulation of insulin lispro delivered via an insulin pump as a continuous infusion under the skin, with intermittent bolus doses during meals for two 3-day periods | Drug: Insulin Lispro<br>* Administered subcutaneously (SC)<br>* Other names: Humalog;|
| Active Comparator: Insulin Lispro - Reference Formulation<br>Marketed formulation of insulin lispro delivered via an insulin pump as a continuous infusion under the skin, with intermittent bolus doses during meals for two 3-day periods | Drug: Insulin Lispro<br>* Administered subcutaneously (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): Area under the Concentration Curve (AUC) of Insulin Lispro | PK: AUC of Insulin Lispro | Time 0 to 5 hours post dose on Day 1 and Day 3 of each study period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacodynamics (PD): AUC of Glucose Following a Meal | PD: AUC of Glucose Following a Meal | Time 0 to 5 hours post meal on Day 1 and Day 3 of each of study period |