A Study of a New Type of Insulin in Participants With Type 2 Diabetes on Insulin Injection Therapy

Study Overview
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Brief Summary
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The study will be conducted in participants with type 2 diabetes on insulin injection therapy to investigate how the body processes a test formulation of insulin lispro and the effect of the test formulation on blood sugar levels. Side effects and tolerability will be documented. The study will be conducted in two parts (Part A and Part B) to achieve its objectives. Participants are expected to enroll in both parts.

Official Title
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Pharmacokinetics, Glucodynamics, Safety, and Tolerability of a Novel Insulin Lispro Formulation in Patients With Type 2 Diabetes Mellitus on Multiple Daily Insulin Injection Therapy

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Insulin Lispro


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are male or female participants with Type 2 Diabetes Mellitus (T2DM) Are on stable prandial insulin as a multiple daily injection regimen, plus/minus basal insulin, with or without a stable dose of metformin, for at least 3 months before screening Have a body mass index (BMI) no greater than 35.0 kilogram per square meter (kg/m²) Have blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results 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 enrolled, or have participated within the last 30 days, in a clinical trial or any other type of medical research judged to be incompatible with this study Have previously completed or withdrawn from this study Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate in the study Had blood loss of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 Are treated with a continuous subcutaneous insulin infusion (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: Part A:Insulin Lispro Test<br>Individualized doses of insulin lispro test formulation administered by injection under the skin once in each of 3 periods | Drug: Insulin Lispro<br>* Administered subcutaneously (SC)<br>|
| Active Comparator: Part A:Insulin Lispro Reference<br>Individualized doses of insulin lispro reference formulation administered by injection under the skin once in each of 3 periods | Drug: Insulin Lispro<br>* Administered subcutaneously (SC)<br>|
| Experimental: Part B:Insulin Lispro Test<br>Individualized doses of insulin lispro test formulation administered by injection under the skin with each meal for 14 days | Drug: Insulin Lispro<br>* Administered subcutaneously (SC)<br>|
| Active Comparator: Part B:Insulin Lispro Reference<br>Individualized doses of insulin lispro reference formulation administered by injection under the skin with each meal for 14 days | Drug: Insulin Lispro<br>* Administered subcutaneously (SC)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| (Part A) Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Insulin Lispro | (Part A) PK: AUC of Insulin Lispro | Time 0 to 5 hours post dose for each treatment on Day 1 | 
| (Part B) PK: AUC of Insulin Lispro Glucose Following a Mixed Meal | (Part B) PK: AUC of Insulin Lispro Glucose Following a Mixed Meal | Time 0 to 5 hours post dose on Day 1 and Day 14 of study treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| (Part A) Pharmacodynamics (PD): AUC of Glucose Following a Meal | (Part A) PD: AUC of Glucose Following a Meal | Time 0 to 5 hours post meal for each treatment on Day 1 | 
| (Part B) PD: AUC of Glucose Following a Meal | (Part B) PD: AUC of Glucose Following a Meal | Time 0 to 5 hours post meal on Day1 and Day14 of study treatment |