A Study Comparing Two Formulations of Insulin Glargine in Healthy Participants

Study Overview
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Brief Summary
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The study will aim to evaluate the following: Whether there are any differences in the way the body handles LY2963016 U-200 and LY2963016 U-100. How well-tolerated LY2963016 U-200 is compared with LY2963016 U-100. How LY2963016 U-200 affects the level of blood sugar in the body compared with LY2963016 U-100. The study will last up to 17 weeks for each participant, including initial screening and follow up.

Official Title
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Bioequivalence Study Comparing the Pharmacokinetics and Glucodynamics of LY2963016 U-200 Formulation With LY2963016 U-100 Formulation in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: LY2963016


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a body mass index (BMI) between 18.5 and 29.9 kilogram per meter square (kg/m²) Have a fasting plasma glucose less than (<) 6.0 millimoles per liter (mmol/L) (108 milligram per deciliter [mg/dL]) Have venous access sufficient to allow for blood sampling and clamp procedures per protocol Exclusion Criteria: Have known allergies to the study drug, or any components of the formulation Have donated or had a blood loss of 450 milliliter (mL) within 3 months prior to study enrollment

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 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: LY2963016 U-200 Formulation (Test)<br>LY2963016 test formulation administered as a subcutaneous (SC) injection in one of two or two of four study periods. | Drug: LY2963016<br>* Administered SC<br>|
| Experimental: LY2963016 U-100 Formulation (Reference)<br>LY2963016 reference formulation administered as a SC injection in one of two or two of four study periods. | Drug: LY2963016<br>* Administered SC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of LY2963016 U-200 Formulation and LY2963016 U-100 Formulation |  | One hour before dosing up to 48 hours following administration of study drug | 
| Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of LY2963016 U-200 Formulation and LY2963016 U-100 Formulation |  | One hour before dosing up to 48 hours following administration of study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacodynamics: Total Amount of Glucose Infused (Gtot) of LY2963016 U-200 and LY2963016 U-100 |  | One hour before dosing up to about 30 hours post clamp procedure | 
| Pharmacodynamics: Maximum Glucose Infusion Rate (Rmax) of LY2963016 U-200 and LY2963016 U-100 |  | One hour before dosing up to about 30 hours post clamp procedure |