A Comparative Study of LY900014 With Insulin Lispro (Humalog) in Participants With Type 2 Diabetes Mellitus (T2DM)

Phase 1

Completed

Brief Summary: The purpose of this study is to evaluate a new formulation of insulin lispro, LY900014, which is a drug that lowers blood sugar. The study will look at how the body processes LY900014, and the effect of LY900014 on blood sugar levels following a standard meal. For each participant, the study will consist of 4 periods and will last approximately 12 weeks from screening to final study follow up.

Recruitment & Eligibility

Inclusion Criteria

Have a body mass index (BMI) of 18.5 kilogram per meter square (kg/m²) to 40.0 kg/m²
Have a glycated hemoglobin (HbA1c) less than or equal to (≤)9.0%
Have a fasting C-peptide ≤1.0 nanomole per liter (nmol/L)
Are on stable prandial insulin and basal insulin (neutral protamine Hagedorn [NPH] insulin, insulin glargine or insulin detemir) with or without a stable dose of metformin for at least 3 months before screening

Exclusion Criteria

Are currently enrolled, or have participated within the last 30 days, in a clinical trial or any other type of medical research
Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate in the study
Have donated blood of more than 450 millilitre (mL) or more in the last 3 months or provided any blood donation within the last month before screening
Any significant changes in insulin regimen and/or unstable blood glucose control within the past 3 months prior to screening as assessed by the investigator
Are treated with a CSII (insulin pump)
Require daily insulin treatment greater than (>)1.2 units per kilogram per body weight (U/kg/body weight)

Arm && Interventions

Group	Intervention	Description
Insulin Lispro (Humalog) Before Meal	Insulin Lispro	Individualized dose of insulin lispro administered SC immediately before meal in one of four study periods.
LY900014 Before Meal	LY900014	Individualized dose of LY900014 administered subcutaneously (SC) immediately before meal in one of four study periods.
Insulin Lispro (Humalog) After Meal	Insulin Lispro	Individualized dose of insulin lispro administered SC 20 minutes after start of meal in one of four study periods.
LY900014 After Meal	LY900014	Individualized dose of LY900014 administered SC 20 minutes after start of meal in one of four study periods.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve Zero to Seven Hours (AUC0-7hr)	Predose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, and 420 minutes (7 hours) postdose	PK: Insulin Lispro AUC for Each Treatment Arm. PK: Insulin Lispro AUC for Each Treatment Arm. LY900014 before and after meal and insulin lispro (Humalog) before and after meal were pooled by treatment to evaluate the overall PK of LY900014 and insulin lispro (Humalog) per protocol .

Secondary Outcome Measures

Name	Time	Method
Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Curve (BGΔAUC) for Each Treatment Arm	-30, -15, 0, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180, 195, 210, 225, 240, and 300 minutes post-meal	GD: Area Under the Baseline Subtracted Glucose Concentration Curve (BGΔAUC) for Each Treatment Arm

Locations (1): For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
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Neuss, Germany

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