A Study of LY900014 in Participants With Type 2 Diabetes Mellitus

Phase 1

Completed

Brief Summary: The purpose of this study is to compare LY900014 with insulin lispro (Humalog) in participants with type 2 diabetes mellitus. The study will be conducted in participants with type 2 diabetes on insulin injection therapy to investigate how the body processes LY900014 and the effect of LY900014 on blood sugar levels compared to insulin lispro (Humalog).

Screening is required within 28 days prior to the start of the study. For each participant, the total duration of the clinical trial will be between 3 and 8 weeks.

Recruitment & Eligibility

Inclusion Criteria

Are male or female participants with Type 2 Diabetes Mellitus (T2DM) 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 T2DM), 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
Have a history of renal impairment
Have a history of deep vein thrombosis of the leg or repeated episodes of deep leg vein thrombosis in first-degree relatives
Have proliferative retinopathy or maculopathy and/or severe neuropathy

Arm && Interventions

Group	Intervention	Description
LY900014	LY900014	Single, subcutaneous (SC) dose of 15 Units (U) LY900014 in one of two study periods
Insulin Lispro (Humalog)	Insulin Lispro	Single SC dose of 15 U insulin lispro (Humalog) in one of two study periods

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Insulin Lispro Area Under the Plasma Concentration Curve Zero to 10 Hours (AUC[0-10) Following Each Treatment Arm	Predose, 5 minutes (mn), 10mn, 15mn, 20mn, 25mn, 30mn, 35mn, 40mn,45 mn,50mn, 55mn, 60mn, 70mn, 90mn, 120mn, 150mn, 180mn, 240mn, 300mn, 360mn, 420mn, 480mn, 540mn, and 600 minutes(10 hours) postdose	Pharmacokinetics(PK): Insulin Lispro AUC from zero to 10 hours postdose \[AUC(0-10)\] following each treatment arm

Secondary Outcome Measures

Name	Time	Method
Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot) Over Duration of Clamp for Each Treatment Arm	Predose, every minute starting from run-in and throughout the duration of the 10 hours	Glucodynamics: Gtot is the total glucose infusion over the clamp duration (10 hours) and is used to measure the study drug action over time as measured by the euglycemic clamp procedure.

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, Nordrhein-Westfalen, Germany