A Study of LY2963016 in Healthy Participants

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: LY2963016
Drug: Lantus

Registration Number: NCT01634165

Lead Sponsor: Eli Lilly and Company

Brief Summary: This study involves 2 single injections of LY2963016 and 2 single injections of Lantus. There will be at least 6 days between each injection.

The study will compare LY2963016 to Lantus at two different doses.

This study is approximately 10 weeks long, not including screening. Screening is required within 4 weeks of the start of the study.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 24

Inclusion Criteria

Healthy males or females
Women must be either surgically sterile, post-menopausal, or agree to use a reliable method of birth control during the study
Have a body mass index between 18.5 and 29.9 kilograms per meter squared (kg/m²)
Are nonsmokers and have not smoked for at least 6 months prior to entering the study
Have normal blood pressures and pulse rates at screening, as determined by the investigator
Have an electrocardiogram (ECG) at screening considered as within normal limits by the investigator
Have clinical laboratory test results within normal reference range for the population
Have fasting plasma glucose <110 milligrams per deciliter (mg/dL) (<6.0 micromoles per liter [mmol/L]) at screening
Have venous access sufficient to allow for blood sampling, intravenous drug administration, and clamp procedures as per the protocol
Have given written informed consent approved by Lilly and the ethical review board (ERB) governing the site

Exclusion Criteria

Are persons who have previously completed or withdrawn from this study
Are currently enrolled in or have discontinued within the last 30 days from a clinical trial involving an investigational drug or device or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
Have known allergies to insulin, its excipients, or related drugs or have history of relevant allergic reactions of any origin
Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
Show evidence of significant active neuropsychiatric disease
Show evidence of current use of known drugs of abuse or have a history of use within the past year
Have a history of first-degree relatives known to have diabetes mellitus
Show evidence of an acute infection with fever or infectious disease at the time of study entry
Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies at screening
Have positive hepatitis B surface antigens at screening
Intend to use over-the-counter medication within 7 days or prescription medication within 14 days prior to dosing (apart from vitamin/mineral supplements, occasional paracetamol, thyroid replacement, or birth control methods)
Have donated blood or had a blood loss of 450 milliliters (mL) 3 months prior to study enrollment
Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females) or are unwilling to stop alcohol consumption from 48 hours prior to each dosing until discharged from the clinical research unit (CRU)

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
0.3 U/kg LY2963016	LY2963016	Single 0.3 units/kilogram (U/kg) subcutaneous dose of LY2963016
0.3 U/kg Lantus	Lantus	Single 0.3 U/kg subcutaneous dose of Lantus
0.6 U/kg Lantus	Lantus	Single 0.6 U/kg subcutaneous dose of Lantus
0.6 U/kg LY2963016	LY2963016	Single 0.6 U/kg subcutaneous dose of LY2963016

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics: Area Under the Serum LY2963016 or Lantus Concentration-Time Curve (AUC) From Zero to Infinity [AUC(0-∞)]	Predose up to 24 hours after administration of study drug	Results for LY2936016 treatment arms provide the AUC(0-∞) data for LY2936016, while the results for Lantus treatment arms provide the AUC(0-∞) for Lantus.
Pharmacokinetics: Maximum Serum LY2963016 or Lantus Concentration (Cmax)	Predose up to 24 hours after administration of study drug

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics: Area Under the Serum Concentration-Time Curve (AUC) From Time Zero to Last Measured Concentration Value [AUC(0-tlast)] of LY2963016 or Lantus	Predose up to 24 hours after administration of study drug	Results for LY2936016 treatment arms provide the AUC(0-tlast) data for LY2936016, while the results for Lantus treatment arms provide the AUC(0-tlast) for Lantus.
Total Amount of Glucose Infused (Gtot)	Postdose up to 24 hours after administration of study drug	Gtot is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of LY2963016 or Lantus by adjusting the exogenous glucose infusion rate.
Maximum Glucose Infusion Rate (Rmax)	Postdose up to 24 hours after administration of study drug	Rmax is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of LY2963016 or Lantus by adjusting the exogenous glucose infusion rate.
Pharmacokinetics: Area Under the Serum Concentration-Time Curve From Time Zero to 24 Hours [AUC(0-24)] of LY2963016 or Lantus	Predose up to 24 hours after administration of study drug	Results for LY2936016 treatment arms provide the AUC(0-24) data for LY2936016, while the results for Lantus treatment arms provide the AUC(0-24) for Lantus.

Trial Locations

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 from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Singapore, Singapore