A Study of LY2963016 in Healthy Participants | NCT01634165

NCT01634165

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
I4L-MC-ABEM	Other Identifier	Eli Lilly and Company

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
0.3 U/kg LY2963016	Experimental	Single 0.3 units/kilogram (U/kg) subcutaneous dose of LY2963016	Drug: LY2963016
0.3 U/kg Lantus	Experimental	Single 0.3 U/kg subcutaneous dose of Lantus	Drug: Lantus
0.6 U/kg LY2963016	Experimental	Single 0.6 U/kg subcutaneous dose of LY2963016	Drug: LY2963016
0.6 U/kg Lantus	Experimental	Single 0.6 U/kg subcutaneous dose of Lantus	Drug: Lantus

Name	Type	Description	Arm Group Labels	Other Names
LY2963016	Drug	Administered subcutaneously	0.3 U/kg LY2963016 0.6 U/kg LY2963016

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pharmacokinetics: Area Under the Serum LY2963016 or Lantus Concentration-Time Curve (AUC) From Zero to Infinity [AUC(0-∞)]	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.	Predose up to 24 hours after administration of study drug
Pharmacokinetics: Maximum Serum LY2963016 or Lantus Concentration (Cmax)		Predose up to 24 hours after administration of study drug

Secondary Outcomes

Measure	Description	Time Frame
Pharmacokinetics: Area Under the Serum Concentration-Time Curve From Time Zero to 24 Hours [AUC(0-24)] of LY2963016 or Lantus	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.	Predose up to 24 hours after administration of study drug

Eligibility Module

Eligibility Criteria

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)

Name	Affiliation	Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)	Eli Lilly and Company	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
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.		Singapore		117597

Arm/Group Information

ID	Title	Description
FG000	0.3 U/kg LY, 0.6 U/kg LY, 0.3 U/kg Lantus, 0.6 U/kg Lantus	Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016 during Period 1; Single subcutaneous dose of 0.6 U/kg LY2963016 during Period 2; Single subcutaneous dose of 0.3 U/kg Lantus during Period 3; Single subcutaneous dose of 0.6 U/kg Lantus during Period 4. There was a minimum washout interval of 6 days between each period.
FG001	0.6 U/kg LY, 0.6 U/kg Lantus, 0.3 U/kg LY, 0.3 U/kg Lantus	Single subcutaneous dose of 0.6 U/kg LY2963016 during Period 1; Single subcutaneous dose of 0.6 U/kg Lantus during Period 2; Single subcutaneous dose of 0.3 U/kg LY2963016 during Period 3; Single subcutaneous dose of 0.3 U/kg Lantus during Period 4. There was a minimum washout interval of 6 days between each period.
FG002	0.3 U/kg Lantus, 0.3 U/kg LY, 0.6 U/kg Lantus, 0.6 U/kg LY	Single subcutaneous dose of 0.3 U/kg Lantus during Period 1; Single subcutaneous dose of 0.3 U/kg LY2963016 during Period 2; Single subcutaneous dose of 0.6 U/kg Lantus during Period 3; Single subcutaneous dose of 0.6 U/kg LY2963016 during Period 4. There was a minimum washout interval of 6 days between each period.
FG003	0.6 U/kg Lantus, 0.3 U/kg Lantus, 0.6 U/kg LY, 0.3 U/kg LY	Single subcutaneous dose of 0.6 U/kg Lantus during Period 1; Single subcutaneous dose of 0.3 U/kg Lantus during Period 2; Single subcutaneous dose of 0.6 U/kg LY2963016 during Period 3; Single subcutaneous dose of 0.3 U/kg LY2963016 during Period 4. There was a minimum washout interval of 6 days between each period.

Periods

Title

Milestones

Reasons Not Completed

Period 1

Type	Comment	Milestone Data
STARTED		FG0006 subjects FG0016 subjects FG0026 subjects FG0036 subjects
Received at Least 1 Dose of Study Drug		FG0006 subjects FG0016 subjects FG0026 subjects FG0036 subjects
COMPLETED		FG0006 subjects FG0016 subjects FG0026 subjects FG0036 subjects
NOT COMPLETED		FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects

Period 2

Type	Comment	Milestone Data
STARTED		FG0006 subjects FG0016 subjects FG0026 subjects FG003

Period 3

Type	Comment	Milestone Data
STARTED		FG0006 subjects FG0015 subjects FG0026 subjects FG003

Period 4

Type	Comment	Milestone Data
STARTED		FG0006 subjects FG0015 subjects FG0026 subjects FG003

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	All Participants	Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016, or 0.6 U/kg LY2963016, or 0.3 U/kg Lantus, or 0.6 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Pharmacokinetics: Area Under the Serum LY2963016 or Lantus Concentration-Time Curve (AUC) From Zero to Infinity [AUC(0-∞)]

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.

All participants who received study drug and had sufficient pharmacokinetic data to calculate AUC(0-∞). Participants were analyzed based on the treatment they received.

Geometric Mean

Geometric Coefficient of Variation

picomoles*hour per liter (pmol*h/L)

Predose up to 24 hours after administration of study drug

ID	Title	Description
OG000	0.3 U/kg LY2963016	Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	0.3 U/kg LY2963016	Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.

ID	Term
C000606659	LY2963016 insulin glargine
D000069036	Insulin Glargine

ID	Term
D049528	Insulin, Long-Acting
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones