A Study of LY900014 Formulation in Healthy Participants

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ClinicalTrials.gov Identifier: NCT02942654

Recruitment Status : Completed

First Posted : October 24, 2016

Results First Posted : April 27, 2020

Last Update Posted : April 27, 2020

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Eli Lilly and Company

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Basic Science
Condition	Healthy
Interventions	Drug: LY900014 Drug: Insulin Lispro
Enrollment	32

Participant Flow

Recruitment Details
Pre-assignment Details	The study consisted of two treatment periods, with a minimum of 3 days washout period between each period.


Arm/Group Title	Sequence 1	Sequence 2
Arm/Group Description	A single 15U dose of LY900014 or In...	A single 15U dose of Insulin Lispro...
Arm/Group Description	A single 15U dose of LY900014 or Insulin Lispro was administered subcutaneously (SC) as per the dosing schedule (Period 1: LY900014 ; Period 2: Insulin Lispro).	A single 15U dose of Insulin Lispro or LY900014 was administered subcutaneously (SC) as per the dosing schedule (Period 1: Insulin Lispro; Period 2: LY900014).
Period Title: Period 1
Started	16	16
Received at Least 1 Dose of Study Drug	16	16
Completed	16	16
Not Completed	0	0
Period Title: Washout
Started	16	16
Completed	16	16
Not Completed	0	0
Period Title: Period 2
Started	16	16
Completed	16	16
Not Completed	0	0

Baseline Characteristics

Arm/Group Title		Overall Study
Arm/Group Description		Each participant was administered w...
Arm/Group Description		Each participant was administered with 15 U dose of LY900014 and Insulin Lispro.
Overall Number of Baseline Participants		32
Baseline Analysis Population Description		...
Baseline Analysis Population Description		All randomized participants.
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	32 participants
		39.0 (10.1)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	32 participants
	Female	3
	Male	29
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	32 participants
	Hispanic or Latino	0
	Not Hispanic or Latino	32
	Unknown or Not Reported	0
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	32 participants
	American Indian or Alaska Native	0
	Asian	32
	Native Hawaiian or Other Pacific Islander	0
	Black or African American	0
	White	0
	More than one race	0
	Unknown or Not Reported	0
Region of Enrollment Measure Type: Count of Participants Unit of measure: Participants
Singapore	Number Analyzed	32 participants
Singapore		32

Outcome Measures

1.Primary Outcome


Title	Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 8 Hours (AUC[0-8 Hours])
Description	Area Under the Concentration Versus Time Curve (AUC) was measured from...
Description	Area Under the Concentration Versus Time Curve (AUC) was measured from time zero to 8 hours (AUC[0-8 Hours]).
Time Frame	Predose (0), 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 210, 240, 300, 330, 360, 420, and 480 minutes, post dose

Outcome Measure Data

Analysis Population Description

All randomized participants who receive at least 1 dose of study drug and have measurable PK data.


Arm/Group Title	LY900014	Insulin Lispro
Arm/Group Description:	15-U dose of LY900014 administered ...	15-U dose of Insulin Lispro adminis...
Arm/Group Description:	15-U dose of LY900014 administered subcutaneously (SC) in one of two periods.	15-U dose of Insulin Lispro administered SC in one of two periods.
Overall Number of Participants Analyzed	31	32
Geometric Mean (Geometric Coefficient of Variation) Unit of Measure: Picomoleshour/Liter (pmolh/L)
	2050 (18%)	1930 (19%)

2.Secondary Outcome


Title	Glucodynamics (GD): Total Amount of Glucose Infused (Gtot)
Description	Gtot is used to measure the study drug action over time as measured by...
Description	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 LY900014 or Insulin Lispro by adjusting the exogenous glucose infusion rate. Data presented were adjusted by the body weight.
Time Frame	2.5 minutes for the first 30 minutes, then every 5 minutes until 120 minutes postdose, and then every 10 minutes until 480 minutes postdose

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and have evaluable glucodynamic data.


Arm/Group Title	LY900014	Insulin Lispro
Arm/Group Description:	15-U dose of LY900014 administered ...	15-U dose of Insulin Lispro adminis...
Arm/Group Description:	15-U dose of LY900014 administered subcutaneously (SC) in one of two periods.	15-U dose of Insulin Lispro administered SC in one of two periods.
Overall Number of Participants Analyzed	32	32
Geometric Mean (Geometric Coefficient of Variation) Unit of Measure: Milligrams (mg)
	115000 (32%)	125000 (34%)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	All randomized participants who received at least one dose of the study drug.

Arm/Group Title	LY900014		Insulin Lispro
Arm/Group Description	15-U dose of LY900014 administered ...		15-U dose of Insulin Lispro adminis...
Arm/Group Description	15-U dose of LY900014 administered subcutaneously (SC) in one of two periods.		15-U dose of Insulin Lispro administered SC in one of two periods.
All-Cause Mortality
	LY900014		Insulin Lispro
	Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--
Serious Adverse Events Serious Adverse Events
	LY900014		Insulin Lispro
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/32 (0.00%)		0/32 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	LY900014		Insulin Lispro
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/32 (9.38%)		7/32 (21.88%)
General disorders
Catheter site bruise ^† 1	0/32 (0.00%)	0	2/32 (6.25%)	2
Infusion site bruising ^† 1	1/32 (3.13%)	1	2/32 (6.25%)	2
Injection site erythema ^† 1	2/32 (6.25%)	2	0/32 (0.00%)	0
Vessel puncture site pain ^† 1	0/32 (0.00%)	0	2/32 (6.25%)	2
Vessel puncture site swelling ^† 1	0/32 (0.00%)	0	2/32 (6.25%)	3
Nervous system disorders
Headache ^† 1	0/32 (0.00%)	0	2/32 (6.25%)	2
† Indicates events were collected by systematic assessment 1 Term from vocabulary, MedDRA 19.1

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Chief Medical Officer
Organization:	Eli Lilly and Company
Phone:	800-545-5979

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Leohr J, Dellva MA, Carter K, LaBell E, Linnebjerg H. Ultra Rapid Lispro (URLi) Accelerates Insulin Lispro Absorption and Insulin Action vs Humalog(R) Consistently Across Study Populations: A Pooled Analysis of Pharmacokinetic and Glucodynamic Data. Clin Pharmacokinet. 2021 Nov;60(11):1423-1434. doi: 10.1007/s40262-021-01030-0. Epub 2021 May 27.

Layout table for additonal information

Responsible Party:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT02942654
Other Study ID Numbers:	16170 I8B-MC-ITRL ( Other Identifier: Eli Lilly and Company )
First Submitted:	October 21, 2016
First Posted:	October 24, 2016
Results First Submitted:	April 15, 2020
Results First Posted:	April 27, 2020
Last Update Posted:	April 27, 2020

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