A Study of Various Formulations of LY900014 in Healthy Participants

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02636361
• Collaborator: (none)
• Enrollment: 26
• Location: 1
• Arms: 5
• Duration (Months): 2
• Patients Per Site Per Month: 12.8

Study Details

Study Description

Brief Summary

This study will evaluate how quickly the body absorbs, breaks down, and gets rid of the different formulations of LY900014. This study will determine how the different formulations, when injected under the skin, will affect the blood sugar levels in the body, and how safe it is.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: LY900014; Drug: Insulin lispro (Humalog)	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 26 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Basic Science
• Official Title: Pharmacokinetics, Glucodynamics, Safety, and Tolerability of Multiple LY900014 Formulations
• Study Start Date: Dec 1, 2015
• Actual Primary Completion Date: Feb 1, 2016
• Actual Study Completion Date: Feb 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LY900014 Test B Test formulation B: Single dose of LY900014 formulation administered subcutaneously (SC) in one of five periods	Drug: LY900014; Administered subcutaneously (SC); Other Names: Ultra-Rapid Lispro
Experimental: LY900014 Test A Test formulation B: Single dose of LY900014 formulation administered SC in one of five periods	Drug: LY900014; Administered subcutaneously (SC); Other Names: Ultra-Rapid Lispro
Experimental: LY900014 Test C Test formulation C: Single dose of LY900014 formulation administered SC in one of five periods	Drug: LY900014; Administered subcutaneously (SC); Other Names: Ultra-Rapid Lispro
Experimental: LY900014 Test D Formulation D: Single dose of LY900014 formulation administered SC in one of five periods	Drug: LY900014; Administered subcutaneously (SC); Other Names: Ultra-Rapid Lispro
Active Comparator: Insulin Lispro Reference formulation: Single dose of lispro administered SC in one of five periods	Drug: Insulin lispro (Humalog); Administered SC; Other Names: Humalog LY275585

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetics (PK): Area Under The Concentration Curve (AUC 0-30mins) of Insulin Lispro [Predose,5,10,15,20,25,30,35,40,45,50,55,60,70,90,120,150,180,240,300, 360 and 420 minutes postdose]

Secondary Outcome Measures

1. Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp [Predose, every 2.5 minutes for 30 minutes, then every 5 min until 120 minutes, then every 10 minutes until 300 minutes, then every 20 minutes until 480 minutes.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Overtly healthy male or a female (not pregnant and agreeable to take birth control measures until one month after study completion)

• Must have a body mass index (BMI) of 18.0 to 30 kilogram per square meter (kg/m²) (inclusive) at the time of study screening

• Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study

• Are non-smokers or have not smoked for at least 2 months prior to entering the study, and agree not to smoke (cigars, cigarettes, or pipes) or use smokeless tobacco for the duration of the study

• Have veins suitable for easy blood collection and glucose solution infusion

Exclusion Criteria:

• Have known allergies to insulin lispro or compounds related to these drugs, or any components of the study drug

• Show signs of having an infection or infectious disease at the time of study entry

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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.	Singapore		Singapore	117597

Sponsors and Collaborators

• Eli Lilly and Company

Investigators

• Study Director: 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT02636361
• Other Study ID Numbers: 16176; I8B-FW-ITRJ
• First Posted: Dec 21, 2015
• Last Update Posted: May 13, 2020
• Last Verified: Feb 1, 2016

• Additional relevant MeSH terms: Insulin Lispro

Study Results

Participant Flow

Arm/Group Title	Sequence 1 BDCAR	Sequence 2 ADCRB	Sequence 3 ADRCB	Sequence 4 BRDAC	Sequence 5 RADCB
Arm/Group Description	B = LY900014 Test B, D, LY900014 Test D, C = LY900014 Test C, A = LY900014 Test A, R = Reference, insulin lispro (Humalog)	A = LY900014 Test A, D=LY900014 Test D, C = LY900014 Test C, R = Reference, insulin lispro (Humalog), B = LY900014 Test B	A = LY900014 Test A, D=LY900014 Test D,R = Reference, insulin lispro (Humalog), C = LY900014 Test C, B = LY900014 Test B	B = LY900014 Test B,R = Reference, insulin lispro (Humalog),D=LY900014 Test D, A = LY900014 Test A,C = LY900014 Test C	R = Reference, insulin lispro (Humalog)A = LY900014 Test A, D=LY900014 Test D, C = LY900014 Test C, B = LY900014 Test B
Period Title: Period 1
STARTED	5	6	5	5	5
Received at Least One Dose of Study Drug	5	5	5	5	4
COMPLETED	5	5	5	5	4
NOT COMPLETED	0	1	0	0	1
Period Title: Period 1
STARTED	5	5	5	5	4
COMPLETED	5	5	5	5	4
NOT COMPLETED	0	0	0	0	0
Period Title: Period 1
STARTED	5	5	5	5	4
COMPLETED	5	5	5	5	4
NOT COMPLETED	0	0	0	0	0
Period Title: Period 1
STARTED	5	5	5	5	4
COMPLETED	5	5	5	4	4
NOT COMPLETED	0	0	0	1	0
Period Title: Period 1
STARTED	5	5	5	4	4
COMPLETED	5	5	5	4	4
NOT COMPLETED	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	Overall Study
Arm/Group Description	All participants who received at least 1 dose of study drug.
Overall Participants	24
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	40.8 (11.3)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	24 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	24 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	24 100%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	0 0%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
Singapore	24 100%

Outcome Measures

1. Primary Outcome

Title	Pharmacokinetics (PK): Area Under The Concentration Curve (AUC 0-30mins) of Insulin Lispro
Time Frame	Predose,5,10,15,20,25,30,35,40,45,50,55,60,70,90,120,150,180,240,300, 360 and 420 minutes postdose

Outcome Measure Data

Analysis Population Description

Participants who received at least 1 dose of study drug and had evaluable PK data.

Arm/Group Title	LY900014 Test A	LY900014 Test B	LY900014 Test C	LY900014 Test D	Reference (Insulin Lispro, Humalog)
Arm/Group Description	LY900014 Test Formulation A. Single dose of LY900014 administered subcutaneously (SC) in one of five periods.	LY900014 Test Formulation B. Single dose of LY900014 administered subcutaneously (SC) in one of five periods.	LY900014 Test Formulation C. Single dose of LY900014 administered subcutaneously (SC) in one of five periods.	LY900014 Test Formulation D. Single dose of LY900014 administered subcutaneously (SC) in one of five periods.	A single dose of Reference (insulin lispro, Humalog) administered SC in one of five periods
Measure Participants	24	24	23	24	24
Geometric Mean (Geometric Coefficient of Variation) [picomol per hours per liter (pmol*h/L)]	245 (65)	295 (54)	251 (45)	253 (56)	120 (101)

2. Secondary Outcome

Title	Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp
Time Frame	Predose, every 2.5 minutes for 30 minutes, then every 5 min until 120 minutes, then every 10 minutes until 300 minutes, then every 20 minutes until 480 minutes.

Outcome Measure Data

Analysis Population Description

All participants who received at least 1 dose of study drug.

Arm/Group Title	LY900014 Test A	LY900014 Test B	LY900014 Test C	LY900014 Test D	Reference (Insulin Lispro, Humalog)
Arm/Group Description	LY900014 Test Formulation A: Single dose of LY900014 formulation administered subcutaneously (SC) in one of five periods.	LY900014 Test Formulation B. Single dose of LY900014 administered subcutaneously (SC) in one of five periods.	LY900014 Test Formulation C. Single dose of LY900014 administered subcutaneously (SC) in one of five periods.	LY900014 Test Formulation B. Single dose of LY900014 administered subcutaneously (SC) in one of five periods.	A single dose of Reference (insulin lispro, Humalog) administered SC in one of five periods
Measure Participants	24	24	24	24	24
Geometric Mean (Geometric Coefficient of Variation) [milligrams (mg)]	84300 (35)	91100 (35)	91300 (27)	88700 (34)	85400 (32)

Adverse Events

Arm/Group Title	Reference (Insulin Lispro, Humalog)		LY900014 Test A		LY900014 Test B		LY900014 Test C		LY900014 Test D
Arm/Group Description	Reference formulation: Single dose of lispro administered SC in one of five periods		Test formulation A: Single dose of LY900014 formulation administered subcutaneously (SC) in one of five periods		Test formulation B: Single dose of LY900014 formulation administered subcutaneously (SC) in one of five periods		Test formulation C: Single dose of LY900014 formulation administered subcutaneously (SC) in one of five periods		Test formulation D: Single dose of LY900014 formulation administered subcutaneously (SC) in one of five periods
All Cause Mortality
	Reference (Insulin Lispro, Humalog)		LY900014 Test A		LY900014 Test B		LY900014 Test C		LY900014 Test D
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/24 (0%)		0/24 (0%)		0/23 (0%)		0/24 (0%)
Serious Adverse Events
	Reference (Insulin Lispro, Humalog)		LY900014 Test A		LY900014 Test B		LY900014 Test C		LY900014 Test D
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/24 (0%)		0/24 (0%)		0/23 (0%)		0/24 (0%)
Other (Not Including Serious) Adverse Events
	Reference (Insulin Lispro, Humalog)		LY900014 Test A		LY900014 Test B		LY900014 Test C		LY900014 Test D
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/24 (4.2%)		0/24 (0%)		2/24 (8.3%)		1/23 (4.3%)		3/24 (12.5%)
General disorders
Catheter site related reaction	1/24 (4.2%)	1	0/24 (0%)	0	2/24 (8.3%)	2	1/23 (4.3%)	1	3/24 (12.5%)	4

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.