A Study of a New LY900014 Formulation in Healthy Participants

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02525744
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 4
• Duration (Months): 2
• Patients Per Site Per Month: 12

Study Details

Study Description

Brief Summary

This study evaluates a new formulation of LY900014, a drug that lowers blood sugar. It is administered by injection under the skin of the abdomen. The study will be conducted in healthy people to investigate how quickly and how much LY900014 is absorbed and the effect of different doses of LY900014 on blood sugar levels. Side effects and tolerability will be documented. The study will last for about 8 to 9 weeks for each participant, including screening and follow up. Screening is required within 28 days prior to entering the study.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Basic Science
• Official Title: Pharmacokinetics, Glucodynamics, Safety, and Tolerability of a Novel LY900014 Formulation
• Study Start Date: Aug 1, 2015
• Actual Primary Completion Date: Oct 1, 2015
• Actual Study Completion Date: Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LY900014 7.5 Units (U) Single dose of 7.5 U LY900014 administered subcutaneously (SC) in one to two of five periods.	Drug: LY900014; Administered SC; Other Names: Ultra-Rapid Lispro
Active Comparator: Insulin Lispro Reference formulation. Single dose of Insulin Lispro administered SC in one to two of five periods.	Drug: Insulin Lispro (Humalog); Administered SC; Other Names: LY275585 Humalog
Experimental: LY900014 15 U Single dose of 15 U LY900014 administered subcutaneously (SC) in one to two of five periods.	Drug: LY900014; Administered SC; Other Names: Ultra-Rapid Lispro
Experimental: LY900014 30 U Single dose of 30 U LY900014 administered subcutaneously (SC) in one to two of five periods.	Drug: LY900014; Administered SC; Other Names: Ultra-Rapid Lispro

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetics (PK) : Insulin Lispro Area Under the Concentration Curve Zero to Infinity (AUC[0-∞]) ) [5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, and 420 minutes per period.]

Secondary Outcome Measures

1. Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp [Every 10 minutes for 30 minutes Predose, Postdose: every 2.5 minutes for 30 minutes, then every 5 minutes 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)

• Have a body mass index (BMI) of 18.5 to 30 kilogram per square meter (kg/m^2), inclusive, at screening

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

• Are nonsmokers, 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

Exclusion Criteria:

• Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study

• Have previously participated or withdrawn from this study

• Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study

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

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: NCT02525744
• Other Study ID Numbers: 15989; I8B-FW-ITRE
• First Posted: Aug 17, 2015
• Last Update Posted: May 19, 2020
• Last Verified: Oct 1, 2015

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Insulin Lispro

Study Results

Participant Flow

Arm/Group Title	Sequence 1 CBARC	Sequence 2 ACRBA	Sequence 3 BRCAB	Sequence 4 RABCR
Arm/Group Description	Participants receive single subcutaneous dose: C: 30 U LY900014 B: 15 U LY900014 A: 7.5 Units (U) LY900014 R: 15 U insulin lispro(Reference) C: 30 U LY900014 with 3 day washout between doses	Participants receive single subcutaneous dose: A: 7.5 Units (U) LY900014 C: 30 U LY900014 R: 15 U insulin lispro(Reference) B: 15 U LY900014 A: 7.5 Units (U) LY900014 with 3 day washout between doses	Participants receive single subcutaneous dose: B: 15 U LY900014 R: 15 U insulin lispro(Reference) C: 30 U LY900014 A: 7.5 Units (U) LY900014 B: 15 U LY900014 with 3 day washout between doses	Participants receive single subcutaneous dose: R: 15 U insulin lispro(Reference) A: 7.5 Units (U) LY900014 B: 15 U LY900014 C: 30 U LY900014 R: 15 U insulin lispro(Reference) with 3 day washout between doses
Period Title: Period 1
STARTED	6	6	6	6
Received at Least 1 Dose of Study Drug	6	6	5	6
COMPLETED	6	6	5	6
NOT COMPLETED	0	0	1	0
Period Title: Period 1
STARTED	6	6	5	6
Received at Least 1 Dose of Study Drug	6	6	5	6
COMPLETED	6	6	5	6
NOT COMPLETED	0	0	0	0
Period Title: Period 1
STARTED	6	6	5	6
Received at Least 1 Dose of Study Drug	6	6	5	6
COMPLETED	6	5	5	6
NOT COMPLETED	0	1	0	0
Period Title: Period 1
STARTED	6	5	5	6
Received at Least 1 Dose of Study Drug	6	5	5	6
COMPLETED	5	5	5	6
NOT COMPLETED	1	0	0	0
Period Title: Period 1
STARTED	5	5	5	6
Received at Least 1 Dose of Study Drug	4	5	5	6
COMPLETED	4	5	5	6
NOT COMPLETED	1	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	23
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	35.9 (9.7)
Sex: Female, Male (Count of Participants)
Female	4 17.4%
Male	19 82.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	23 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	22 95.7%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	1 4.3%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
Singapore	23 100%
Body Mass Index (BMI) (kilograms per meter squared (kg/m2)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilograms per meter squared (kg/m2)]	25.23 (2.27)

Outcome Measures

1. Primary Outcome

Title	Pharmacokinetics (PK) : Insulin Lispro Area Under the Concentration Curve Zero to Infinity (AUC[0-∞]) )
Time Frame	5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, and 420 minutes per period.

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	LY900014 7.5 U	LY900014 15 U	LY900014 30 U	Insulin Lispro 15 U
Arm/Group Description	Participants receive single subcutaneous dose of 7.5 Units (U) LY900014	Participants receive single subcutaneous dose of 15 Units (U) LY900014	Participants receive single subcutaneous dose of 30 U LY900014	Participants receive single subcutaneous dose of 15 U insulin lispro (Reference, Humalog)
Measure Participants	24	24	24	24
Measure PK Profiles	27	27	28	29
Geometric Mean (Geometric Coefficient of Variation) [picomol per hour per L (pmol.h/L)]	901 (17)	1890 (19)	3970 (15)	1790 (14)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Participants who received at least 1 dose of study drug and had evaluable GD profiles.

Arm/Group Title	LY900014 7.5 U	LY900014 15 U	LY900014 30 U	Insulin Lispro 15 U
Arm/Group Description	Participants receive single subcutaneous dose of 7.5 Units (U) LY900014	Participants receive single subcutaneous dose of 15 Units (U) LY900014	Participants receive single subcutaneous dose of 30 U LY900014	Participants receive single subcutaneous dose of 15 U insulin lispro (Reference, Humalog)
Measure Participants	24	24	24	24
Measure Glucodynamic (GD) Profiles	24	24	25	27
Geometric Mean (Geometric Coefficient of Variation) [milligrams (mg)]	42900 (67)	82200 (41)	122000 (35)	70700 (48)

Adverse Events

Arm/Group Title	15 U Insulin Lispro (Reference,Humalog)		LY900014 7.5 U		LY900014 15 U		LY900014 30 U
Arm/Group Description	Participants received single subcutaneous dose of 15 U insulin lispro (Reference, Humalog)		Participants received single subcutaneous dose of 7.5 U LY900014		Participants received single subcutaneous dose of 15 U LY900014		Participants received single subcutaneous dose of 30 U LY900014
All Cause Mortality
	15 U Insulin Lispro (Reference,Humalog)		LY900014 7.5 U		LY900014 15 U		LY900014 30 U
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/22 (0%)		0/22 (0%)		0/23 (0%)
Serious Adverse Events
	15 U Insulin Lispro (Reference,Humalog)		LY900014 7.5 U		LY900014 15 U		LY900014 30 U
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/22 (0%)		0/22 (0%)		0/23 (0%)
Other (Not Including Serious) Adverse Events
	15 U Insulin Lispro (Reference,Humalog)		LY900014 7.5 U		LY900014 15 U		LY900014 30 U
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/23 (13%)		3/22 (13.6%)		6/22 (27.3%)		2/23 (8.7%)
General disorders
Catheter site related reaction	0/23 (0%)	0	2/22 (9.1%)	2	2/22 (9.1%)	2	0/23 (0%)	0
Infusion site haematoma	1/23 (4.3%)	1	0/22 (0%)	0	0/22 (0%)	0	2/23 (8.7%)	2
Infusion site pain	3/23 (13%)	3	0/22 (0%)	0	2/22 (9.1%)	2	1/23 (4.3%)	1
Infusion site reaction	0/23 (0%)	0	1/22 (4.5%)	1	2/22 (9.1%)	2	0/23 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.