A Study of LY900014 Formulation in Healthy Participants

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02942654
• Collaborator: (none)
• Enrollment: 32
• Location: 1
• Arms: 2
• Duration (Days): 30
• Patients Per Site Per Month: 32.5

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 about 6 to 7 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	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: Pharmacokinetics and Glucodynamics of LY900014 Compared to Insulin Lispro Following Single-Dose Administration in Healthy Subjects
• Study Start Date: Nov 1, 2016
• Actual Primary Completion Date: Dec 1, 2016
• Actual Study Completion Date: Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LY900014 Test formulation. 15-U dose of LY900014 administered subcutaneously (SC) in one of two periods.	Drug: LY900014; Administered subcutaneously (SC); Other Names: Ultra-Rapid Lispro
Active Comparator: Insulin Lispro Reference formulation. 15-U dose of Insulin Lispro administered SC in one of two periods.	Drug: Insulin Lispro; Administered SC

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 8 Hours (AUC[0-8 Hours]) [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]

   Area Under the Concentration Versus Time Curve (AUC) was measured from time zero to 8 hours (AUC[0-8 Hours]).

Secondary Outcome Measures

1. Glucodynamics (GD): Total Amount of Glucose Infused (Gtot) [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]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 70 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 study completion)

• Have a body mass index (BMI) of 18 to 30 kilogram per square meter (kg/m²), 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

• Had blood loss of more than 450 milliliters (mL) within the last month

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: NCT02942654
• Other Study ID Numbers: 16170; I8B-MC-ITRL
• First Posted: Oct 24, 2016
• Last Update Posted: Apr 27, 2020
• Last Verified: Jan 1, 2017

• Additional relevant MeSH terms: Insulin Lispro

Study Results

Participant Flow

Pre-assignment Detail	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 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: Period 1
STARTED	16	16
COMPLETED	16	16
NOT COMPLETED	0	0
Period Title: Period 1
STARTED	16	16
COMPLETED	16	16
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Overall Study
Arm/Group Description	Each participant was administered with 15 U dose of LY900014 and Insulin Lispro.
Overall Participants	32
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	39.0 (10.1)
Sex: Female, Male (Count of Participants)
Female	3 9.4%
Male	29 90.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	32 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	32 100%
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	32 100%

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 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 subcutaneously (SC) in one of two periods.	15-U dose of Insulin Lispro administered SC in one of two periods.
Measure Participants	31	32
Geometric Mean (Geometric Coefficient of Variation) [Picomoles*hour/Liter (pmol*h/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 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 subcutaneously (SC) in one of two periods.	15-U dose of Insulin Lispro administered SC in one of two periods.
Measure Participants	32	32
Geometric Mean (Geometric Coefficient of Variation) [Milligrams (mg)]	115000 (32)	125000 (34)

Adverse Events

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 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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	LY900014		Insulin Lispro
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/32 (0%)		0/32 (0%)
Other (Not Including Serious) Adverse Events
	LY900014		Insulin Lispro
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/32 (9.4%)		7/32 (21.9%)
General disorders
Catheter site bruise	0/32 (0%)	0	2/32 (6.3%)	2
Infusion site bruising	1/32 (3.1%)	1	2/32 (6.3%)	2
Injection site erythema	2/32 (6.3%)	2	0/32 (0%)	0
Vessel puncture site pain	0/32 (0%)	0	2/32 (6.3%)	2
Vessel puncture site swelling	0/32 (0%)	0	2/32 (6.3%)	3
Nervous system disorders
Headache	0/32 (0%)	0	2/32 (6.3%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There IS 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.