Trial Outcomes & Findings for A Study of LY900014 Formulation in Healthy Participants (NCT NCT02942654)

NCT ID: NCT02942654

Last Updated: 2020-04-27

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 32 participants
• Primary outcome timeframe: 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
• Results posted on: 2020-04-27

Participant Flow

The study consisted of two treatment periods, with a minimum of 3 days washout period between each period.

Participant milestones

Measure	Sequence 1 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).	Sequence 2 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 1 STARTED	16	16
Period 1 Received at Least 1 Dose of Study Drug	16	16
Period 1 COMPLETED	16	16
Period 1 NOT COMPLETED	0	0
Washout STARTED	16	16
Washout COMPLETED	16	16
Washout NOT COMPLETED	0	0
Period 2 STARTED	16	16
Period 2 COMPLETED	16	16
Period 2 NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of LY900014 Formulation in Healthy Participants

Baseline characteristics by cohort

Measure	Overall Study n=32 Participants Each participant was administered with 15 U dose of LY900014 and Insulin Lispro.
Age, Continuous	39.0 Years STANDARD_DEVIATION 10.1 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	32 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	32 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Singapore	32 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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

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

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

Outcome measures

Measure	LY900014 n=31 Participants 15-U dose of LY900014 administered subcutaneously (SC) in one of two periods.	Insulin Lispro n=32 Participants 15-U dose of Insulin Lispro administered SC in one of two periods.
Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 8 Hours (AUC[0-8 Hours])	2050 Picomoles*hour/Liter (pmol*h/L) Geometric Coefficient of Variation 18	1930 Picomoles*hour/Liter (pmol*h/L) Geometric Coefficient of Variation 19

SECONDARY outcome

Timeframe: 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

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

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.

Outcome measures

Measure	LY900014 n=32 Participants 15-U dose of LY900014 administered subcutaneously (SC) in one of two periods.	Insulin Lispro n=32 Participants 15-U dose of Insulin Lispro administered SC in one of two periods.
Glucodynamics (GD): Total Amount of Glucose Infused (Gtot)	115000 Milligrams (mg) Geometric Coefficient of Variation 32	125000 Milligrams (mg) Geometric Coefficient of Variation 34

Adverse Events

LY900014

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Insulin Lispro

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	LY900014 n=32 participants at risk 15-U dose of LY900014 administered subcutaneously (SC) in one of two periods.	Insulin Lispro n=32 participants at risk 15-U dose of Insulin Lispro administered SC in one of two periods.
General disorders Catheter site bruise	0.00% 0/32 All randomized participants who received at least one dose of the study drug.	6.2% 2/32 • Number of events 2 All randomized participants who received at least one dose of the study drug.
General disorders Infusion site bruising	3.1% 1/32 • Number of events 1 All randomized participants who received at least one dose of the study drug.	6.2% 2/32 • Number of events 2 All randomized participants who received at least one dose of the study drug.
General disorders Injection site erythema	6.2% 2/32 • Number of events 2 All randomized participants who received at least one dose of the study drug.	0.00% 0/32 All randomized participants who received at least one dose of the study drug.
General disorders Vessel puncture site pain	0.00% 0/32 All randomized participants who received at least one dose of the study drug.	6.2% 2/32 • Number of events 2 All randomized participants who received at least one dose of the study drug.
General disorders Vessel puncture site swelling	0.00% 0/32 All randomized participants who received at least one dose of the study drug.	6.2% 2/32 • Number of events 3 All randomized participants who received at least one dose of the study drug.
Nervous system disorders Headache	0.00% 0/32 All randomized participants who received at least one dose of the study drug.	6.2% 2/32 • Number of events 2 All randomized participants who received at least one dose of the study drug.

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place