Trial Outcomes & Findings for A Study of Insulin Peglispro in Healthy Male Japanese Participants (NCT NCT01995526)

NCT ID: NCT01995526

Last Updated: 2018-10-19

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 11 participants
• Primary outcome timeframe: Predose and 2, 4, 8, 12, 24, 30, 36, 48, 96, 144, and 192 hours postdose
• Results posted on: 2018-10-19

Participant Flow

Participant milestones

Measure	Insulin Peglispro Single subcutaneous dose of 1.3 Units per kilogram (U/kg) insulin peglispro on Day 1.
Overall Study STARTED	11
Overall Study Received One Dose of Study Drug	11
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Insulin Peglispro Single subcutaneous dose of 1.3 Units per kilogram (U/kg) insulin peglispro on Day 1.
Overall Study Physician Decision	1

Baseline Characteristics

A Study of Insulin Peglispro in Healthy Male Japanese Participants

Baseline characteristics by cohort

Measure	Insulin Peglispro n=11 Participants Single subcutaneous dose of 1.3 U/kg insulin peglispro on Day 1.
Age, Continuous	23.8 years STANDARD_DEVIATION 3.6 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 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	11 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 Japan	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: Predose and 2, 4, 8, 12, 24, 30, 36, 48, 96, 144, and 192 hours postdose

Population: All participants who received insulin peglispro and had evaluable Cmax data.

Outcome measures

Measure	Insulin Peglispro n=10 Participants Single subcutaneous dose of 1.3 U/kg insulin peglispro on Day 1.
Pharmacokinetics: Observed Maximum Concentration (Cmax) of Insulin Peglispro	3720 picomoles/liter (pmol/L) Geometric Coefficient of Variation 32

PRIMARY outcome

Timeframe: Predose and 2, 4, 8, 12, 24, 30, 36, 48, 96, 144, and 192 hours postdose

Population: All participants who received insulin peglispro and had evaluable AUC(0-∞) data.

AUC from time zero to infinity (AUC[0-∞]) of insulin peglispro was evaluated.

Outcome measures

Measure	Insulin Peglispro n=10 Participants Single subcutaneous dose of 1.3 U/kg insulin peglispro on Day 1.
Pharmacokinetics: Area Under the Concentration Curve (AUC) of Insulin Peglispro	280000 picomoles*hours/liter (pmol*h/L) Geometric Coefficient of Variation 18

PRIMARY outcome

Timeframe: Predose and 2, 4, 8, 12, 24, 30, 36, 48, 96, 144, and 192 hours postdose

Population: All participants who received insulin peglispro and had evaluable Tmax data.

Outcome measures

Measure	Insulin Peglispro n=10 Participants Single subcutaneous dose of 1.3 U/kg insulin peglispro on Day 1.
Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of Insulin Peglispro	39.00 hours Interval 8.0 to 48.0

PRIMARY outcome

Timeframe: Predose up to 36 hours post clamp procedure

Population: All participants who received insulin peglispro and had evaluable Rmax data.

Outcome measures

Measure	Insulin Peglispro n=10 Participants Single subcutaneous dose of 1.3 U/kg insulin peglispro on Day 1.
Glucodynamics: Maximum Glucose Infusion Rate (Rmax)	1.75 milligrams/minute/kilogram (mg/min/kg) Geometric Coefficient of Variation 30

PRIMARY outcome

Timeframe: Predose up to 36 hours post clamp procedure.

Population: All participants who received insulin peglispro and had evaluable Gtot data.

Outcome measures

Measure	Insulin Peglispro n=10 Participants Single subcutaneous dose of 1.3 U/kg insulin peglispro on Day 1.
Glucodynamics: Total Amount of Glucose Infused (Gtot)	2180 milligrams/kilograms (mg/kg) Geometric Coefficient of Variation 48

Adverse Events

Insulin Peglispro

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Insulin Peglispro n=11 participants at risk Single subcutaneous dose of 1.3 U/kg insulin peglispro on Day 1.
Investigations Body temperature increased	9.1% 1/11 • Number of events 1

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

Restriction type: GT60