Trial Outcomes & Findings for A Study of LY900014 in Participants With Type 2 Diabetes Mellitus (NCT NCT03305822)

NCT ID: NCT03305822

Last Updated: 2020-05-27

Results Overview

Pharmacokinetics(PK): Insulin Lispro AUC from zero to 10 hours postdose \[AUC(0-10)\] following each treatment arm

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 38 participants
• Primary outcome timeframe: Predose, 5 minutes (mn), 10mn, 15mn, 20mn, 25mn, 30mn, 35mn, 40mn,45 mn,50mn, 55mn, 60mn, 70mn, 90mn, 120mn, 150mn, 180mn, 240mn, 300mn, 360mn, 420mn, 480mn, 540mn, and 600 minutes(10 hours) postdose
• Results posted on: 2020-05-27

Participant Flow

Participant milestones

Measure	LY900014/Humalog Participants receive a single, subcutaneous (SC) dose of LY900014 with a 3 day washout and a single subcutaneous (SC) 15 U dose of Humalog (insulin lispro)	Humalog/LY900014 Participants receive a single, subcutaneous (SC) dose of 15 U of Humalog (insulin lispro) with a 3 day washout and a single subcutaneous (SC) LY900014.
Period 1 STARTED	20	18
Period 1 Received at Least 1 Dose of Study Drug	20	18
Period 1 COMPLETED	20	18
Period 1 NOT COMPLETED	0	0
Washout STARTED	20	18
Washout COMPLETED	20	18
Washout NOT COMPLETED	0	0
Period 2 STARTED	20	18
Period 2 Received at Least 1 Dose of Study Drug	20	18
Period 2 COMPLETED	20	18
Period 2 NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of LY900014 in Participants With Type 2 Diabetes Mellitus

Baseline characteristics by cohort

Measure	Overall n=38 Participants All participants received LY900014 or 15 U Humalog in a crossover design with an approximately 3 day washout period.
Age, Continuous	60.0 years STANDARD_DEVIATION 7.9 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	38 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	0 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	38 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 Germany	38 Participants n=5 Participants
Weight	93.32 kilograms (kg) STANDARD_DEVIATION 13.03 • n=5 Participants

PRIMARY outcome

Timeframe: Predose, 5 minutes (mn), 10mn, 15mn, 20mn, 25mn, 30mn, 35mn, 40mn,45 mn,50mn, 55mn, 60mn, 70mn, 90mn, 120mn, 150mn, 180mn, 240mn, 300mn, 360mn, 420mn, 480mn, 540mn, and 600 minutes(10 hours) postdose

Population: All participants who received at least 1 dose of study drug and have measurable insulin lispro concentrations. No statistical analysis was done, per protocol.

Pharmacokinetics(PK): Insulin Lispro AUC from zero to 10 hours postdose [AUC(0-10)] following each treatment arm

Outcome measures

Measure	LY900014 n=38 Participants Participants receive a single, subcutaneous (SC) dose of 15 U LY900014.	Humalog n=38 Participants Participants receive a single, subcutaneous (SC) dose of 15 U of Humalog (insulin lispro).
Pharmacokinetics (PK): Insulin Lispro Area Under the Plasma Concentration Curve Zero to 10 Hours (AUC[0-10) Following Each Treatment Arm	1380 hour times picomol per liter (pmol*h/L) Geometric Coefficient of Variation 22	1280 hour times picomol per liter (pmol*h/L) Geometric Coefficient of Variation 24

SECONDARY outcome

Timeframe: Predose, every minute starting from run-in and throughout the duration of the 10 hours

Population: All participants who received at least 1 dose of study drug and had evaluable data.

Glucodynamics: Gtot is the total glucose infusion over the clamp duration (10 hours) and is used to measure the study drug action over time as measured by the euglycemic clamp procedure.

Outcome measures

Measure	LY900014 n=37 Participants Participants receive a single, subcutaneous (SC) dose of 15 U LY900014.	Humalog n=38 Participants Participants receive a single, subcutaneous (SC) dose of 15 U of Humalog (insulin lispro).
Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot) Over Duration of Clamp for Each Treatment Arm	749 milligram/kilogram (mg/kg) Geometric Coefficient of Variation 59	647 milligram/kilogram (mg/kg) Geometric Coefficient of Variation 70

Adverse Events

15 U LY900014

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Humalog

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	15 U LY900014 n=38 participants at risk Participants received a single, subcutaneous (SC) dose 15U LY900014.	Humalog n=38 participants at risk Participants received a single, subcutaneous (SC) dose 15 U of Humalog (insulin lispro).
Cardiac disorders Coronary artery stenosis	0.00% 0/38 • Baseline until the end of study (60 days)	2.6% 1/38 • Number of events 1 • Baseline until the end of study (60 days)

Other adverse events

Measure	15 U LY900014 n=38 participants at risk Participants received a single, subcutaneous (SC) dose 15U LY900014.	Humalog n=38 participants at risk Participants received a single, subcutaneous (SC) dose 15 U of Humalog (insulin lispro).
General disorders Vessel puncture site thrombosis	5.3% 2/38 • Number of events 2 • Baseline until the end of study (60 days)	0.00% 0/38 • Baseline until the end of study (60 days)
Nervous system disorders Headache	5.3% 2/38 • Number of events 2 • Baseline until the end of study (60 days)	5.3% 2/38 • Number of events 2 • Baseline until the end of study (60 days)

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Email: Clinicaltrials.gov@lilly.com

Results disclosure agreements

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