A Phase 1 interventional study of LY900014 and Insulin Lispro in Healthy, sponsored by Eli Lilly and Company. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-16.
Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science
The purpose of this study is to evaluate a new formulation of insulin lispro, LY900014, which is a drug that lowers blood sugar. The study will look at how the body processes LY900014 and the effect of LY900014 on blood sugar levels. For each participant, the study will consist of 3 periods and will last about 51 days.
Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.
Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Female participants:
Exclusion Criteria:
15 units (U) Insulin Lispro (Humalog) administered once, subcutaneously (SC), in one of three study periods.
Drug: Insulin Lispro
7 U, and 15 U LY900014 administered once, SC, in two of three study periods.
Drug: LY900014
Administered SC
Also known as: Ultra-Rapid Lispro
Administered SC
Also known as: LY275585, Humalog
Pharmacokinetics (PK): Insulin Lispro Area Under the Serum Concentration Versus Time Curve From Time Zero to 10 Hours Postdose (AUC[0-10h])
PK: Insulin Lispro AUC(0-10h)
Time frame: Day 1: Predose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, 420, 480, 540, and 600 minutes postdose
Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot)
Gtot is the total amount of glucose infused over the duration of the clamp procedure (10 hours) for each study period.
Time frame: Day 1: Predose: -10, -20, -30 minutes; During clamp: every 2.5 to 3 minutes for the first 30 minutes; every 5 minutes for 30 to 120 minutes; every 10 minutes for 120 to 480 minutes and every 20 minutes for 480 to 600 minutes postdose
| Milestone | Sequence 1: CAB | Sequence 2: ACB | Sequence 3: ABC |
|---|---|---|---|
| Started | 5 | 5 | 5 |
| Received at least one dose of study drug | 5 | 5 | 5 |
| Completed | 5 | 5 | 5 |
| Not completed | 0 | 0 | 0 |
| Milestone | Sequence 1: CAB | Sequence 2: ACB | Sequence 3: ABC |
|---|---|---|---|
| Started | 5 | 5 | 5 |
| Completed | 5 | 5 | 5 |
| Not completed | 0 | 0 | 0 |
| Milestone | Sequence 1: CAB | Sequence 2: ACB | Sequence 3: ABC |
|---|---|---|---|
| Started | 5 | 5 | 5 |
| Completed | 5 | 5 | 5 |
| Not completed | 0 | 0 | 0 |
PK: Insulin Lispro AUC(0-10h)
| picomole * hour per Liter (pmol*h/L) | 7 U LY900014 | 15 U LY900014 | 15 U Humalog |
|---|---|---|---|
| Pharmacokinetics (PK): Insulin Lispro Area Under the Serum Concentration Versus Time Curve From Time Zero to 10 Hours Postdose (AUC[0-10h]) | 708 ± 12 | 1580 ± 11 | 1600 ± 12 |
Gtot is the total amount of glucose infused over the duration of the clamp procedure (10 hours) for each study period.
| milligram per kilogram (mg/kg) | 7 U LY900014 | 15 U LY900014 | 15 U Humalog |
|---|---|---|---|
| Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot) | 989 ± 35 | 1540 ± 40 | 1720 ± 32 |
Collected over Baseline to end of study (up to 183 days).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 7 Unit (U) LY900014 | 0/15 (0%) | 0/15 (0%) | 1/15 (6.7%) |
| 15 U LY900014 | 0/15 (0%) | 0/15 (0%) | 4/15 (26.7%) |
| 15 U Humalog | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Event | 7 Unit (U) LY900014 | 15 U LY900014 | 15 U Humalog |
|---|---|---|---|
| Blood creatine phosphokinase increasedInvestigations | 0/15 | 3/15 | 0/15 |
| Nodal rhythmCardiac disorders | 1/15 | 0/15 | 0/15 |
| Hepatic function abnormalHepatobiliary disorders | 0/15 | 1/15 | 0/15 |
| Alanine aminotransferase increasedInvestigations | 0/15 | 1/15 | 0/15 |
All enrolled participants whether or not they completed all protocol requirements.
| Age, Continuous(years) | Overall Baseline |
|---|---|
| Mean | 27.0 ± 3.7 |
| Sex: Female, Male(Participants) | Overall Baseline |
|---|---|
| Female | 0 |
| Male | 15 |
| Ethnicity (NIH/OMB)(Participants) | Overall Baseline |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 15 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Overall Baseline |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 15 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Overall Baseline |
|---|---|
| China | 15 |
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