A Study of LY900014 in Healthy Chinese Participants
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ClinicalTrials.gov Identifier: NCT04049123 |
Recruitment Status :
Completed
First Posted : August 7, 2019
Results First Posted : November 16, 2021
Last Update Posted : November 16, 2021
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Condition or disease | Intervention/treatment | Phase |
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Healthy | Drug: LY900014 Drug: Insulin Lispro | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 15 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Basic Science |
Official Title: | A Study to Evaluate the Pharmacokinetics and Glucodynamics of LY900014 Following Single Dose Administration in Healthy Chinese Subjects |
Actual Study Start Date : | November 18, 2019 |
Actual Primary Completion Date : | October 23, 2020 |
Actual Study Completion Date : | October 23, 2020 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Insulin Lispro (Humalog)
15 units (U) Insulin Lispro (Humalog) administered once, subcutaneously (SC), in one of three study periods.
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Drug: Insulin Lispro
Administered SC
Other Names:
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Experimental: LY900014
7 U, and 15 U LY900014 administered once, SC, in two of three study periods.
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Drug: LY900014
Administered SC
Other Name: Ultra-Rapid Lispro |
- Pharmacokinetics (PK): Insulin Lispro Area Under the Serum Concentration Versus Time Curve From Time Zero to 10 Hours Postdose (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 ]PK: Insulin Lispro AUC(0-10h)
- Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot) [ 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 ]Gtot is the total amount of glucose infused over the duration of the clamp procedure (10 hours) for each study period.

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Are overtly healthy native Chinese males or females
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Female participants:
- Women of child-bearing potential who are abstinent or use effective methods of contraception for the entirety of the study.
- Women not of child-bearing potential who are infertile or post-menopausal
- Have a body mass index (BMI) of 18 to 28 kilograms per square meter (kg/m²)
- Are nonsmokers
- Have a fasting plasma glucose value >71 milligrams per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]) and <108 mg/dL (6.0 mmol/L)
Exclusion Criteria:
- Are currently enrolled in a clinical study, or have participated, within the last 30 days, in a clinical study involving an investigational product
- Have previously completed or withdrawn from this study or any other study investigating LY900014
- Have known allergies to LY900014 or any components of the formulation
- Have a significant history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data
- Intend to use over-the-counter or prescription medication within 7 and 14 days, respectively, prior to dosing or during the study.
- Have donated blood of more than 400 milliliters (mL) within the previous 6 months of study screening or donated more than 100 mL within the last 30 days.
- Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04049123
China, Cn-51 | |
West China Hospital Sichuan University | |
Cheng Du, Cn-51, China, 610041 |
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 |
Documents provided by Eli Lilly and Company:
Responsible Party: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT04049123 |
Other Study ID Numbers: |
16644 I8B-MC-ITRY ( Other Identifier: Eli Lilly and Company ) |
First Posted: | August 7, 2019 Key Record Dates |
Results First Posted: | November 16, 2021 |
Last Update Posted: | November 16, 2021 |
Last Verified: | October 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |
Insulin Lispro Hypoglycemic Agents Physiological Effects of Drugs |