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A Study of LY900014 in Healthy Chinese Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04049123
Recruitment Status : Completed
First Posted : August 7, 2019
Results First Posted : November 16, 2021
Last Update Posted : November 16, 2021
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: LY900014 Drug: Insulin Lispro Phase 1

Study Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Insulin Lispro (Humalog)
15 units (U) Insulin Lispro (Humalog) administered once, subcutaneously (SC), in one of three study periods.
 Drug: Insulin Lispro
Administered SC
Other Names:
  • LY275585
  • Humalog
Experimental: LY900014
7 U, and 15 U LY900014 administered once, SC, in two of three study periods.
 Drug: LY900014
Administered SC
Other Name: Ultra-Rapid Lispro


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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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
Criteria

Inclusion Criteria:

  • Are overtly healthy native Chinese males or females

  • 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)
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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China, Cn-51
West China Hospital Sichuan University
Cheng Du, Cn-51, China, 610041
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
  Study Documents (Full-Text)

Documents provided by Eli Lilly and Company:
Study Protocol  [PDF] February 20, 2019
Statistical Analysis Plan  [PDF] November 1, 2017

More Information
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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

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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
Additional relevant MeSH terms:
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Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs