A Study of LY900014 in Healthy Chinese Participants

A Study to Evaluate the Pharmacokinetics and Glucodynamics of LY900014 Following Single Dose Administration in Healthy Chinese Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: LY900014; Drug: Insulin Lispro

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Cn-51
    • Cheng Du, Cn-51, China, 610041
      • West China Hospital Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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• Have previously completed or withdrawn from this study or any other study investigating LY900014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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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: Humalog; LY275585
EXPERIMENTAL: LY900014; 7 U, and 15 U LY900014 administered once, SC, in two of three study periods.	Drug: LY900014; Administered SC; Other Names: Ultra-Rapid Lispro

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 18, 2019
• Primary Completion (ACTUAL): October 23, 2020
• Study Completion (ACTUAL): October 23, 2020

Study Registration Dates

• First Submitted: August 6, 2019
• First Submitted That Met QC Criteria: August 6, 2019
• First Posted (ACTUAL): August 7, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 16, 2021
• Last Update Submitted That Met QC Criteria: October 18, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Insulin Lispro
• Other Study ID Numbers: 16644; I8B-MC-ITRY (OTHER: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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