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A Study of LY900014 in Healthy Chinese Participants

NCT ID: NCT04049123

Last Updated: 2021-11-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-18

Study Completion Date

2020-10-23

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Insulin Lispro (Humalog)

15 units (U) Insulin Lispro (Humalog) administered once, subcutaneously (SC), in one of three study periods.

Group Type ACTIVE_COMPARATOR

Insulin Lispro

Intervention Type DRUG

Administered SC

LY900014

7 U, and 15 U LY900014 administered once, SC, in two of three study periods.

Group Type EXPERIMENTAL

LY900014

Intervention Type DRUG

Administered SC

Interventions

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LY900014

Administered SC

Intervention Type DRUG

Insulin Lispro

Administered SC

Intervention Type DRUG

Other Intervention Names

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Ultra-Rapid Lispro LY275585 Humalog

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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West China Hospital Sichuan University

Chengdu, Cn-51, China

Site Status

Countries

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China

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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I8B-MC-ITRY

Identifier Type: OTHER

Identifier Source: secondary_id

16644

Identifier Type: -

Identifier Source: org_study_id