A Study of LY900014 in Healthy Chinese Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Insulin Lispro; Drug: LY900014

Study type: Interventional

Funder types: Industry

Identifiers

NCT04049123

I8B-MC-ITRY (Other Identifier)

16644

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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• Have previously completed or withdrawn from this study or any other study investigating LY900014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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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15 participants in 2 patient groups

Insulin Lispro (Humalog)

Active Comparator group

Description:

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

Treatment:

Drug: Insulin Lispro

LY900014

Experimental group

Description:

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

Treatment:

Drug: LY900014