A Study of LY900014 in Healthy Chinese Participants

NCT04049123 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 16644I8B-MC-ITRY
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot)

  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

Study Arms (2)

Insulin Lispro (Humalog)

ACTIVE COMPARATOR

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

Drug: Insulin Lispro

LY900014

EXPERIMENTAL

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

Drug: LY900014

Interventions

LY900014 DRUG

Administered SC

Also known as: Ultra-Rapid Lispro

LY900014

Insulin Lispro DRUG

Administered SC

Also known as: LY275585, Humalog

Insulin Lispro (Humalog)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

West China Hospital Sichuan University

Chengdu, Cn-51, 610041, China

Location

MeSH Terms

Interventions

Insulin Lispro

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@llilly.com

800-595-5979

Study Officials

• 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 DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2019
• First Posted: August 7, 2019
• Study Start: November 18, 2019
• Primary Completion: October 23, 2020
• Study Completion: October 23, 2020
• Last Updated: November 16, 2021
• Results First Posted: November 16, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)