A Study of LY900014 Formulation in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LY900014; Drug: Insulin Lispro

• Registration Number: NCT02942654
• Lead Sponsor: Eli Lilly and Company

Brief Summary

This study evaluates a new formulation of LY900014, a drug that lowers blood sugar. It is administered by injection under the skin of the abdomen. The study will be conducted in healthy people to investigate how quickly and how much LY900014 is absorbed and the effect of different doses of LY900014 on blood sugar levels. Side effects and tolerability will be documented. The study will last about 6 to 7 weeks for each participant, including screening and follow up. Screening is required within 28 days prior to entering the study.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-21
• Study First Submitted QC: 2016-10-21
• Study First Posted: 2016-10-24
• Study Start: 2016-11
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-01
• Results First Submitted: 2020-04-15
• Results First Submitted QC: 2020-04-15
• Last Update Submitted: 2020-04-15
• Results First Posted: 2020-04-27
• Last Update Posted: 2020-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Overtly healthy male or a female (not pregnant and agreeable to take birth control measures until study completion)
• Have a body mass index (BMI) of 18 to 30 kilogram per square meter (kg/m²), inclusive, at screening
• Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study
• Are nonsmokers, have not smoked for at least 2 months prior to entering the study, and agree not to smoke (cigars, cigarettes, or pipes) or use smokeless tobacco for the duration of the study

Exclusion Criteria

• Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
• Have previously participated or withdrawn from this study
• Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
• Had blood loss of more than 450 milliliters (mL) within the last month

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
LY900014	LY900014	Test formulation. 15-U dose of LY900014 administered subcutaneously (SC) in one of two periods.
Insulin Lispro	Insulin Lispro	Reference formulation. 15-U dose of Insulin Lispro administered SC in one of two periods.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 8 Hours (AUC[0-8 Hours])	Predose (0), 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 210, 240, 300, 330, 360, 420, and 480 minutes, post dose	Area Under the Concentration Versus Time Curve (AUC) was measured from time zero to 8 hours (AUC\[0-8 Hours\]).

Secondary Outcome Measures

Name	Time	Method
Glucodynamics (GD): Total Amount of Glucose Infused (Gtot)	2.5 minutes for the first 30 minutes, then every 5 minutes until 120 minutes postdose, and then every 10 minutes until 480 minutes postdose	Gtot is used to measure the study drug action over time as measured by the euglycaemic clamp procedure. During the euglycaemic clamp procedure, blood glucose concentrations are held constant after the administration of LY900014 or Insulin Lispro by adjusting the exogenous glucose infusion rate. Data presented were adjusted by the body weight.

Trial Locations

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.; 🇸🇬 Singapore, Singapore