A Study of a New LY900014 Formulation in Healthy Participants

Pharmacokinetics, Glucodynamics, Safety, and Tolerability of a Novel LY900014 Formulation

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 for about 8 to 9 weeks for each participant, including screening and follow up. Screening is required within 28 days prior to entering the study.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore
    • 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.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Overtly healthy male or a female (not pregnant and agreeable to take birth control measures until one month after study completion)
• Have a body mass index (BMI) of 18.5 to 30 kilogram per square meter (kg/m^2), 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• Have previously participated or withdrawn from this study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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LY900014 7.5 Units (U); Single dose of 7.5 U LY900014 administered subcutaneously (SC) in one to two of five periods.	Drug: LY900014; Administered SC; Other Names: Ultra-Rapid Lispro
Active Comparator: Insulin Lispro; Reference formulation. Single dose of Insulin Lispro administered SC in one to two of five periods.	Drug: Insulin Lispro (Humalog); Administered SC; Other Names: Humalog; LY275585
Experimental: LY900014 15 U; Single dose of 15 U LY900014 administered subcutaneously (SC) in one to two of five periods.	Drug: LY900014; Administered SC; Other Names: Ultra-Rapid Lispro
Experimental: LY900014 30 U; Single dose of 30 U LY900014 administered subcutaneously (SC) in one to two of five periods.	Drug: LY900014; Administered SC; Other Names: Ultra-Rapid Lispro

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics (PK) : Insulin Lispro Area Under the Concentration Curve Zero to Infinity (AUC[0-∞]) )	5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, and 420 minutes per period.

Secondary Outcome Measures

Outcome Measure	Time Frame
Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp	Every 10 minutes for 30 minutes Predose, Postdose: every 2.5 minutes for 30 minutes, then every 5 minutes until 120 minutes, then every 10 minutes until 300 minutes, then every 20 minutes until 480 minutes

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: August 14, 2015
• First Submitted That Met QC Criteria: August 14, 2015
• First Posted (Estimate): August 17, 2015

Study Record Updates

• Last Update Posted (Actual): May 19, 2020
• Last Update Submitted That Met QC Criteria: May 7, 2020
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Insulin Lispro
• Other Study ID Numbers: 15989; I8B-FW-ITRE (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

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