A Study of LY900014 Formulation at Different Injection Sites in Healthy Participants

Effect of Injection Site on the Relative and Absolute Bioavailability of Single Dose of LY900014 in Healthy Subjects

This study evaluates a new formulation of insulin lispro, LY900014, a drug that lowers blood sugar. It is administered by injection into the vein and under the skin of the abdomen, thigh and arm.

The study will be conducted in healthy people to investigate the effect of different injection sites on the amount of insulin lispro in the bloodstream.

Side effects and tolerability will be documented. The study will last for about 10 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: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: LY900014 (SC); Drug: LY900014 (IV)

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 1

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 117597
    • 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 study completion)
• Have a body mass index (BMI) of 18 to 30 kilogram per square meter (kg/m²)
• 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 6 months prior to entering 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• Have previously participated or withdrawn from this study
• Had blood loss of more than 450 milliliters (mL) within the last 3 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: LY900014 (SC Abdomen); Single dose of 15-U of LY900014 administered subcutaneously (SC) into the abdomen in one period	Drug: LY900014 (SC); Administered SC; Other Names: Ultra-Rapid Lispro
EXPERIMENTAL: LY900014 (SC Thigh); Single dose of 15-U of LY900014 administered SC into the thigh in one period	Drug: LY900014 (SC); Administered SC; Other Names: Ultra-Rapid Lispro
EXPERIMENTAL: LY900014 (SC Arm); Single dose of 15-U of LY900014 administered SC into the arm (deltoid) in one period	Drug: LY900014 (SC); Administered SC; Other Names: Ultra-Rapid Lispro
ACTIVE_COMPARATOR: LY900014 (IV); Single dose of 15-U of LY900014 administered intravenously (IV) in one period	Drug: LY900014 (IV); Administered IV; Other Names: Ultra-Rapid Lispro

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics: Insulin Lispro Area Under the Concentration Versus Time Curve (AUC) Following LY900014 Administration	Pharmacokinetics(PK): Insulin lispro AUC from time zero to 10 hours post dose [AUC(0-10h)].	Day 1: Pre-dose, 2.5, 5, 10, 15, 20, 25, 30, 40, 60, 70, 90, 120, 150, 180, 210, 240, 300, 360, 420, 480, 540, and 600 minutes post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Amount of Glucose Infused (Gtot) Over Duration of the Clamp Procedure	Glucodynamics: Gtot is the total glucose infusion over the clamp duration (10 hours) and is used to measure the study drug action over time as measured by the euglycemic clamp procedure. During the euglycemic clamp procedure, blood glucose concentrations are held constant after the administration of LY900014 by adjusting the exogenous glucose infusion rate.	Every 10 minutes for 30 minutes predose, every 2.5 minutes for 30 minutes, then every 5 minutes for 120 minutes, then every 10 minutes for 120 to 480 minutes and every 10 minutes for 480 to 600 minutes post-dose

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Publications and helpful links

General Publications

• Leohr JK, Dellva MA, LaBell E, Coutant DE, Linnebjerg H. Evaluation of the Pharmacokinetic Profile of Ultra Rapid Lispro Administered Subcutaneously at Different Injection Sites. Clin Ther. 2022 Jun;44(6):836-847. doi: 10.1016/j.clinthera.2022.04.001. Epub 2022 May 13.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 14, 2017
• Primary Completion (ACTUAL): November 9, 2017
• Study Completion (ACTUAL): November 9, 2017

Study Registration Dates

• First Submitted: July 26, 2017
• First Submitted That Met QC Criteria: July 26, 2017
• First Posted (ACTUAL): July 28, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 30, 2020
• Last Update Submitted That Met QC Criteria: April 20, 2020
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin Lispro
• Other Study ID Numbers: 16639; I8B-MC-ITRT (OTHER: Eli Lilly and Company)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes