A Study of a New LY900014 Formulation in Healthy Participants

NCT02525744 | Completed Phase 1 Results

• 2 other identifiers: 15989I8B-FW-ITRE
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (4)

LY900014 7.5 Units (U)

EXPERIMENTAL

Single dose of 7.5 U LY900014 administered subcutaneously (SC) in one to two of five periods.

Drug: LY900014

Insulin Lispro

ACTIVE COMPARATOR

Reference formulation. Single dose of Insulin Lispro administered SC in one to two of five periods.

Drug: Insulin Lispro (Humalog)

LY900014 15 U

EXPERIMENTAL

Single dose of 15 U LY900014 administered subcutaneously (SC) in one to two of five periods.

Drug: LY900014

LY900014 30 U

EXPERIMENTAL

Single dose of 30 U LY900014 administered subcutaneously (SC) in one to two of five periods.

Drug: LY900014

Interventions

LY900014 DRUG

Administered SC

Also known as: Ultra-Rapid Lispro

LY900014 15 U; LY900014 30 U; LY900014 7.5 Units (U)

Insulin Lispro (Humalog) DRUG

Administered SC

Also known as: LY275585, Humalog

Insulin Lispro

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (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

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@lilly.com

800-545-5979

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: Yes
• Restrictive Agreement: No

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 14, 2015
• First Posted: August 17, 2015
• Study Start: August 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: May 19, 2020
• Results First Posted: May 19, 2020

Record last verified: 2015-10

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)