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OpenTrials
Completed

NCT Number: NCT02636361

A Study of Various Formulations of LY900014 in Healthy Participants

This study will evaluate how quickly the body absorbs, breaks down, and gets rid of the different formulations of LY900014. This study will determine how the different formulations, when injected under the skin, will affect the blood sugar levels in the body, and how safe it is.

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Key information

Conditions

Healthy

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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, 117597

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Overtly healthy male or a female (not pregnant and agreeable to take birth control measures until one month after study completion)
  • Must have a body mass index (BMI) of 18.0 to 30 kilogram per square meter (kg/m²) (inclusive) at the time of study screening
  • Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study
  • Are non-smokers or 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
  • Have veins suitable for easy blood collection and glucose solution infusion

Exclusion criteria

  • Have known allergies to insulin lispro or compounds related to these drugs, or any components of the study drug
  • Show signs of having an infection or infectious disease at the time of study entry

Treatment and study plan

LY900014

Drug

Administered subcutaneously (SC)

Other names: Ultra-Rapid Lispro

Insulin Lispro (Humalog)

Drug

Administered SC

Other names: Humalog, LY275585

Primary outcomes

  1. Pharmacokinetics (PK): Area Under The Concentration Curve (AUC 0-30mins) of Insulin Lispro

    Time frame: Predose,5,10,15,20,25,30,35,40,45,50,55,60,70,90,120,150,180,240,300, 360 and 420 minutes postdose

Secondary outcomes

  1. Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp

    Time frame: Predose, every 2.5 minutes for 30 minutes, then every 5 min until 120 minutes, then every 10 minutes until 300 minutes, then every 20 minutes until 480 minutes.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Pharmacokinetics, Glucodynamics, Safety, and Tolerability of Multiple LY900014 Formulations

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 21, 2015
Registry last updated
May 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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