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A Comparative Study of LY900014 to Insulin Lispro (Humalog) in Healthy Participants

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
LY900014
Insulin Lispro
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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 to 30 kilogram per square meter (kg/m²)
  • Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results
  • 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
  • Have previously participated or withdrawn from this study
  • Have donated blood or have blood loss of more than 500 mL within the past 3 months

Sites / Locations

  • 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.
  • 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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LY900014

Insulin Lispro (Humalog)

Arm Description

Single dose of 7 units (U), 15 U, and 30 U of LY900014 administered subcutaneously (SC) in three of six periods.

Single dose of 7 U, 15 U, and 30 U of insulin lispro administered SC in three of six periods.

Outcomes

Primary Outcome Measures

Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Versus Time Curve (AUC)
Pharmacokinetics: Insulin Lispro Area Under the Concentration Curve From Time Zero to 10 Hours Post Dose [AUC(0-10h)]

Secondary Outcome Measures

Glucodynamics: Total Amount of Glucose Infused (Gtot)
Glucodynamics: Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp

Full Information

First Posted
September 15, 2017
Last Updated
April 20, 2020
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT03286751
Brief Title
A Comparative Study of LY900014 to Insulin Lispro (Humalog) in Healthy Participants
Official Title
A Study to Evaluate the Pharmacokinetics and Glucodynamics of LY900014 and Humalog Across Different Subcutaneous Doses in Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
October 13, 2017 (Actual)
Primary Completion Date
February 6, 2018 (Actual)
Study Completion Date
February 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study compares LY900014, a drug that lowers blood sugar, with insulin lispro (Humalog). Both drugs are given 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 in comparison with insulin lispro. The study will last about 7 to 12 weeks for each participant, including screening and follow up. Screening is required within 28 days prior to entering the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LY900014
Arm Type
Experimental
Arm Description
Single dose of 7 units (U), 15 U, and 30 U of LY900014 administered subcutaneously (SC) in three of six periods.
Arm Title
Insulin Lispro (Humalog)
Arm Type
Active Comparator
Arm Description
Single dose of 7 U, 15 U, and 30 U of insulin lispro administered SC in three of six periods.
Intervention Type
Drug
Intervention Name(s)
LY900014
Other Intervention Name(s)
Ultra-Rapid Lispro
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Insulin Lispro
Other Intervention Name(s)
LY275585, Humalog
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Versus Time Curve (AUC)
Description
Pharmacokinetics: Insulin Lispro Area Under the Concentration Curve From Time Zero to 10 Hours Post Dose [AUC(0-10h)]
Time Frame
Day 1: Pre-dose, 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 70, 90, 120, 150, 180, 210, 240, 300, 360, 420, 480, 540, and 600 minutes post-dose
Secondary Outcome Measure Information:
Title
Glucodynamics: Total Amount of Glucose Infused (Gtot)
Description
Glucodynamics: Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp
Time Frame
Day 1: Every minute starting from the pre-dose and throughout the duration of the clamp until 10 hours post-dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 to 30 kilogram per square meter (kg/m²) Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results 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 Have previously participated or withdrawn from this study Have donated blood or have blood loss of more than 500 mL within the past 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Mainz
ZIP/Postal Code
55116
Country
Germany
Facility Name
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.
City
Neuss
ZIP/Postal Code
41460
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
34041713
Citation
Leohr J, Dellva MA, Carter K, LaBell E, Linnebjerg H. Ultra Rapid Lispro (URLi) Accelerates Insulin Lispro Absorption and Insulin Action vs Humalog(R) Consistently Across Study Populations: A Pooled Analysis of Pharmacokinetic and Glucodynamic Data. Clin Pharmacokinet. 2021 Nov;60(11):1423-1434. doi: 10.1007/s40262-021-01030-0. Epub 2021 May 27.
Results Reference
derived
PubMed Identifier
32900535
Citation
Leohr J, Dellva MA, LaBell E, Coutant DE, Klein O, Plum-Moerschel L, Zijlstra E, Linnebjerg H. Pharmacokinetic and Glucodynamic Responses of Ultra Rapid Lispro vs Lispro Across a Clinically Relevant Range of Subcutaneous Doses in Healthy Subjects. Clin Ther. 2020 Sep;42(9):1762-1777.e4. doi: 10.1016/j.clinthera.2020.07.005. Epub 2020 Sep 6.
Results Reference
derived

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A Comparative Study of LY900014 to Insulin Lispro (Humalog) in Healthy Participants

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