search
Back to results

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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 1
Locations
Singapore
Study Type
Interventional
Intervention
LY900014 (SC)
LY900014 (IV)
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

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

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  • Have previously participated or withdrawn from this study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

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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

LY900014 (SC Abdomen)

LY900014 (SC Thigh)

LY900014 (SC Arm)

LY900014 (IV)

Arm Description

Single dose of 15-U of LY900014 administered subcutaneously (SC) into the abdomen in one period

Single dose of 15-U of LY900014 administered SC into the thigh in one period

Single dose of 15-U of LY900014 administered SC into the arm (deltoid) in one period

Single dose of 15-U of LY900014 administered intravenously (IV) in one period

Outcomes

Primary Outcome Measures

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)].

Secondary Outcome Measures

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.

Full Information

First Posted
July 26, 2017
Last Updated
April 20, 2020
Sponsor
Eli Lilly and Company
search

1. Study Identification

Unique Protocol Identification Number
NCT03232983
Brief Title
A Study of LY900014 Formulation at Different Injection Sites in Healthy Participants
Official Title
Effect of Injection Site on the Relative and Absolute Bioavailability of Single Dose of LY900014 in Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
August 14, 2017 (Actual)
Primary Completion Date
November 9, 2017 (Actual)
Study Completion Date
November 9, 2017 (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 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.

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
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LY900014 (SC Abdomen)
Arm Type
Experimental
Arm Description
Single dose of 15-U of LY900014 administered subcutaneously (SC) into the abdomen in one period
Arm Title
LY900014 (SC Thigh)
Arm Type
Experimental
Arm Description
Single dose of 15-U of LY900014 administered SC into the thigh in one period
Arm Title
LY900014 (SC Arm)
Arm Type
Experimental
Arm Description
Single dose of 15-U of LY900014 administered SC into the arm (deltoid) in one period
Arm Title
LY900014 (IV)
Arm Type
Active Comparator
Arm Description
Single dose of 15-U of LY900014 administered intravenously (IV) in one period
Intervention Type
Drug
Intervention Name(s)
LY900014 (SC)
Other Intervention Name(s)
Ultra-Rapid Lispro
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
LY900014 (IV)
Other Intervention Name(s)
Ultra-Rapid Lispro
Intervention Description
Administered IV
Primary Outcome Measure Information:
Title
Pharmacokinetics: Insulin Lispro Area Under the Concentration Versus Time Curve (AUC) Following LY900014 Administration
Description
Pharmacokinetics(PK): Insulin lispro AUC from time zero to 10 hours post dose [AUC(0-10h)].
Time Frame
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 Measure Information:
Title
Total Amount of Glucose Infused (Gtot) Over Duration of the Clamp Procedure
Description
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.
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
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
Singapore
ZIP/Postal Code
117597
Country
Singapore

12. IPD Sharing Statement

Citations:
PubMed Identifier
35577602
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs