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

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ClinicalTrials.gov Identifier: NCT03232983
Recruitment Status : Completed
First Posted : July 28, 2017
Results First Posted : April 30, 2020
Last Update Posted : April 30, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: LY900014 (SC) Drug: LY900014 (IV) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of Injection Site on the Relative and Absolute Bioavailability of Single Dose of LY900014 in Healthy Subjects
Actual Study Start Date : August 14, 2017
Actual Primary Completion Date : November 9, 2017
Actual Study Completion Date : November 9, 2017

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 Name: 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 Name: 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 Name: 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 Name: Ultra-Rapid Lispro




Primary Outcome Measures :
  1. Pharmacokinetics: Insulin Lispro Area Under the Concentration Versus Time Curve (AUC) Following LY900014 Administration [ 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 ]
    Pharmacokinetics(PK): Insulin lispro AUC from time zero to 10 hours post dose [AUC(0-10h)].


Secondary Outcome Measures :
  1. Total Amount of Glucose Infused (Gtot) Over Duration of the Clamp Procedure [ 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 ]
    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.



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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03232983


Locations
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Singapore
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, 117597
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: 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 Documents (Full-Text)

Documents provided by Eli Lilly and Company:
Study Protocol  [PDF] July 14, 2017
Statistical Analysis Plan  [PDF] August 4, 2017

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03232983    
Other Study ID Numbers: 16639
I8B-MC-ITRT ( Other Identifier: Eli Lilly and Company )
First Posted: July 28, 2017    Key Record Dates
Results First Posted: April 30, 2020
Last Update Posted: April 30, 2020
Last Verified: December 2017

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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
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs