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

• 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: Eli Lilly and Company
• Information provided by (Responsible Party): Eli Lilly and Company

Tracking Information

• First Submitted Date: July 26, 2017
• First Posted Date: July 28, 2017
• Results First Submitted Date: April 20, 2020
• Results First Posted Date: April 30, 2020
• Last Update Posted Date: April 30, 2020
• Actual Study Start Date: August 14, 2017
• Actual Primary Completion Date: November 9, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 20, 2020)

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)].

Original Primary Outcome Measures (submitted: July 26, 2017)

Pharmacokinetics: Insulin Lispro Area under the concentration versus time curve (AUC) following LY900014 administration [ Time Frame: Predose through 10 hours postdose on day 1 in each study arm ]

Pharmacokinetics: Insulin Lispro Area Under the Concentration Curve From Time Zero to 10 hours post dose [AUC(0-10h)]

Current Secondary Outcome Measures (submitted: April 20, 2020)

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.

Original Secondary Outcome Measures (submitted: July 26, 2017)

Total Amount of Glucose Infused (Gtot) [ Time Frame: Predose through 10 hours postdose on day 1 in each study arm ]

Glucodynamics: Total Amount of Glucose Infused (Gtot)

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Basic Science
• Condition: Diabetes Mellitus, Type 2

Intervention

• Drug: LY900014 (SC)
  Administered SC
  Other Name: Ultra-Rapid Lispro
• Drug: LY900014 (IV)
  Administered IV
  Other Name: Ultra-Rapid Lispro

Study Arms

• Experimental: LY900014 (SC Abdomen)
  Single dose of 15-U of LY900014 administered subcutaneously (SC) into the abdomen in one period
  Intervention: Drug: LY900014 (SC)
• Experimental: LY900014 (SC Thigh)
  Single dose of 15-U of LY900014 administered SC into the thigh in one period
  Intervention: Drug: LY900014 (SC)
• Experimental: LY900014 (SC Arm)
  Single dose of 15-U of LY900014 administered SC into the arm (deltoid) in one period
  Intervention: Drug: LY900014 (SC)
• Active Comparator: LY900014 (IV)
  Single dose of 15-U of LY900014 administered intravenously (IV) in one period
  Intervention: Drug: LY900014 (IV)

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 26, 2017): 28
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: November 9, 2017
• Actual Primary Completion Date: November 9, 2017 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Singapore

Administrative Information

• NCT Number: NCT03232983
• Other Study ID Numbers: 16639; I8B-MC-ITRT ( Other Identifier: Eli Lilly and Company )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Eli Lilly and Company
• Original Responsible Party: Same as current
• Current Study Sponsor: Eli Lilly and Company
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• 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

• PRS Account: Eli Lilly and Company
• Verification Date: December 2017