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

NCT03232983 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 16639I8B-MC-ITRT
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• 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 \[AUC(0-10h)\].

  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 Outcomes (1)

• Total Amount of Glucose Infused (Gtot) Over Duration of the Clamp Procedure

  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

Study Arms (4)

LY900014 (SC Abdomen)

EXPERIMENTAL

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

Drug: LY900014 (SC)

LY900014 (SC Thigh)

EXPERIMENTAL

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

Drug: LY900014 (SC)

LY900014 (SC Arm)

EXPERIMENTAL

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

Drug: LY900014 (SC)

LY900014 (IV)

ACTIVE COMPARATOR

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

Drug: LY900014 (IV)

Interventions

LY900014 (SC) DRUG

Administered SC

Also known as: Ultra-Rapid Lispro

LY900014 (SC Abdomen); LY900014 (SC Arm); LY900014 (SC Thigh)

LY900014 (IV) DRUG

Administered IV

Also known as: Ultra-Rapid Lispro

LY900014 (IV)

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

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, Singapore

Location

Related Publications (1)

• 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.

  PMID: 35577602 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

Clinicaltrials.gov@lilly.com

800-545-5979

Study Officials

• 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 DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2017
• First Posted: July 28, 2017
• Study Start: August 14, 2017
• Primary Completion: November 9, 2017
• Study Completion: November 9, 2017
• Last Updated: April 30, 2020
• Results First Posted: April 30, 2020

Record last verified: 2017-12

Locations

SG (1)