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

NCT03286751 | Completed Phase 1 Results FDA Drug

• 3 other identifiers: 168982017-001859-32I8B-MC-ITSH
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• 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 \[AUC(0-10h)\]

  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 Outcomes (1)

• Glucodynamics: Total Amount of Glucose Infused (Gtot)

  Day 1: Every minute starting from the pre-dose and throughout the duration of the clamp until 10 hours post-dose

Study Arms (2)

LY900014

EXPERIMENTAL

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

Drug: LY900014

Insulin Lispro (Humalog)

ACTIVE COMPARATOR

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

Drug: Insulin Lispro

Interventions

LY900014 DRUG

Administered SC

Also known as: Ultra-Rapid Lispro

LY900014

Insulin Lispro DRUG

Administered SC

Also known as: LY275585, Humalog

Insulin Lispro (Humalog)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (2)

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.

Mainz, 55116, Germany

Location

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.

Neuss, 41460, Germany

Location

Related Publications (2)

• 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.

  PMID: 34041713 DERIVED

• 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.

  PMID: 32900535 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Lispro

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

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: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2017
• First Posted: September 18, 2017
• Study Start: October 13, 2017
• Primary Completion: February 6, 2018
• Study Completion: February 6, 2018
• Last Updated: May 1, 2020
• Results First Posted: May 1, 2020

Record last verified: 2018-02

Locations

DE (2)