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

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: LY900014; Drug: Insulin Lispro

• Registration Number: NCT03286751
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-15
• Study First Submitted QC: 2017-09-15
• Study First Posted: 2017-09-18
• Study Start: 2017-10-13
• Status Verified: 2018-02
• Primary Completion: 2018-02-06
• Study Completion: 2018-02-06
• Results First Submitted: 2020-04-20
• Results First Submitted QC: 2020-04-20
• Last Update Submitted: 2020-04-20
• Results First Posted: 2020-05-01
• Last Update Posted: 2020-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• 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

Exclusion Criteria

• 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• Have previously participated or withdrawn from this study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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
LY900014	LY900014	Single dose of 7 units (U), 15 U, and 30 U of LY900014 administered subcutaneously (SC) in three of six periods.
Insulin Lispro (Humalog)	Insulin Lispro	Single dose of 7 U, 15 U, and 30 U of insulin lispro administered SC in three of six periods.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Versus Time Curve (AUC)	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	Pharmacokinetics: Insulin Lispro Area Under the Concentration Curve From Time Zero to 10 Hours Post Dose \[AUC(0-10h)\]

Secondary Outcome Measures

Name	Time	Method
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	Glucodynamics: Total Amount of Glucose Infused (Gtot) Over the Duration of Clamp

Trial Locations

Locations (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.; 🇩🇪 Neuss, Germany