A Study of LY2605541 and Insulin Lispro Mixture in Healthy Participants

A Phase 1 Study to Evaluate the Pharmacokinetics of LY2605541 Injection and Insulin Lispro Injection Administered as Mixture or as Individual Components in Healthy Subjects

The main purpose of this study is to evaluate how the body absorbs and removes LY2605541, insulin lispro, and a mixture of both from the blood. The study has two parts. Participants may enroll in only one part. Each part has four treatment periods in a fixed order. The study will last approximately 8 weeks, not including screening. Screening is required within 28 days prior to the start of the study.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: LY2605541; Drug: Insulin Lispro

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 117597
    • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Are not of child-bearing potential
• Have a body mass index (BMI) between 18 and 29.9 kilograms per meter squared (kg/m^2), inclusive
• Are nonsmokers or have not smoked for at least 2 months prior to entering the study

Exclusion Criteria:

• Have known allergies to insulin or its excipients, or related drugs, or history of relevant allergic reactions of any origin
• Have a history of first-degree relatives known to have diabetes mellitus
• Have used systemic glucocorticoids within 3 months prior to entry into the study
• Have donated blood or had a blood loss of 450 milliliter (mL) within 1 month prior to study enrollment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LY2605541-Part A; 1.42 units per kilogram (U/kg) of LY2605541 given once daily (QD) for 1 day, subcutaneously (SQ) in 1 of 4 treatment periods.	Drug: LY2605541; Administered subcutaneous (SQ)
Active Comparator: Insulin Lispro-Part A; Single dose 0.36 U/kg of insulin lispro given QD for 1 day, SQ in 1 of 4 treatment periods.	Drug: Insulin Lispro; Administered SQ; Other Names: Humalog
Experimental: LY2605541/Lispro Mix 1-Part A; Single dose 0.54 U/kg of LY2605541 and 0.36 U/kg insulin lispro mixture given QD for 1 day, SQ in 1 of 4 treatment periods.	Drug: LY2605541; Administered subcutaneous (SQ); Drug: Insulin Lispro; Administered SQ; Other Names: Humalog
Experimental: LY2605541/Lispro Mix 2-Part A; Single dose 1.42 U/kg of LY2605541 and 0.36 insulin lispro mixture given QD for 1 day, SQ in 1 of 4 treatment periods.	Drug: LY2605541; Administered subcutaneous (SQ); Drug: Insulin Lispro; Administered SQ; Other Names: Humalog
Active Comparator: Insulin Lispro-Part B; 0.18 U/kg insulin lispro given twice daily (BID) for 1 day, SQ in 1 of 4 treatment periods. Part B is contingent on data from Part A.	Drug: Insulin Lispro; Administered SQ; Other Names: Humalog
Experimental: LY2605541/Lispro Mix-Part B; 0.71 U/kg LY2605541 and 0.18 U/kg insulin lispro mixture given BID for 1 day, SQ in 1 of 4 treatment periods. Part B is contingent on data from Part A.	Drug: LY2605541; Administered subcutaneous (SQ); Drug: Insulin Lispro; Administered SQ; Other Names: Humalog
Experimental: LY2605541 QD-Part B; 0.54 U/kg of LY2605541 given QD for 1 day, SQ in 1 of 4 treatment periods. Part B is contingent on data from Part A.	Drug: LY2605541; Administered subcutaneous (SQ)
Experimental: LY2605541 BID-Part B; 0.71 U/kg of LY2605541 given BID for 1 day SQ in 1 of 4 treatment periods. Part B is contingent on data from Part A.	Drug: LY2605541; Administered subcutaneous (SQ)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics (PK): Time to Reach Peak Concentration (tmax) of LY2605541 and Insulin Lispro	Pre-dose up to 216 hours post-dose
Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY2605541 and Insulin Lispro	Pre-dose up to 216 hours post-dose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC0-∞) of LY2605541 and Insulin Lispro	Pre-dose up to 216 hours post-dose

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximum Glucose Infusion Rate (Rmax)	Predose up to 32 hours post clamp procedure in all treatment periods
Total Glucose Infused Over Clamp Duration (Gtot)	Predose up to 32 hours post clamp procedure in all treatment periods

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: June 4, 2013
• First Submitted That Met QC Criteria: June 4, 2013
• First Posted (Estimate): June 6, 2013

Study Record Updates

• Last Update Posted (Estimate): October 21, 2014
• Last Update Submitted That Met QC Criteria: October 20, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Insulin Lispro
• Other Study ID Numbers: 14833; I6O-FW-BHBA (Other Identifier: Eli Lilly and Company)