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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01871493

Enrollment

Registered

2013-06-06

Start date

2013-06-30

Completion date

2013-09-30

Last updated

2014-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Brief summary

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.

Interventions

DRUGLY2605541

Administered subcutaneous (SQ)

DRUGInsulin Lispro

Administered SQ

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

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

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026