A Study of LY2605541 and Insulin Lispro Mixture in Healthy Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2013-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

LY2605541

Intervention Type DRUG

Administered subcutaneous (SQ)

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.

Group Type ACTIVE_COMPARATOR

Insulin Lispro

Intervention Type DRUG

Administered SQ

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.

Group Type EXPERIMENTAL

LY2605541

Intervention Type DRUG

Administered subcutaneous (SQ)

Insulin Lispro

Intervention Type DRUG

Administered SQ

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.

Group Type EXPERIMENTAL

LY2605541

Intervention Type DRUG

Administered subcutaneous (SQ)

Insulin Lispro

Intervention Type DRUG

Administered SQ

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.

Group Type ACTIVE_COMPARATOR

Insulin Lispro

Intervention Type DRUG

Administered SQ

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.

Group Type EXPERIMENTAL

LY2605541

Intervention Type DRUG

Administered subcutaneous (SQ)

Insulin Lispro

Intervention Type DRUG

Administered SQ

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.

Group Type EXPERIMENTAL

LY2605541

Intervention Type DRUG

Administered subcutaneous (SQ)

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.

Group Type EXPERIMENTAL

LY2605541

Intervention Type DRUG

Administered subcutaneous (SQ)

Interventions

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LY2605541

Administered subcutaneous (SQ)

Intervention Type DRUG

Insulin Lispro

Administered SQ

Intervention Type DRUG

Other Intervention Names

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Humalog

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes