A Study of Insulin Peglispro in Healthy Male Japanese Participants

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2014-01-31

Brief Summary

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The main purpose of this study is to evaluate how the body processes the study drug known as insulin peglispro and how the study drug affects blood sugar in healthy male Japanese participants. This study will also evaluate safety of the study drug. The study will last up to 46 days for each participant, not including screening.

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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

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Insulin Peglispro

Single subcutaneous dose of 1.3 Units per kilogram (U/kg) insulin peglispro on Day 1.

Group Type EXPERIMENTAL

Insulin Peglispro

Intervention Type DRUG

Interventions

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Insulin Peglispro

Intervention Type DRUG

Other Intervention Names

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LY2605541

Eligibility Criteria

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Inclusion Criteria

* Participants are overtly healthy male Japanese.
* Participants have Body Mass Index (BMI) between 18.5 and 25.0 kilograms per square meter (kg/m\^2), inclusive.

Exclusion Criteria

* Participants have known allergies to insulin peglispro or related compounds.
* Participants have a fasting venous blood glucose \>108 milligrams per deciliter (mg/dL) (\>6 millimoles per liter \[mmol/L\]).

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes