A Study of Insulin Peglispro in Healthy Male Japanese Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Insulin Peglispro

Study type: Interventional

Funder types: Industry

Identifiers

NCT01995526

I2R-JE-BIDK (Other Identifier)

14682

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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]).

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

Insulin Peglispro

Experimental group

Description:

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

Treatment:

Drug: Insulin Peglispro