A Study of Insulin Lispro With BioChaperone Excipient 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

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2012-09-30

Brief Summary

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BC106 is a molecule that when injected with insulin lispro may change the speed of absorption of insulin lispro. The purpose of this study will be to evaluate the safety of BC106 insulin lispro and any side effects that might be associated with it, blood levels of insulin lispro after injection under the skin and how BC106 insulin lispro affects blood sugar after injection under the skin. There is a minimum 7 day washout between single doses.

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Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Insulin Lispro

15 international units (IU) insulin lispro administered once subcutaneously (SC) during 1 of 3 dosing periods. There is a minimum 7 day washout between dosing periods.

Group Type ACTIVE_COMPARATOR

Insulin Lispro

Intervention Type DRUG

Administered SC

BC106 Insulin Lispro

15 up to 30 IU BC106 insulin lispro administered once SC during 2 of 3 dosing periods. There is a minimum 7 day washout between dosing periods.

Group Type EXPERIMENTAL

BC106 insulin lispro

Intervention Type DRUG

Administered SC

Interventions

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Insulin Lispro

Administered SC

Intervention Type DRUG

BC106 insulin lispro

Administered SC

Intervention Type DRUG

Other Intervention Names

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Humalog LY275585 BioChaperone insulin lispro

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 square meter (kg/m\^2), inclusive
* Are nonsmokers or have not smoked for at least 6 months prior to entering the study
* Have a fasting plasma glucose less than 6.0 millimoles per liter (mmol/L) at screening

Exclusion Criteria

* Have known allergies to insulin or its excipients, or related drugs, or history of relevant allergic reactions of any origin including allergies to dextrans
* 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 or had a blood loss of 450 milliliters (mL) 3 months prior to study enrollment

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes