A Study of Insulin Lispro With BioChaperone Excipient in Healthy Participants

June 13, 2014 updated by: Adocia

A Study to Assess the Pharmacokinetics, Glucodynamics, Safety, and Tolerability of Single Subcutaneous Injections of Insulin Lispro With BioChaperone Excipient in Healthy Volunteers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 117597
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 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.
Drug: Insulin Lispro
Administered SC
Other Names:
  • Humalog
  • LY275585
EXPERIMENTAL: 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.
Drug: BC106 insulin lispro
Administered SC
Other Names:
  • BioChaperone insulin lispro

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics: Area under the concentration curve (AUC)
Time Frame: Baseline up to 8 hours post administration of study drug
Baseline up to 8 hours post administration of study drug
Pharmacokinetics: Maximum concentration (Cmax)
Time Frame: Baseline up to 8 hours post administration of study drug
Baseline up to 8 hours post administration of study drug
Pharmacokinetics: Time of maximum concentration (Tmax)
Time Frame: Baseline up to 8 hours post administration of study drug
Baseline up to 8 hours post administration of study drug

Secondary Outcome Measures

Outcome Measure
Time Frame
Glucodynamic response: Time to maximum infusion rate (tRmax) during euglycemic clamps of BC106 insulin lispro
Time Frame: Baseline up to 30 days
Baseline up to 30 days
Pharmacokinetics: Within-participant variability of time to maximum drug concentration (tmax) of BC106 insulin lispro
Time Frame: Baseline up to 30 days
Baseline up to 30 days
Glucodynamic within-participant variability of time to maximum glucose infusion rate (tRmax) for BC106 insulin lispro
Time Frame: Baseline up to 30 days
Baseline up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adocia

Collaborators

Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (ACTUAL)

September 1, 2012

Study Completion (ACTUAL)

September 1, 2012

Study Registration Dates

First Submitted

July 9, 2012

First Submitted That Met QC Criteria

July 9, 2012

First Posted (ESTIMATE)

July 11, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

June 16, 2014

Last Update Submitted That Met QC Criteria

June 13, 2014

Last Verified

February 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14771
  • H9D-MC-ITAG (OTHER: Eli Lilly and Company)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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