NCT01638325

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2012

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

July 9, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 11, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

June 16, 2014

Status Verified

February 1, 2013

Enrollment Period

2 months

First QC Date

July 9, 2012

Last Update Submit

June 13, 2014

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (3)

  • Pharmacokinetics: Area under the concentration curve (AUC)

    Baseline up to 8 hours post administration of study drug

  • Pharmacokinetics: Maximum concentration (Cmax)

    Baseline up to 8 hours post administration of study drug

  • Pharmacokinetics: Time of maximum concentration (Tmax)

    Baseline up to 8 hours post administration of study drug

Secondary Outcomes (3)

  • Glucodynamic response: Time to maximum infusion rate (tRmax) during euglycemic clamps of BC106 insulin lispro

    Baseline up to 30 days

  • Pharmacokinetics: Within-participant variability of time to maximum drug concentration (tmax) of BC106 insulin lispro

    Baseline up to 30 days

  • Glucodynamic within-participant variability of time to maximum glucose infusion rate (tRmax) for BC106 insulin lispro

    Baseline up to 30 days

Study Arms (2)

Insulin Lispro

ACTIVE COMPARATOR

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

BC106 Insulin Lispro

EXPERIMENTAL

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

Interventions

Insulin LisproDRUG

Administered SC

Also known as: Humalog, LY275585
Insulin Lispro
BC106 insulin lisproDRUG

Administered SC

Also known as: BioChaperone insulin lispro
BC106 Insulin Lispro

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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.

Singapore, 117597, Singapore

Location

MeSH Terms

Interventions

Insulin Lispro

Intervention Hierarchy (Ancestors)

Insulin, Short-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri, 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

    Eli Lilly and Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2012

First Posted

July 11, 2012

Study Start

July 1, 2012

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

June 16, 2014

Record last verified: 2013-02

Locations

SG(1)