Healthy ParticipantsPhase 1NCT01638325
A Study of Insulin Lispro With BioChaperone Excipient in Healthy Participants
A Phase 1 study testing Insulin Lispro and BC106 insulin lispro in people with Healthy Participants, run by Adocia at 1 site in Singapore.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Insulin Lispro and BC106 insulin lispro
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteSingapore
- Study dates
- Jul 2012to Sep 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Singapore1 site
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
About this study
Official title: 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.
- Conditions
- Healthy Participants
- Being tested
- Insulin Lispro, BC106 insulin lispro
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin LisproDrug
Also called Humalog, LY275585
Administered SC
BC106 insulin lisproDrug
Also called BioChaperone insulin lispro
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: BC106 insulin lispro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics: Area under the concentration curve (AUC)
Measured: Baseline up to 8 hours post administration of study drug
Pharmacokinetics: Maximum concentration (Cmax)
Measured: Baseline up to 8 hours post administration of study drug
Pharmacokinetics: Time of maximum concentration (Tmax)
Measured: 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
Measured: Baseline up to 30 days
Pharmacokinetics: Within-participant variability of time to maximum drug concentration (tmax) of BC106 insulin lispro
Measured: Baseline up to 30 days
Glucodynamic within-participant variability of time to maximum glucose infusion rate (tRmax) for BC106 insulin lispro
Measured: Baseline up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adocia
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01638325
- Sponsor's protocol ID
- 14771
- Other IDs
- H9D-MC-ITAG
- Status last verified
- Feb 2013
- First submitted
- 9 Jul 2012
- Last updated
- 16 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Pharmacokinetics, Glucodynamics, Safety, and Tolerability of Single Subcutaneous Injections of Insulin Lispro With BioChaperone Excipient in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01638325
- Acronym / sponsor ID
- 14771
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- AdociaIndustry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Study start
- Jul 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 11 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin Lispro | Active comparator | Drug: Insulin Lispro15 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. |
| BC106 Insulin Lispro | Experimental | Drug: BC106 insulin lispro15 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. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin LisproAlso: Humalog, LY275585Administered SC | Drug | Insulin Lispro |
| BC106 insulin lisproAlso: BioChaperone insulin lisproAdministered SC | Drug | BC106 Insulin Lispro |
Primary outcome
Pharmacokinetics: Area under the concentration curve (AUC)
Time frame: 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
Pharmacokinetics: Time of maximum concentration (Tmax)
Time frame: Baseline up to 8 hours post administration of study drug
3 secondary outcomes
Glucodynamic response: Time to maximum infusion rate (tRmax) during euglycemic clamps of BC106 insulin lispro
Time frame: 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
Glucodynamic within-participant variability of time to maximum glucose infusion rate (tRmax) for BC106 insulin lispro
Time frame: Baseline up to 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Insulin Lispro and BC106 insulin lispro in people with Healthy Participants, run by Adocia at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics: Area under the concentration curve (AUC) (time frame: Baseline up to 8 hours post administration of study drug). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2014.