Diabetes Mellitus Type 1Phase 1NCT02029924
A Double-blinded, Randomised, Two -Period Crossover Euglycemic Clamp Trial Investigating the Pharmacokinetics, Glucodynamics and Safety of BioChaperone Insulin Lispro and Insulin Lispro (Humalog®) in Subjects With Type 1 Diabetes
A Phase 1 study testing BioChaperone insulin lispro and Humalog® in people with Diabetes Mellitus Type 1, run by Adocia at 1 site in Germany.
Trial summary
The addition of Biochaperone to insulin lispro may accelerate the onset and shorten the duration of action of insulin lispro due to a facilitation of the absorption of the insulin after subcutaneous injection. Read more about this study
- Who is it for?
- Ages 18 to 64 years, men only
- Conditions the study is for
- Diabetes Mellitus Type 1
- What is being tested?
- BioChaperone insulin lispro and Humalog®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2013to Aug 2014
- 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 18 to 64 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Type 1 diabetes mellitus for at least 12 months.
- Treated with multiple daily insulin injections or insulin pump for at least 12 months.
- Body Mass Index (BMI): 18.0-28.0 Kg/m².
Who cannot join
- Type 2 diabetes mellitus.
- Receipt of any investigational product within 3 months prior to first dosing.
- Clinically significant abnormalities as judged by the investigator.
- Any systemic treatment with drugs known to interfere with glucose metabolism.
- History of alcoholism, or drug/chemical abuse as per Investigator's judgement.
- Use of tobacco or nicotine-contained product within 5 years prior to screening.
- Blood or plasma donation in the past month or more than 500 mL within 3 months prior to screening.
Trial locations and contacts
1 site in 1 country.
About this study
The addition of Biochaperone to insulin lispro may accelerate the onset and shorten the duration of action of insulin lispro due to a facilitation of the absorption of the insulin after subcutaneous injection.
The aim of the trial is to assess the efficacy and safety of BioChaperone insulin lispro in subjects with Type 1 diabetes under a dose of 0.2 U/Kg.
This trial is a single-center, randomised, double-blinded, two-treatment, two-period cross-over, 6-hour euglycaemic glucose clamp trial in subjects with Type 1 diabetes mellitus. Each subject will be randomly allocated to a single dose of BioChaperone insulin lispro 0.2 U/Kg and a single dose of Humalog® 0.2 U/Kg on 2 separate dosing visits.
- Conditions
- Diabetes Mellitus Type 1
- Being tested
- BioChaperone insulin lispro, Humalog®
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioChaperone insulin lisproDrug
Single dose of 0.2 U/Kg body weight injected subcutaneously (under the skin)
Humalog®Drug
Single dose of 0.2 /Kg body weight injected subcutaneously (under the skin)
| Study group | Role | What they receive |
|---|---|---|
| BioChaperone insulin lispro | Experimental | BioChaperone insulin lispro Receives: Drug: BioChaperone insulin lispro |
| Humalog® | Active comparator | Humalog® Receives: Drug: Humalog® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (AUC)
Area under the curve of the insulin lispro concentration - time curve from 0 to 30 minutes
Measured: 30 minutes
Secondary outcomes (7)
Pharmacokinetics: Early t0.5max(Lisp)
Time to first observed half maximum observed insulin lispro concentration
Measured: up to 6 hours post administration of study drug
Glucodynamics: Area under the glucose infusion rate - time curve from t=0 to 6 hours
Measured: 6 hours
Glucodynamics: Early t0.5(GIRmax)
Time to first observed half maximum glucose infusion rate
Measured: 6 hours
Glucodynamic: GIRmax (Maximum glucose infusion rate)
Measured: 6 hours
Pharmacokinetics: Area under the insulin lispro serum concentration. Time curve from t=0 to 6 hours
Measured: 6 hours
Pharmacokinetics: tmax(Lisp) - Time from t=0 hours to maximum observed insulin lispro concentration
Measured: 6 hours
Safety and Tolerability: adverse events, local tolerability, vital signs variation, ECG, laboratory safety parameters
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionMar 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 1Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adocia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02029924
- Sponsor's protocol ID
- BC3-CT006
- Status last verified
- Sep 2014
- First submitted
- 16 Dec 2013
- Last updated
- 1 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blinded, Randomised, Two -Period Crossover Euglycemic Clamp Trial Investigating the Pharmacokinetics, Glucodynamics and Safety of BioChaperone Insulin Lispro and Insulin Lispro (Humalog®) in Subjects With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT02029924
- Acronym / sponsor ID
- BC3-CT006
- Conditions
- Diabetes Mellitus Type 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- AdociaIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 8 Jan 2014 (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.
The addition of Biochaperone to insulin lispro may accelerate the onset and shorten the duration of action of insulin lispro due to a facilitation of the absorption of the insulin after subcutaneous injection.
The aim of the trial is to assess the efficacy and safety of BioChaperone insulin lispro in subjects with Type 1 diabetes under a dose of 0.2 U/Kg.
This trial is a single-center, randomised, double-blinded, two-treatment, two-period cross-over, 6-hour euglycaemic glucose clamp trial in subjects with Type 1 diabetes mellitus. Each subject will be randomly allocated to a single dose of BioChaperone insulin lispro 0.2 U/Kg and a single dose of Humalog® 0.2 U/Kg on 2 separate dosing visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BioChaperone insulin lispro | Experimental | Drug: BioChaperone insulin lisproBioChaperone insulin lispro |
| Humalog® | Active comparator | Drug: Humalog®Humalog® |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Type 1 diabetes mellitus for at least 12 months.
- Treated with multiple daily insulin injections or insulin pump for at least 12 months.
- Body Mass Index (BMI): 18.0-28.0 Kg/m².
Key exclusion criteria (7 listed)
- Type 2 diabetes mellitus.
- Receipt of any investigational product within 3 months prior to first dosing.
- Clinically significant abnormalities as judged by the investigator.
- Any systemic treatment with drugs known to interfere with glucose metabolism.
- History of alcoholism, or drug/chemical abuse as per Investigator's judgement.
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 |
|---|---|---|
| BioChaperone insulin lisproSingle dose of 0.2 U/Kg body weight injected subcutaneously (under the skin) | Drug | BioChaperone insulin lispro |
| Humalog®Single dose of 0.2 /Kg body weight injected subcutaneously (under the skin) | Drug | Humalog® |
Primary outcome
Area under the curve (AUC)
Time frame: 30 minutes
Area under the curve of the insulin lispro concentration - time curve from 0 to 30 minutes
7 secondary outcomes
Pharmacokinetics: Early t0.5max(Lisp)
Time frame: up to 6 hours post administration of study drug
Glucodynamics: Area under the glucose infusion rate - time curve from t=0 to 6 hours
Time frame: 6 hours
Glucodynamics: Early t0.5(GIRmax)
Time frame: 6 hours
Glucodynamic: GIRmax (Maximum glucose infusion rate)
Time frame: 6 hours
Pharmacokinetics: Area under the insulin lispro serum concentration. Time curve from t=0 to 6 hours
Time frame: 6 hours
Pharmacokinetics: tmax(Lisp) - Time from t=0 hours to maximum observed insulin lispro concentration
Time frame: 6 hours
Safety and Tolerability: adverse events, local tolerability, vital signs variation, ECG, laboratory safety parameters
Time frame: 8 weeks
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 1 Jun 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 BioChaperone insulin lispro and Humalog® in people with Diabetes Mellitus Type 1, run by Adocia at 1 site in Germany.
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 3 inclusion and 7 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 1 Jun 2017. 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 Germany. 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?
Area under the curve (AUC) (time frame: 30 minutes). 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 1 Jun 2017; AzTrials last refreshed its copy on 27 Oct 2026.