HealthyPhase 1NCT02529293
A Clinical Trial Investigating the Intra-subject Variability of Pharmacokinetics and Glucodynamics of BioChaperone Insulin Lispro U-100 Product and U-200 Product in Healthy Volunteers
A Phase 1 study testing BioChaperone Lispro U-100 and BioChaperone Lispro U-200 in people with Healthy, run by Adocia at 1 site in Germany.
Trial summary
This is a double-blinded, randomised, single-centre phase I pilot trial for exploring the feasibility of a pivotal clinical trial establishing bioequivalence between BioChaperone insulin lispro U-200 and BioChaperone insulin lispro U-100 in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BioChaperone Lispro U-100 and BioChaperone Lispro U-200
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2015to Nov 2015
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female subjects, considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the Investigator.
- Age ≥ 18 and ≤ 64 years, both inclusive.
- Body Mass Index (BMI) between 18.5 and 28.0 kg∙m-2, both inclusive.
- Fasting Plasma Glucose (FPG) ≤ 5.6 mmol/L (100 mg/dL).
- Signed and dated informed consent obtained before any trial-related activities, i.e. any procedures that would not have been performed during normal management of the subject).
Who cannot join
- Known or suspected hypersensitivity to trial product(s) or related products.
- Receipt of any investigational medicinal product within 3 months before randomisation in this trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Clinical Trial Investigating the Intra-subject Variability of Pharmacokinetics and Glucodynamics of BioChaperone Insulin Lispro U-100 Product (2 Single Doses of 0.2 U/kg) and U-200 Product (2 Single Doses of 0.2 U/kg) in Healthy Male and Female
This is a double-blinded, randomised, single-centre phase I pilot trial for exploring the feasibility of a pivotal clinical trial establishing bioequivalence between BioChaperone insulin lispro U-200 and BioChaperone insulin lispro U-100 in healthy subjects.
Each subject will be randomly allocated to a sequence of four treatments, i.e. two single doses of BioChaperone insulin lispro U-200 of 0.2 U·kg BW-1 and two single doses of BioChaperone insulin lispro U-100 of 0.2 U·kg BW-1 on four separate dosing visits.
- Conditions
- Healthy
- Being tested
- BioChaperone Lispro U-100, BioChaperone Lispro U-200
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioChaperone Lispro U-100Drug
Injection of BioChaperone Lispro U-100
BioChaperone Lispro U-200Drug
Injection of BioChaperone Lispro U-200
| Study group | Role | What they receive |
|---|---|---|
| BioChaperone Lispro U-100 | Active comparator | injection of 2 doses of 0.2 U/kg on separate visits Receives: Drug: BioChaperone Lispro U-100 |
| BioChaperone Lispro U-200 | Experimental | injection of 2 doses of 0.2 U/kg on separate visits Receives: Drug: BioChaperone Lispro U-200 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCLisp (0-inf)
Area under the insulin lispro serum concentration - time curve from t=0 to infinity
Measured: 8 hours
Cmax Lisp
Maximum observed insulin lispro serum concentration
Measured: 8 hours
Secondary outcomes (6)
tmax Lisp
Time to maximum observed serum insulin lispro concentration
Measured: 8 hours
AUCGIR(0-8h)
Area under the glucose infusion rate-time curve from t=0 to 8 hours
Measured: 8 hours
GIRmax
Maximum glucose infusion rate
Measured: 8 hours
tGIRmax
Time to maximum glucose infusion rate
Measured: 8 hours
Number of Adverse events
Number of adverse events
Measured: Up to 9 weeks
Local tolerability
Record of injection site reaction
Measured: Up to 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adocia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Grit Andersen, MD, Principal investigator, Profil Institut Für Stoffwechselfforschung GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02529293
- Sponsor's protocol ID
- BC3-CT012
- Status last verified
- Dec 2015
- First submitted
- 18 Aug 2015
- Last updated
- 18 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Clinical Trial Investigating the Intra-subject Variability of Pharmacokinetics and Glucodynamics of BioChaperone Insulin Lispro U-100 Product (2 Single Doses of 0.2 U/kg) and U-200 Product (2 Single Doses of 0.2 U/kg) in Healthy Male and Female
- ClinicalTrials.gov ID
- NCT02529293
- Acronym / sponsor ID
- BC3-CT012
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- AdociaIndustry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 20 Aug 2015 (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.
This is a double-blinded, randomised, single-centre phase I pilot trial for exploring the feasibility of a pivotal clinical trial establishing bioequivalence between BioChaperone insulin lispro U-200 and BioChaperone insulin lispro U-100 in healthy subjects.
Each subject will be randomly allocated to a sequence of four treatments, i.e. two single doses of BioChaperone insulin lispro U-200 of 0.2 U·kg BW-1 and two single doses of BioChaperone insulin lispro U-100 of 0.2 U·kg BW-1 on four separate dosing visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BioChaperone Lispro U-100 | Active comparator | Drug: BioChaperone Lispro U-100injection of 2 doses of 0.2 U/kg on separate visits |
| BioChaperone Lispro U-200 | Experimental | Drug: BioChaperone Lispro U-200injection of 2 doses of 0.2 U/kg on separate visits |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female subjects, considered generally healthy upon completion of medical history, physical examination and biochemical investigations as judged by the Investigator.
- Age ≥ 18 and ≤ 64 years, both inclusive.
- Body Mass Index (BMI) between 18.5 and 28.0 kg∙m-2, both inclusive.
- Fasting Plasma Glucose (FPG) ≤ 5.6 mmol/L (100 mg/dL).
- Signed and dated informed consent obtained before any trial-related activities, i.e. any procedures that would not have been performed during normal management of the subject).
Key exclusion criteria (2 listed)
- Known or suspected hypersensitivity to trial product(s) or related products.
- Receipt of any investigational medicinal product within 3 months before randomisation in this trial.
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 Lispro U-100Injection of BioChaperone Lispro U-100 | Drug | BioChaperone Lispro U-100 |
| BioChaperone Lispro U-200Injection of BioChaperone Lispro U-200 | Drug | BioChaperone Lispro U-200 |
Primary outcome
AUCLisp (0-inf)
Time frame: 8 hours
Area under the insulin lispro serum concentration - time curve from t=0 to infinity
Cmax Lisp
Time frame: 8 hours
Maximum observed insulin lispro serum concentration
6 secondary outcomes
tmax Lisp
Time frame: 8 hours
AUCGIR(0-8h)
Time frame: 8 hours
GIRmax
Time frame: 8 hours
tGIRmax
Time frame: 8 hours
Number of Adverse events
Time frame: Up to 9 weeks
Local tolerability
Time frame: Up to 9 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 18 Dec 2015.
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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.
Grit Andersen, MD principal investigator
Profil Institut Für Stoffwechselfforschung GmbH
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 Lispro U-100 and BioChaperone Lispro U-200 in people with Healthy, 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 5 inclusion and 2 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 18 Dec 2015. 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?
AUCLisp (0-inf) (time frame: 8 hours). The study lists 2 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 18 Dec 2015.