DiabetesPhase 1NCT01981031
A Trial to Assess the Efficacy and Safety of BioChaperone Combo and Humalog Mix 25 in Subjects With Type 1 Diabetes
A Phase 1 study testing BioChaperone® Combo and Humalog® Mix25 in people with Diabetes and Diabetes Mellitus, Type 1, run by Adocia at 1 site in Germany.
Trial summary
BioChaperone Combo is a liquid formulation containing both Insulin Glargine and Insulin Lispro. The aim of this trial is to assess the efficacy and safety of BioChaperone® Combo in subjects with type 1 diabetes under a dose of 0.8 U/kg. Read more about this study
- Who is it for?
- Ages 18 to 64 years, men only
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1
- What is being tested?
- BioChaperone® Combo and Humalog® Mix25
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteGermany
- Study dates
- Nov 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 (or equal to ) 12 months,
- Treated with multiple daily insulin injections or insulin pump treatment for at least (or equal to) 12 months,
- Body Mass Index (BMI): 18.0-28.0kg/m2 (both inclusive)
Who cannot join
- Type 2 diabetes mellitus,
- The receipt of any investigational product within 3 month 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 and any tobacco product within 5 years prior to screening
- Blood or plasma donation in the past month or more than 500mL within 3 months prior to screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Study to Assess the Efficacy and Safety of BioChaperone® Combo and Humalog® Mix 25 in Subjects With Type 1 Diabetes
BioChaperone Combo is a liquid formulation containing both Insulin Glargine and Insulin Lispro.
The aim of this trial is to assess the efficacy and safety of BioChaperone® Combo in subjects with type 1 diabetes under a dose of 0.8 U/kg.
This trial is a phase 1 single-center, randomized, double-blinded, two-treatment, two-period cross-over, 30-hour euglycaemic glucose clamp trial in subjects with type 1 diabetes mellitus. Each subject will be randomly allocated to one single dose of 0.8 U/kg of BioChaperone® Combo and to one single dose of 0.8 U/kg of Humalog® Mix 25 on two separate dosing visits.
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Being tested
- BioChaperone® Combo, Humalog® Mix25
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioChaperone® ComboDrug
Single dose of 0.8U/kg body weight injected subcutaneously (under the skin)
Humalog® Mix25Drug
Single dose of 0.8U/kg body weight injected subcutaneously (under the skin)
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Drug: BioChaperone® Combo Receives: Drug: BioChaperone® Combo |
| B | Active comparator | Drug: Humalog® Mix25 Receives: Drug: Humalog® Mix25 |
What is being measured
The primary outcome is the main question the study is designed to answer.
End of action of 0.8 U/kg BioChaperone® Combo (time from administration until blood glucose concentration is consistently above 8.3 mmol/L during the glucose clamp procedure)
Measured: from 0 to 30 hours after a single-dose administration
Secondary outcomes (2)
Compare pharmacodynamics and pharmacokinetics profiles between BioChaperone® Combo and Humalog® Mix25
Measured: from 0 to 30 hours after a single-dose administration
Number of Adverse Events
hypoglycemic events, local tolerability, adverse reactions
Measured: Weeks 0-10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionDec 2013
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adocia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01981031
- Sponsor's protocol ID
- BC3-CT005
- Status last verified
- Sep 2014
- First submitted
- 31 Oct 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
- Phase 1 Study to Assess the Efficacy and Safety of BioChaperone® Combo and Humalog® Mix 25 in Subjects With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT01981031
- Acronym / sponsor ID
- BC3-CT005
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- AdociaIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 11 Nov 2013 (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.
BioChaperone Combo is a liquid formulation containing both Insulin Glargine and Insulin Lispro.
The aim of this trial is to assess the efficacy and safety of BioChaperone® Combo in subjects with type 1 diabetes under a dose of 0.8 U/kg.
This trial is a phase 1 single-center, randomized, double-blinded, two-treatment, two-period cross-over, 30-hour euglycaemic glucose clamp trial in subjects with type 1 diabetes mellitus. Each subject will be randomly allocated to one single dose of 0.8 U/kg of BioChaperone® Combo and to one single dose of 0.8 U/kg of Humalog® Mix 25 on two 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 |
|---|---|---|
| A | Experimental | Drug: BioChaperone® ComboDrug: BioChaperone® Combo |
| B | Active comparator | Drug: Humalog® Mix25Drug: Humalog® Mix25 |
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 (or equal to ) 12 months,
- Treated with multiple daily insulin injections or insulin pump treatment for at least (or equal to) 12 months,
- Body Mass Index (BMI): 18.0-28.0kg/m2 (both inclusive)
Key exclusion criteria (6 listed)
- Type 2 diabetes mellitus,
- The receipt of any investigational product within 3 month 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 and any tobacco product within 5 years prior to screening
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® ComboSingle dose of 0.8U/kg body weight injected subcutaneously (under the skin) | Drug | A |
| Humalog® Mix25Single dose of 0.8U/kg body weight injected subcutaneously (under the skin) | Drug | B |
Primary outcome
End of action of 0.8 U/kg BioChaperone® Combo (time from administration until blood glucose concentration is consistently above 8.3 mmol/L during the glucose clamp procedure)
Time frame: from 0 to 30 hours after a single-dose administration
2 secondary outcomes
Compare pharmacodynamics and pharmacokinetics profiles between BioChaperone® Combo and Humalog® Mix25
Time frame: from 0 to 30 hours after a single-dose administration
Number of Adverse Events
Time frame: Weeks 0-10
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® Combo and Humalog® Mix25 in people with Diabetes and 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 6 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?
End of action of 0.8 U/kg BioChaperone® Combo (time from administration until blood glucose concentration is consistently above 8.3 mmol/L during the glucose clamp procedure) (time frame: from 0 to 30 hours after a single-dose administration). 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.