Diabetes Mellitus Type 1Phase 1NCT02344992
Blood Glucose Control With BioChaperone Insulin Lispro Compared to Insulin Lispro (Humalog®) After Ingestion of a Standardized Meal
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 already marketed prandial insulin analogue accelerates the onset and shorten the duration of action of insulin lispro due to facilitation of the absorption of the insulin after subcutaneous injection. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- 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
- 38 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2015to Jun 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
- No healthy volunteers
- Adult
Who may be able to join
- Type 1 Diabetes Mellitus ≥ 12 months
- Treated with multiple daily insulin injections or CSII ≥ 12 months
- BMI 18.5-28.0 kg/m² (both inclusive)
- HbA1C%≤9%
Who cannot join
- Type 2 Diabetes Mellitus
- Receipt of any trial product within 60 days prior to this trial
- Clinically significant abnormal haematology, biochemistry, lipids or urinalysis screening tests as judged by the investigator considering the underlying disease
- Presence of clinically significant acute gastroinstestinal symptoms as judged by the investigator
- Known slowing of gastric emptying and or gastrointestinal surgery that in the opinion of the investigator might change gastrointestinal motility and food absorption.
- Any systemic treatment with drugs known to interfere with glucose metabolism
- Use of any tobacco or nicotine-contained product within one year prior to screening
Trial locations and contacts
1 site in 1 country.
About this study
The addition of BioChaperone to already marketed prandial insulin analogue accelerates the onset and shorten the duration of action of insulin lispro due to facilitation of the absorption of the insulin after subcutaneous injection.
This trial is intented to compare the post-prandial blood glucose control of BioChaperone insulin lispro and Humalog® when injected after a standardized meal as well as the pharmacokinetic profile of BioChaperone insulin lispro and Humalog® in subjects with type 1 diabetes mellitus.
This is a double-blinded, randomized, controlled, two-period crossover phase Ib trial to compare the blood glucose control after ingestion of a standardized meal, with BioChaperone Lispro at 0.2U/Kg and Humalog at 0.2U/Kg.
- 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
Humalog®Drug
Single dose of 0.2 U/kg body weight injected subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| Biochaperone Insulin Lispro | Experimental | Not described Receives: Drug: BioChaperone insulin lispro |
| Humalog® | Active comparator | Not described Receives: Drug: Humalog® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the blood glucose time curve: AUCbg(0-2h)
Area under the blood glucose concentration time curve from 0-2 hours after a standardised meal
Measured: 2 hours
Secondary outcomes (5)
Pharmacodynamic: Area under the blood glucose concentration time curve from 0-8 hours after a standardized meal: AUCbg(0-8h)
Measured: 8 hours
Pharmacodynamic: maximum blood glucose concentration after a standardized meal: BGmax
Measured: 8 hours
Pharmacokinetic: Area under the serum insulin lispro concentration time curve from 0-8hours: AUClisp(0-8h)
Measured: 8 hours
Pharmacokinetic: Maximum observed serum insulin lispro concentration: Cmax(lisp)
Measured: 8 hours
Safety and tolerability: adverse events, local tolerability, vital signs variation, ECG, laboratory safety parameters
Measured: Up to 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionJun 2015
- Study completionJun 2015
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adocia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Grit Andersen, MD, Principal investigator, Profil GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02344992
- Sponsor's protocol ID
- BC3-CT011
- Other IDs
- 2014-005028-92, 2014
- Status last verified
- Jun 2015
- First submitted
- 19 Jan 2015
- 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
- Blood Glucose Control With BioChaperone Insulin Lispro Compared to Insulin Lispro (Humalog®) After Ingestion of a Standardized Meal
- ClinicalTrials.gov ID
- NCT02344992
- Acronym / sponsor ID
- BC3-CT011
- Conditions
- Diabetes Mellitus Type 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- AdociaIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 26 Jan 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.
The addition of BioChaperone to already marketed prandial insulin analogue accelerates the onset and shorten the duration of action of insulin lispro due to facilitation of the absorption of the insulin after subcutaneous injection.
This trial is intented to compare the post-prandial blood glucose control of BioChaperone insulin lispro and Humalog® when injected after a standardized meal as well as the pharmacokinetic profile of BioChaperone insulin lispro and Humalog® in subjects with type 1 diabetes mellitus.
This is a double-blinded, randomized, controlled, two-period crossover phase Ib trial to compare the blood glucose control after ingestion of a standardized meal, with BioChaperone Lispro at 0.2U/Kg and Humalog at 0.2U/Kg.
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 Insulin Lispro | Experimental | Drug: BioChaperone insulin lispro |
| Humalog® | Active comparator | Drug: Humalog® |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Type 1 Diabetes Mellitus ≥ 12 months
- Treated with multiple daily insulin injections or CSII ≥ 12 months
- BMI 18.5-28.0 kg/m² (both inclusive)
- HbA1C%≤9%
Key exclusion criteria (7 listed)
- Type 2 Diabetes Mellitus
- Receipt of any trial product within 60 days prior to this trial
- Clinically significant abnormal haematology, biochemistry, lipids or urinalysis screening tests as judged by the investigator considering the underlying disease
- Presence of clinically significant acute gastroinstestinal symptoms as judged by the investigator
- Known slowing of gastric emptying and or gastrointestinal surgery that in the opinion of the investigator might change gastrointestinal motility and food absorption.
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 | Drug | Biochaperone Insulin Lispro |
| Humalog®Single dose of 0.2 U/kg body weight injected subcutaneously | Drug | Humalog® |
Primary outcome
Area under the blood glucose time curve: AUCbg(0-2h)
Time frame: 2 hours
Area under the blood glucose concentration time curve from 0-2 hours after a standardised meal
5 secondary outcomes
Pharmacodynamic: Area under the blood glucose concentration time curve from 0-8 hours after a standardized meal: AUCbg(0-8h)
Time frame: 8 hours
Pharmacodynamic: maximum blood glucose concentration after a standardized meal: BGmax
Time frame: 8 hours
Pharmacokinetic: Area under the serum insulin lispro concentration time curve from 0-8hours: AUClisp(0-8h)
Time frame: 8 hours
Pharmacokinetic: Maximum observed serum insulin lispro concentration: Cmax(lisp)
Time frame: 8 hours
Safety and tolerability: adverse events, local tolerability, vital signs variation, ECG, laboratory safety parameters
Time frame: Up to 7 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.
Grit Andersen, MD principal investigator
Profil 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 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 4 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 blood glucose time curve: AUCbg(0-2h) (time frame: 2 hours). 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.