Type 1 Diabetes MellitusPhase 1NCT02562313
A Trial Investigating the Continuous Subcutaneous Insulin Infusion of a Liquid Formulation of BioChaperone Insulin Lispro in Comparison to Humalog®
A Phase 1 study testing BioChaperone insulin lispro and Humalog® in people with Type 1 Diabetes Mellitus, run by Adocia at 1 site in Germany.
Trial summary
This study is constituted of 2 parts: Part A: A total of 36 patients will be enrolled in part A. Each eligible subject will participate in two 14-day treatment periods with Continuous Subcutaneous Insulin Infusion (CSII) of BioChaperone insulin lispro and insulin lispro (Humalog®, Eli Lilly and Company). Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- 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
- 80 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2015to Nov 2016
- 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 for at least 12 months
- Body Mass Index (BMI) between 18.5 and 28.5 kg/m^2, both inclusive
- Using or having used a Roche CSII system (Accu-Chek® Spirit Combo/ Accu- Chek® Spirit) for at least 6 months before screening. In Part B subjects using any form of CSII treatment for at least 6 months before screening will be included.
- HbA1c <= 9.0%.
- Total insulin dose of < 1.2 (I)U/kg/day
- Ability to calculate insulin bolus manually or using a bolus calculator and willingness to consume regular meals, perform carbohydrate counting, self-monitoring of plasma glucose (SMPG) profiles and use of Continuous Glucose Monitoring (CGM).
- Fasting C-peptide <= 0.30 nmol/L
Who cannot join
- Known or suspected hypersensitivity to Investigational Medicinal Product(s) (IMP(s)) or related products
- Type 2 diabetes mellitus
- Previous participation in this trial.
- Receipt of any investigational product in a clinical trial within 60 days before randomisation in this trial
- Clinically significant abnormal haematology, biochemistry, urinalysis, or coagulation screening test
- Presence of clinically significant acute gastrointestinal symptoms
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- Known slowing of gastric emptying and or gastrointestinal surgery
- Unusual meal habits and special dietary requirements or unwillingness to eat the food provided in the trial
- History of diabetic ketoacidosis (DKA) episodes requiring hospitalization within 6 months prior to screening
- History of abscess at the infusion site within 6 months prior to screening
- Hypoglycaemia unawareness as judged by the Investigator
- History of severe hypoglycaemic episodes requiring hospitalization within the last 6 months prior to screening
Trial locations and contacts
1 site in 1 country.
About this study
This study is constituted of 2 parts:
Part A: A total of 36 patients will be enrolled in part A. Each eligible subject will participate in two 14-day treatment periods with Continuous Subcutaneous Insulin Infusion (CSII) of BioChaperone insulin lispro and insulin lispro (Humalog®, Eli Lilly and Company). Each treatment period consists of 10 treatment days under free living conditions (e.g. home / workplace) and under standardised conditions at the clinic. Various assessments for pharmacodynamics, pharmacokinetics, pump compatibility, short-term efficacy and safety are performed on selected days, including:
Read more
- Mixed Meal Test (MMT), Day 1, Day 3, Day 12 and Day 14, that will assess the post-prandial glucose response for 6 hours after individualized standard meal (fixed nutrient ratio) ingestion and bolus administration via CSII.
- Continuous Glucose Monitoring (CGM), (Day 1 - 14) that will be used in blinded mode (i.e. neither subjects nor the investigators are aware of the sensor glucose values).
- Pump compatibility (Day 1 - 14): Subjects will continue CSII treatment with the Investigational Medicinal Products (IMP) during the outpatient periods.
Part B: A total of 44 patients will be enrolled. Subjects will be randomized to a 4-period cross-over study aiming at comparing the performance of BC Lispro and Humalog after a prandial bolus administration with two different CSII systems (Roche Accu-Chek® Spirit and Medtronic Paradigm® Veo™) or with a syringe. Pharmacodynamics, pharmacokinetics, pump compatibility and safety will be analyzed.
Each period will include a mixed meal tolerance test with a CSII device and a mixed meal tolerance test with the same dose of insulin administered with a syringe.
- Conditions
- Type 1 Diabetes Mellitus
- 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
BioChaperone insulin lispro bolus infusion followed by test meal intake
Humalog®Drug
Humalog® bolus infusion followed by test meal intake
| Study group | Role | What they receive |
|---|---|---|
| BioChaperone insulin lispro | Experimental | Not described Receives: Drug: BioChaperone insulin lispro |
| Humalog® | Active comparator | Insulin lispro Receives: Drug: Humalog® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacodynamics: ΔAUCBG 0-2h
Incremental Area Under the Blood Glucose concentration-time Curve from 0-2 hours after the start of the meal.
Measured: 2 Hours
Pharmacokinetics: AUClis 0-30min
Area Under the serum insulin Lispro concentration-time Curve from 0-30 minutes
Measured: 30 minutes
Secondary outcomes (8)
AUClis_0-6h
Area Under the baseline adjusted insulin Lispro Curve from 0-6h following a bolus dose
Measured: up to 6 Hours
Cmax
Maximum insulin Concentration following a bolus dose
Measured: up to 6 Hours
tCmax
Time to Maximum insulin Concentration following a bolus dose
Measured: up to 6 Hours
BGmax
Maximum Blood Glucose after start of an individualised standardised meal intake
Measured: up to 6 Hours
tBGmax
Time to Maximum Blood Glucose concentration
Measured: up to 6 Hours
Compatibility
Number of suspected episodes of infusion set occlusion or leakage
Measured: up to 14 days
Adverse Events
Number of Adverse Events
Measured: up to 12 weeks
Local tolerability
Number of injection site reactions
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adocia
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Tim Heise, MD, Principal investigator, Profil GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02562313
- Sponsor's protocol ID
- BC3-CT015
- Status last verified
- Nov 2016
- First submitted
- 28 Sep 2015
- Last updated
- 22 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial Investigating the Continuous Subcutaneous Insulin Infusion of a Liquid Formulation of BioChaperone Insulin Lispro in Comparison to Humalog®
- ClinicalTrials.gov ID
- NCT02562313
- Acronym / sponsor ID
- BC3-CT015
- Conditions
- Type 1 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- AdociaIndustry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Study start
- Sep 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 29 Sep 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 study is constituted of 2 parts:
Part A: A total of 36 patients will be enrolled in part A. Each eligible subject will participate in two 14-day treatment periods with Continuous Subcutaneous Insulin Infusion (CSII) of BioChaperone insulin lispro and insulin lispro (Humalog®, Eli Lilly and Company). Each treatment period consists of 10 treatment days under free living conditions (e.g. home / workplace) and under standardised conditions at the clinic. Various assessments for pharmacodynamics, pharmacokinetics, pump compatibility, short-term efficacy and safety are performed on selected days, including:
- Mixed Meal Test (MMT), Day 1, Day 3, Day 12 and Day 14, that will assess the post-prandial glucose response for 6 hours after individualized standard meal (fixed nutrient ratio) ingestion and bolus administration via CSII.
- Continuous Glucose Monitoring (CGM), (Day 1 - 14) that will be used in blinded mode (i.e. neither subjects nor the investigators are aware of the sensor glucose values).
- Pump compatibility (Day 1 - 14): Subjects will continue CSII treatment with the Investigational Medicinal Products (IMP) during the outpatient periods.
Part B: A total of 44 patients will be enrolled. Subjects will be randomized to a 4-period cross-over study aiming at comparing the performance of BC Lispro and Humalog after a prandial bolus administration with two different CSII systems (Roche Accu-Chek® Spirit and Medtronic Paradigm® Veo™) or with a syringe. Pharmacodynamics, pharmacokinetics, pump compatibility and safety will be analyzed.
Each period will include a mixed meal tolerance test with a CSII device and a mixed meal tolerance test with the same dose of insulin administered with a syringe.
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®Insulin lispro |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Type 1 diabetes for at least 12 months
- Body Mass Index (BMI) between 18.5 and 28.5 kg/m^2, both inclusive
- Using or having used a Roche CSII system (Accu-Chek® Spirit Combo/ Accu- Chek® Spirit) for at least 6 months before screening. In Part B subjects using any form of CSII treatment for at least 6 months before screening will be included.
- HbA1c <= 9.0%.
- Total insulin dose of < 1.2 (I)U/kg/day
Key exclusion criteria (12 listed)
- Known or suspected hypersensitivity to Investigational Medicinal Product(s) (IMP(s)) or related products
- Type 2 diabetes mellitus
- Previous participation in this trial.
- Receipt of any investigational product in a clinical trial within 60 days before randomisation in this trial
- Clinically significant abnormal haematology, biochemistry, urinalysis, or coagulation screening test
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 lisproBioChaperone insulin lispro bolus infusion followed by test meal intake | Drug | BioChaperone insulin lispro |
| Humalog®Humalog® bolus infusion followed by test meal intake | Drug | Humalog® |
Primary outcome
Pharmacodynamics: ΔAUCBG 0-2h
Time frame: 2 Hours
Incremental Area Under the Blood Glucose concentration-time Curve from 0-2 hours after the start of the meal.
Pharmacokinetics: AUClis 0-30min
Time frame: 30 minutes
Area Under the serum insulin Lispro concentration-time Curve from 0-30 minutes
8 secondary outcomes
AUClis_0-6h
Time frame: up to 6 Hours
Cmax
Time frame: up to 6 Hours
tCmax
Time frame: up to 6 Hours
BGmax
Time frame: up to 6 Hours
tBGmax
Time frame: up to 6 Hours
Compatibility
Time frame: up to 14 days
Adverse Events
Time frame: up to 12 weeks
Local tolerability
Time frame: up to 12 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 22 Nov 2016.
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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.
Tim Heise, 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 Type 1 Diabetes Mellitus, 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 7 inclusion and 12 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 22 Nov 2016. 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?
Pharmacodynamics: ΔAUCBG 0-2h (time frame: 2 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 22 Nov 2016.