Type1 Diabetes MellitusPhase 1NCT03179332
A Trial to Evaluate the Pharmacokinetic and Pharmacodynamic Properties of BioChaperone® Insulin Lispro, Fiasp® and NovoRapid® Delivered by an Insulin Pump
A Phase 1 study testing BioChaperone® insulin lispro, Fiasp® and Novorapid® in people with Type1 Diabetes Mellitus, run by Adocia at 1 site in Germany.
Trial summary
This is a single-centre, randomised, double-blind, three-period, complete cross-over trial comparing the pharmacokinetic and the pharmacodynamic properties of BioChaperone® insulin lispro and the two active comparators Fiasp® and Novorapid® when given as a bolus on top of basal delivery with an insulin pump in… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Type1 Diabetes Mellitus
- What is being tested?
- BioChaperone® insulin lispro, Fiasp® and Novorapid®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteGermany
- Study dates
- 20 Jun 2017to 27 Sep 2017
- 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 for more than 12 months.
- BMI between 18.5 and 28.5 kg/m².
- HbA1C level <=9.0%.
- Insulin treated for at least 12 months with total insulin dose <1.2U/kg/day.
Who cannot join
- Type 2 Diabetes Mellitus.
- History of multiple and/or severe allergies to drugs or foods.
- Any history or presence of clinically relevant cardiovascular, pulmonary, respiratory, gastrointestinal, hepatic, renal, metabolic, endocrinological (with the exception of conditions associated with diabetes mellitus), haematological, dermatological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynaecologic (if female), or infectious disease, or signs of acute illness as judged by the Investigator.
- More than one episode of severe hypoglycaemia with seizure, coma or requiring assistance of another person during the past 6 months.
- Proliferative retinopathy or maculopathy and/or severe neuropathy, in particular autonomic neuropathy.
- Females of childbearing potential, who are pregnant, breast-feeding or intend to become pregnant or are not using highly effective contraceptive methods.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Euglycaemic Clamp Trial to Evaluate the Pharmacokinetic and Pharmacodynamic Properties of a Bolus Dose of BioChaperone® Insulin Lispro, Fiasp® and NovoRapid® by an Insulin Pump
This is a single-centre, randomised, double-blind, three-period, complete cross-over trial comparing the pharmacokinetic and the pharmacodynamic properties of BioChaperone® insulin lispro and the two active comparators Fiasp® and Novorapid® when given as a bolus on top of basal delivery with an insulin pump in subjects with type 1 diabetes mellitus. Each subject will be randomly assigned to a treatment sequence consisting of 3 dosing visits during which the subject will receive the investigational products. In a euglycaemic clamp setting, subjects will be given a bolus dose of 0.15 U/kg body weight.
Throughout the glucose clamp procedure, blood glucose will be stabilised at a target level of 100 mg/dL by means of an intravenous infusion of glucose. Blood samples for pharmacokinetic assessment will be drawn at specified timepoints and glucose infusion rates and blood glucose concentrations will be recorded for pharmacodynamic assessment during the 10-hour clamp procedure after dosing.
- Conditions
- Type1 Diabetes Mellitus
- Being tested
- BioChaperone® insulin lispro, Fiasp®, Novorapid®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioChaperone® insulin lisproDrug
Single subcutaneous administration of a bolus of 0.15 U/kg body with a pump
Fiasp®Drug
Single subcutaneous administration of a bolus of 0.15 U/kg body with a pump
Novorapid®Drug
Single subcutaneous administration of a bolus of 0.15 U/kg body with a pump
| Study group | Role | What they receive |
|---|---|---|
| BioChaperone® insulin lispro | Experimental | Single subcutaneous administration of BioChaperone® insulin lispro Receives: Drug: BioChaperone® insulin lispro |
| Fiasp® | Active comparator | Single subcutaneous administration of Fiasp® (insulin aspart) Receives: Drug: Fiasp® |
| Novorapid® | Active comparator | Single subcutaneous administration of Novorapid® (insulin aspart) Receives: Drug: Novorapid® |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCGIR(0-60min)
Baseline corrected area under the glucose infusion rate curve from 0 to 60 minutes after bolus administration
Measured: 60 minutes
Secondary outcomes (9)
AUCins(0-30min)
Baseline corrected area under the insulin concentration time curve from 0 to 30 minutes after bolus administration
Measured: 30 minutes
AUCins(0-60min)
Baseline corrected area under the insulin concentration time curve from 0 to 60 minutes after bolus administration
Measured: 60 minutes
AUCins(0-600min)
Baseline corrected area under the insulin concentration time curve from 0 to 600 minutes after bolus administration
Measured: 600 minutes
Cmax insulin
Maximum observed baseline corrected insulin concentration
Measured: 10 hours
Tmax insulin
Time from bolus administration to baseline corrected Cmax
Measured: 10 hours
TmaxGIR
Time from bolus administration to maximum baseline corrected glucose infusion rate
Measured: 10 hours
GIRmax
Maximum baseline corrected glucose infusion rate
Measured: 10 hours
Adverse Events
Number of Adverse Events in each arm
Measured: up to 8 weeks
Clinical safety laboratory
Haematology, biochemistry and urinalysis: changes and findings from Baseline in clinical safety laboratory parameters during the trial duration, from screening, and at follow-up visit.
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2017
- Study start20 Jun 2017
- Primary completion27 Sep 2017
- Study completion27 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adocia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Oliver Klein, MD, Principal investigator, Profil Institut für Stoffwechselforschung GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03179332
- Sponsor's protocol ID
- CT032-ADO02
- Status last verified
- Dec 2017
- First submitted
- 4 May 2017
- Last updated
- 12 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Euglycaemic Clamp Trial to Evaluate the Pharmacokinetic and Pharmacodynamic Properties of a Bolus Dose of BioChaperone® Insulin Lispro, Fiasp® and NovoRapid® by an Insulin Pump
- ClinicalTrials.gov ID
- NCT03179332
- Acronym / sponsor ID
- CT032-ADO02
- Conditions
- Type1 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- AdociaIndustry (pharma, biotech, devices)
- Study start
- 20 Jun 2017 (actual)
- Primary completion
- 27 Sep 2017 (actual)
- Study completion
- 27 Sep 2017 (actual)
- First posted
- 7 Jun 2017 (actual)
- 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 single-centre, randomised, double-blind, three-period, complete cross-over trial comparing the pharmacokinetic and the pharmacodynamic properties of BioChaperone® insulin lispro and the two active comparators Fiasp® and Novorapid® when given as a bolus on top of basal delivery with an insulin pump in subjects with type 1 diabetes mellitus. Each subject will be randomly assigned to a treatment sequence consisting of 3 dosing visits during which the subject will receive the investigational products. In a euglycaemic clamp setting, subjects will be given a bolus dose of 0.15 U/kg body weight.
Throughout the glucose clamp procedure, blood glucose will be stabilised at a target level of 100 mg/dL by means of an intravenous infusion of glucose. Blood samples for pharmacokinetic assessment will be drawn at specified timepoints and glucose infusion rates and blood glucose concentrations will be recorded for pharmacodynamic assessment during the 10-hour clamp procedure after dosing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BioChaperone® insulin lispro | Experimental | Drug: BioChaperone® insulin lisproSingle subcutaneous administration of BioChaperone® insulin lispro |
| Fiasp® | Active comparator | Drug: Fiasp®Single subcutaneous administration of Fiasp® (insulin aspart) |
| Novorapid® | Active comparator | Drug: Novorapid®Single subcutaneous administration of Novorapid® (insulin aspart) |
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 for more than 12 months.
- BMI between 18.5 and 28.5 kg/m².
- HbA1C level <=9.0%.
- Insulin treated for at least 12 months with total insulin dose <1.2U/kg/day.
Key exclusion criteria (6 listed)
- Type 2 Diabetes Mellitus.
- History of multiple and/or severe allergies to drugs or foods.
- Any history or presence of clinically relevant cardiovascular, pulmonary, respiratory, gastrointestinal, hepatic, renal, metabolic, endocrinological (with the exception of conditions associated with diabetes mellitus), haematological, dermatological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynaecologic (if female), or infectious disease, or signs of acute illness as judged by the Investigator.
- More than one episode of severe hypoglycaemia with seizure, coma or requiring assistance of another person during the past 6 months.
- Proliferative retinopathy or maculopathy and/or severe neuropathy, in particular autonomic neuropathy.
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 subcutaneous administration of a bolus of 0.15 U/kg body with a pump | Drug | BioChaperone® insulin lispro |
| Fiasp®Single subcutaneous administration of a bolus of 0.15 U/kg body with a pump | Drug | Fiasp® |
| Novorapid®Single subcutaneous administration of a bolus of 0.15 U/kg body with a pump | Drug | Novorapid® |
Primary outcome
AUCGIR(0-60min)
Time frame: 60 minutes
Baseline corrected area under the glucose infusion rate curve from 0 to 60 minutes after bolus administration
9 secondary outcomes
AUCins(0-30min)
Time frame: 30 minutes
AUCins(0-60min)
Time frame: 60 minutes
AUCins(0-600min)
Time frame: 600 minutes
Cmax insulin
Time frame: 10 hours
Tmax insulin
Time frame: 10 hours
TmaxGIR
Time frame: 10 hours
GIRmax
Time frame: 10 hours
Adverse Events
Time frame: up to 8 weeks
Clinical safety laboratory
Time frame: up to 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 12 Dec 2017.
- Individual participant dataSharing planned: No
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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.
Oliver Klein, MD principal investigator
Profil Institut für Stoffwechselforschung 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, Fiasp® and Novorapid® in people with Type1 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 4 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 12 Dec 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?
AUCGIR(0-60min) (time frame: 60 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 12 Dec 2017.