Type 1 DiabetesPhase 1NCT04501107

A Trial to Compare BioChaperone Insulin Lispro Formulations With US Approved Humalog® and With EU Approved Humalog® in Patients With Type 1 Diabetes Mellitus

A Phase 1 study testing Administration of BioChaperone insulin lispro reconstituted with Humalog® (IMP1), Administration of Ready-to-use BioChaperone insulin lispro (IMP2) and Administration of US-approved Humalog® (IMP3) in people with Type 1 Diabetes, run by Adocia at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 64 years
Conditions the study is for: Type 1 Diabetes
What is being tested?: Administration of BioChaperone insulin lispro reconstituted with Humalog® (IMP1), Administration of Ready-to-use BioChaperone insulin lispro (IMP2) and Administration of US-approved Humalog® (IMP3)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteGermany
Study dates: 3 Aug 2020to 3 Nov 2020
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

Subjects with type 1 Diabetes Mellitus
Body Mass Index (BMI) between 18.5 and 28.5 kg/m^2, both inclusive
HbA1c <= 75 mmol/mol (<=9.0%).
Fasting negative C-peptide (<= 0.30 nmol/L).
Total insulin dose of < 1.2 (I)U/kg/day.
Stable insulin regimen (with respect to safety of the subject and scientific integrity of the study) using continuous subcutaneous insulin infusion (CSII) or multiple daily insulin injections (MDI) for at least 2 months.

Who cannot join

Known or suspected hypersensitivity to IMP(s) or related products.
Receipt of any medicinal product in clinical development within 30 days or at least 5 half-lives of the related substances and their metabolites (whichever is longer) before randomisation in this trial.
History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
Any history or presence of cancer except basal cell skin cancer or squamous cell skin cancer as judged by the Investigator.
Any history or presence of clinically relevant comorbidity capable of constituting a risk for the subject when participating in the trial or of interfering with the interpretation of data.
Signs of acute illness as judged by the Investigator.

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Any serious systemic infectious disease during four weeks prior to first dosing of the trial drug, as judged by the Investigator.
Clinically significant abnormal screening laboratory tests, as judged by the Investigator.
Proliferative retinopathy or maculopathy as judged by the Investigator based on a recent (<1.5 years) ophthalmologic examination.
Use of oral antidiabetic drugs (OADs) and/or GLP-1 receptor agonists within 3 months prior to screening.

Trial locations and contacts

1 site in 1 country.

Germany1 site

Profil GmbH
Mainz, D-55116

Other trials in Germany

About this study

Official title: A Randomised, Double Blind, Crossover Euglycaemic Clamp Trial to Compare BioChaperone Insulin Lispro Formulations With US Approved Humalog® and With EU Approved Humalog® in Patients With Type 1 Diabetes Mellitus

This is a single-centre, randomised, double-blind, 4-way crossover, 4-treatment, euglycaemic clamp study in subjects with Type 1 Diabetes Mellitus (T1DM). Each subject will be randomly allocated to one of four treatment sequences. Each sequence comprises one single dose of each of four IMPs. IMP1 and IMP2 are BioChaperone lispro formulations. They have the same composition and correspond to different development stages of a unique product which is BioChaperone insulin lispro; between them, improvements were made to prepare industrial production. Comparators (IMP3 and IMP4) are US-approved Humalog® and EU-approved Humalog®. All IMPs will be dosed at 0.2 U/Kg of insulin lispro on 4 dosing visits separated by a washout period of 5 to 15 days.

The trial will compare the characteristics of BioChaperone insulin lispro fully liquid (IMP2) formulation to US-approved Humalog and EU-approved Humalog.

Conditions: Type 1 Diabetes
Being tested: Administration of BioChaperone insulin lispro reconstituted with Humalog® (IMP1), Administration of Ready-to-use BioChaperone insulin lispro (IMP2), Administration of US-approved Humalog® (IMP3), Administration of EU-approved Humalog® (IMP4)
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.

Administration of BioChaperone insulin lispro reconstituted with Humalog® (IMP1)Drug
Administration of IMP1 during a 12-hour euglycaemic clamp.
Administration of Ready-to-use BioChaperone insulin lispro (IMP2)Drug
Administration of IMP2 during a 12-hour euglycaemic clamp.
Administration of US-approved Humalog® (IMP3)Drug
Administration of IMP3 during a 12-hour euglycaemic clamp.
Administration of EU-approved Humalog® (IMP4)Drug
Administration of IMP4 during a 12-hour euglycaemic clamp.

Study groups in NCT04501107
Study group	Role	What they receive
BioChaperone insulin lispro reconstituted with Humalog® (IMP1)	Experimental	Subcutaneous administration of Biochaperone insulin lispro formulation made from a freeze-dried of BioChaperone reconstituted with Humalog® at a dose of 0.2 U/Kg Body Weight (BW). Receives: Drug: Administration of BioChaperone insulin lispro reconstituted with Humalog® (IMP1)
Ready-to-use BioChaperone insulin lispro (IMP2)	Experimental	Subcutaneous administration of ready-to-use Biochaperone insulin lispro formulation at a dose of 0.2 U/Kg BW. Receives: Drug: Administration of Ready-to-use BioChaperone insulin lispro (IMP2)
US-approved Humalog® (IMP3)	Active comparator	Subcutaneous administration of US-approved Humalog® at a dose of 0.2 U/Kg BW. Receives: Drug: Administration of US-approved Humalog® (IMP3)
EU-approved Humalog® (IMP4)	Active comparator	Subcutaneous administration of EU-approved Humalog® at a dose of 0.2 U/Kg BW. Receives: Drug: Administration of EU-approved Humalog® (IMP4)

What is being measured

The primary outcome is the main question the study is designed to answer.

AUCGIR.0-12h
Area under the glucose infusion rate-time curve from time 0 until end of clamp
Measured: From t=0 to t=12 hours after IMP administration
AUCGIR.0-1h
Area under the glucose infusion rate-time curve from time 0 to 1 hour after IMP administration
Measured: From t=0 to t=1 hour after IMP administration
AUCLIS.0-12h
Area under the insulin lispro concentration-time curve from 0 hours to 12 hours after dose administration
Measured: From t=0 to t=12 hours after IMP administration
AUCLIS.0-1h
Area under the insulin lispro concentration-time curve from 0 hours to 1 hour after dose administration
Measured: From t=0 to t=1 hour after IMP administration

Secondary outcomes (7)

tmax.LIS
Time to maximum observed insulin lispro concentration
Measured: From t=0 to t=12 hours after IMP administration
Cmax.LIS
Maximum observed insulin lispro concentration
Measured: From t=0 to t=12 hours after IMP administration
AUCLIS.2-6h
Area under the insulin lispro concentration-time curve from 2 hour to 6 hour after dose administration
Measured: From t=2 to t=6hours after IMP administration
t50%-LIS (early)
Time to half-maximum before Cmax.LIS
Measured: From t=0 to t=12 hours after IMP administration
tmax.GIR
Time to maximum glucose infusion rate
Measured: From t=0 to t=12 hours after IMP administration
GIRmax
Maximum glucose infusion rate
Measured: From t=0 to t=12 hours after IMP administration
AUCGIR.4-8h
Area under the glucose infusion rate-time curve from 4 to 8 hours after dose administration
Measured: From t=4 to t=8 hours after IMP administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Aug 20203 Nov 2020

First posted6 Aug 2020
Study start3 Aug 2020
Primary completion3 Nov 2020
Study completion3 Nov 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Type 1 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04501107
Sponsor's protocol ID: CT037-ADO02
Status last verified: Nov 2020
First submitted: 3 Aug 2020
Last updated: 30 Nov 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 30 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Double Blind, Crossover Euglycaemic Clamp Trial to Compare BioChaperone Insulin Lispro Formulations With US Approved Humalog® and With EU Approved Humalog® in Patients With Type 1 Diabetes Mellitus
ClinicalTrials.gov ID: NCT04501107
Acronym / sponsor ID: CT037-ADO02
Conditions: Type 1 Diabetes
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: AdociaIndustry (pharma, biotech, devices)
Study start: 3 Aug 2020 (actual)
Primary completion: 3 Nov 2020 (actual)
Study completion: 3 Nov 2020 (actual)
First posted: 6 Aug 2020 (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.

The trial will compare the characteristics of BioChaperone insulin lispro fully liquid (IMP2) formulation to US-approved Humalog and EU-approved Humalog.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
BioChaperone insulin lispro reconstituted with Humalog® (IMP1)	Experimental	Drug: Administration of BioChaperone insulin lispro reconstituted with Humalog® (IMP1)Subcutaneous administration of Biochaperone insulin lispro formulation made from a freeze-dried of BioChaperone reconstituted with Humalog® at a dose of 0.2 U/Kg Body Weight (BW).
Ready-to-use BioChaperone insulin lispro (IMP2)	Experimental	Drug: Administration of Ready-to-use BioChaperone insulin lispro (IMP2)Subcutaneous administration of ready-to-use Biochaperone insulin lispro formulation at a dose of 0.2 U/Kg BW.
US-approved Humalog® (IMP3)	Active comparator	Drug: Administration of US-approved Humalog® (IMP3)Subcutaneous administration of US-approved Humalog® at a dose of 0.2 U/Kg BW.
EU-approved Humalog® (IMP4)	Active comparator	Drug: Administration of EU-approved Humalog® (IMP4)Subcutaneous administration of EU-approved Humalog® at a dose of 0.2 U/Kg BW.

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Subjects with type 1 Diabetes Mellitus
Body Mass Index (BMI) between 18.5 and 28.5 kg/m^2, both inclusive
HbA1c <= 75 mmol/mol (<=9.0%).
Fasting negative C-peptide (<= 0.30 nmol/L).
Total insulin dose of < 1.2 (I)U/kg/day.

Key exclusion criteria (10 listed)

Known or suspected hypersensitivity to IMP(s) or related products.
Receipt of any medicinal product in clinical development within 30 days or at least 5 half-lives of the related substances and their metabolites (whichever is longer) before randomisation in this trial.
History of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction.
Any history or presence of cancer except basal cell skin cancer or squamous cell skin cancer as judged by the Investigator.
Any history or presence of clinically relevant comorbidity capable of constituting a risk for the subject when participating in the trial or of interfering with the interpretation of data.

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
Administration of BioChaperone insulin lispro reconstituted with Humalog® (IMP1)Administration of IMP1 during a 12-hour euglycaemic clamp.	Drug	BioChaperone insulin lispro reconstituted with Humalog® (IMP1)
Administration of Ready-to-use BioChaperone insulin lispro (IMP2)Administration of IMP2 during a 12-hour euglycaemic clamp.	Drug	Ready-to-use BioChaperone insulin lispro (IMP2)
Administration of US-approved Humalog® (IMP3)Administration of IMP3 during a 12-hour euglycaemic clamp.	Drug	US-approved Humalog® (IMP3)
Administration of EU-approved Humalog® (IMP4)Administration of IMP4 during a 12-hour euglycaemic clamp.	Drug	EU-approved Humalog® (IMP4)

Primary outcome

AUCGIR.0-12h
Time frame: From t=0 to t=12 hours after IMP administration
Area under the glucose infusion rate-time curve from time 0 until end of clamp
AUCGIR.0-1h
Time frame: From t=0 to t=1 hour after IMP administration
Area under the glucose infusion rate-time curve from time 0 to 1 hour after IMP administration
AUCLIS.0-12h
Time frame: From t=0 to t=12 hours after IMP administration
Area under the insulin lispro concentration-time curve from 0 hours to 12 hours after dose administration
AUCLIS.0-1h
Time frame: From t=0 to t=1 hour after IMP administration
Area under the insulin lispro concentration-time curve from 0 hours to 1 hour after dose administration

7 secondary outcomes

tmax.LIS
Time frame: From t=0 to t=12 hours after IMP administration
Cmax.LIS
Time frame: From t=0 to t=12 hours after IMP administration
AUCLIS.2-6h
Time frame: From t=2 to t=6hours after IMP administration
t50%-LIS (early)
Time frame: From t=0 to t=12 hours after IMP administration
tmax.GIR
Time frame: From t=0 to t=12 hours after IMP administration
GIRmax
Time frame: From t=0 to t=12 hours after IMP administration
AUCGIR.4-8h
Time frame: From t=4 to t=8 hours after IMP administration

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 30 Nov 2020.

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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.

Eugen Baumgaertner, 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?

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 6 inclusion and 10 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 30 Nov 2020. 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.0-12h (time frame: From t=0 to t=12 hours after IMP administration). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04501107.

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 30 Nov 2020.