Back to resultsA Trial to Compare BioChaperone Insulin Lispro Formulations With US Approved Humalog® and With EU Approved Humalog® in Patients With Type 1 Diabetes Mellitus
Primary Purpose
Type 1 Diabetes
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
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)
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
- Profil GmbH
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Active Comparator
Arm Label
BioChaperone insulin lispro reconstituted with Humalog® (IMP1)
Ready-to-use BioChaperone insulin lispro (IMP2)
US-approved Humalog® (IMP3)
EU-approved Humalog® (IMP4)
Arm Description
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).
Subcutaneous administration of ready-to-use Biochaperone insulin lispro formulation at a dose of 0.2 U/Kg BW.
Subcutaneous administration of US-approved Humalog® at a dose of 0.2 U/Kg BW.
Subcutaneous administration of EU-approved Humalog® at a dose of 0.2 U/Kg BW.
Outcomes
Primary Outcome Measures
AUCGIR.0-12h
Area under the glucose infusion rate-time curve from time 0 until end of clamp
AUCGIR.0-1h
Area under the glucose infusion rate-time curve from time 0 to 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
AUCLIS.0-1h
Area under the insulin lispro concentration-time curve from 0 hours to 1 hour after dose administration
Secondary Outcome Measures
tmax.LIS
Time to maximum observed insulin lispro concentration
Cmax.LIS
Maximum observed insulin lispro concentration
AUCLIS.2-6h
Area under the insulin lispro concentration-time curve from 2 hour to 6 hour after dose administration
t50%-LIS (early)
Time to half-maximum before Cmax.LIS
tmax.GIR
Time to maximum glucose infusion rate
GIRmax
Maximum glucose infusion rate
AUCGIR.4-8h
Area under the glucose infusion rate-time curve from 4 to 8 hours after dose administration
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04501107
Brief Title
A Trial to Compare BioChaperone Insulin Lispro Formulations With US Approved Humalog® and With EU Approved Humalog® in Patients With Type 1 Diabetes Mellitus
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
August 3, 2020 (Actual)
Primary Completion Date
November 3, 2020 (Actual)
Study Completion Date
November 3, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Adocia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BioChaperone insulin lispro reconstituted with Humalog® (IMP1)
Arm Type
Experimental
Arm Description
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).
Arm Title
Ready-to-use BioChaperone insulin lispro (IMP2)
Arm Type
Experimental
Arm Description
Subcutaneous administration of ready-to-use Biochaperone insulin lispro formulation at a dose of 0.2 U/Kg BW.
Arm Title
US-approved Humalog® (IMP3)
Arm Type
Active Comparator
Arm Description
Subcutaneous administration of US-approved Humalog® at a dose of 0.2 U/Kg BW.
Arm Title
EU-approved Humalog® (IMP4)
Arm Type
Active Comparator
Arm Description
Subcutaneous administration of EU-approved Humalog® at a dose of 0.2 U/Kg BW.
Intervention Type
Drug
Intervention Name(s)
Administration of BioChaperone insulin lispro reconstituted with Humalog® (IMP1)
Intervention Description
Administration of IMP1 during a 12-hour euglycaemic clamp.
Intervention Type
Drug
Intervention Name(s)
Administration of Ready-to-use BioChaperone insulin lispro (IMP2)
Intervention Description
Administration of IMP2 during a 12-hour euglycaemic clamp.
Intervention Type
Drug
Intervention Name(s)
Administration of US-approved Humalog® (IMP3)
Intervention Description
Administration of IMP3 during a 12-hour euglycaemic clamp.
Intervention Type
Drug
Intervention Name(s)
Administration of EU-approved Humalog® (IMP4)
Intervention Description
Administration of IMP4 during a 12-hour euglycaemic clamp.
Primary Outcome Measure Information:
Title
AUCGIR.0-12h
Description
Area under the glucose infusion rate-time curve from time 0 until end of clamp
Time Frame
From t=0 to t=12 hours after IMP administration
Title
AUCGIR.0-1h
Description
Area under the glucose infusion rate-time curve from time 0 to 1 hour after IMP administration
Time Frame
From t=0 to t=1 hour after IMP administration
Title
AUCLIS.0-12h
Description
Area under the insulin lispro concentration-time curve from 0 hours to 12 hours after dose administration
Time Frame
From t=0 to t=12 hours after IMP administration
Title
AUCLIS.0-1h
Description
Area under the insulin lispro concentration-time curve from 0 hours to 1 hour after dose administration
Time Frame
From t=0 to t=1 hour after IMP administration
Secondary Outcome Measure Information:
Title
tmax.LIS
Description
Time to maximum observed insulin lispro concentration
Time Frame
From t=0 to t=12 hours after IMP administration
Title
Cmax.LIS
Description
Maximum observed insulin lispro concentration
Time Frame
From t=0 to t=12 hours after IMP administration
Title
AUCLIS.2-6h
Description
Area under the insulin lispro concentration-time curve from 2 hour to 6 hour after dose administration
Time Frame
From t=2 to t=6hours after IMP administration
Title
t50%-LIS (early)
Description
Time to half-maximum before Cmax.LIS
Time Frame
From t=0 to t=12 hours after IMP administration
Title
tmax.GIR
Description
Time to maximum glucose infusion rate
Time Frame
From t=0 to t=12 hours after IMP administration
Title
GIRmax
Description
Maximum glucose infusion rate
Time Frame
From t=0 to t=12 hours after IMP administration
Title
AUCGIR.4-8h
Description
Area under the glucose infusion rate-time curve from 4 to 8 hours after dose administration
Time Frame
From t=4 to t=8 hours after IMP administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eugen Baumgaertner, MD
Organizational Affiliation
Profil GmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Profil GmbH
City
Mainz
ZIP/Postal Code
D-55116
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
A Trial to Compare BioChaperone Insulin Lispro Formulations With US Approved Humalog® and With EU Approved Humalog® in Patients With Type 1 Diabetes Mellitus
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