Healthy VolunteerPhase 1NCT04022304
Comparision of Pharmacokinetic and Pharmacodynamic of Biocon Insulin N and Humulin® N
A Phase 1 study testing Biocon Insulin N and Humulin® N in people with Healthy Volunteer, run by Biocon Limited at 1 site in Germany.
Trial summary
Single-centre, randomised, double-blind, three-period, six-sequence, partially replicated design, crossover trial in healthy subjects Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Biocon Insulin N and Humulin® N
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteGermany
- Study dates
- 15 Jun 2019to 27 Dec 2019
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and post-menopausal female subjects. Post-menopausal defined as 12 months of no menses without an alternative medical cause and confirmed by a follicle stimulating hormone (FSH) level in the post-menopausal range (>= 25.8 IU/L).
- Age between 18 and 55 years, both inclusive
- Body mass index between 18.5 and 29.0 kg/m^2, both inclusive.
- Fasting plasma glucose concentration <= 100 mg/dl.
- Considered generally healthy upon completion of medical history and screening safety assessments, as judged by the Investigator.
Who cannot join
- Known or suspected hypersensitivity to Investigational Medicinal products (IMP(s)) or related products.
- Systolic blood pressure < 95 mmHg or >140 mmHg and/or diastolic blood pressure < 50 mm Hg or >90 mmHg after resting for at least 5 minutes in supine position (excluding white-coat hypertension; therefore, a repeat test showing results within range will be acceptable).
- Pulse rate at rest outside the range of 50-90 beats per minute.
- Receipt of any medicinal product in clinical development within 30 days or five times its half-life (whichever is longer) before randomisation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-blind, Three-period, Partially Replicated Crossover, Euglycaemic Glucose Clamp Study in Healthy Volunteers to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity of Biocon Insulin N and Humulin® N
Single-centre, randomised, double-blind, three-period, six-sequence, partially replicated design, crossover trial in healthy subjects
Read the detailed description
The present study is designed to demonstrate pharmacokinetic and pharmacodynamic equivalence of Biocon Insulin N with Humulin® N in healthy subjects.
The treatment consists of one single dose of the test or reference product, administered during each of the three study periods, separated by 5-7 days between each dosing. The planned trial duration for each subject is about 17 to 43 days. Eligible subjects will undergo three euglycaemic clamp examinations (each of 24 hours duration).
Depending on the sequence in which a particular subject is randomized, each subject will either undergo two clamps with administration of test product plus one clamp with administration of reference product, or, two clamps with administration of reference product plus one clamp with administration of test product, in random order.
- Conditions
- Healthy Volunteer
- Being tested
- Biocon Insulin N, Humulin® N
- Keywords
- Recombinant Human Insulin N (rhi N)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biocon Insulin NBiological
Biocon Insulin N is an intermediate-acting isophane suspension of human insulin produced by recombinant deoxyribonucleic acid(rDNA) technology utilizing Pichia pastoris (yeast).
Humulin® NBiological
Humulin® N (human insulin [recombinant deoxyribonucleic acid origin] isophane suspension) is an intermediate-acting human isophane insulin. Humulin® N is a suspension of crystals produced from combining human insulin and protamine sulphate.
| Study group | Role | What they receive |
|---|---|---|
| Sequence: Humulin® N- Biocon Insulin N-Humulin® N | Experimental | Period 1: 0.4 IU/kg of Humulin® N (100 IU/mL) administered once subcutaneously.
Period 2: 0.4 IU/kg of Biocon Insulin N (100 IU/mL) administered once subcutaneously.
Period 3: 0.4 IU/kg of Humulin® N (100 IU/mL) administered once subcutaneously.
The treatment periods will be separated by 5-7 days Receives: Biological: Biocon Insulin N; Biological: Humulin® N |
| Sequence: Biocon Insulin N- Humulin® N- Humulin® N | Experimental | Period 1: 0.4 IU/kg of Biocon Insulin N (100 IU/mL) administered once subcutaneously.
Period 2: 0.4 IU/kg of Humulin® N(100 IU/mL) administered once subcutaneously.
Period 3: 0.4 IU/kg of Humulin® N (100 IU/mL) administered once subcutaneously.
The treatment periods will be separated by 5-7 days Receives: Biological: Biocon Insulin N; Biological: Humulin® N |
| Sequence: Humulin® N- Humulin® N-Biocon Insulin N | Experimental | Period 1: 0.4 IU/kg of Humulin® N(100 IU/mL) administered once subcutaneously.
Period 2: 0.4 IU/kg of Humulin® N (100 IU/mL) administered once subcutaneously.
Period 3: 0.4 IU/kg of Biocon Insulin N (100 IU/mL) administered once subcutaneously.
The treatment periods will be separated by 5-7 days Receives: Biological: Biocon Insulin N; Biological: Humulin® N |
| Sequence: Biocon Insulin N- Humulin® N- Biocon Insulin N | Experimental | Period 1: 0.4 IU/kg of Biocon Insulin N (100 IU/mL) administered once subcutaneously.
Period 2: 0.4 IU/kg of Humulin® N (100 IU/mL) administered once subcutaneously.
Period 3: 0.4 IU/kg of Biocon Insulin N (100 IU/mL) administered once subcutaneously.
The treatment periods will be separated by 5-7 days Receives: Biological: Biocon Insulin N; Biological: Humulin® N |
| Sequence: Humulin® N-Biocon Insulin N- Biocon Insulin N | Experimental | Period 1: 0.4 IU/kg of Humulin® N (100 IU/mL) administered once subcutaneously.
Period 2: 0.4 IU/kg of Biocon Insulin N (100 IU/mL) administered once subcutaneously.
Period 3: 0.4 IU/kg of Biocon Insulin N (100 IU/mL) administered once subcutaneously.
The treatment periods will be separated by 5-7 days Receives: Biological: Biocon Insulin N; Biological: Humulin® N |
| Sequence: Biocon Insulin N- Biocon Insulin N-Humulin® N | Experimental | Period 1: 0.4 IU/kg of Biocon Insulin N (100 IU/mL) administered once subcutaneously.
Period 2: 0.4 IU/kg of Biocon Insulin N (100 IU/mL) administered once subcutaneously.
Period 3: 0.4 IU/kg of Humulin® N (100 IU/mL) administered once subcutaneously.
The treatment periods will be separated by 5-7 days Receives: Biological: Biocon Insulin N; Biological: Humulin® N |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary PK endpoint: area under the insulin concentration curve(AUCins).0-24h
area under the insulin concentration curve
Measured: 0-24hour
Primary PK endpoint: maximum observed insulin concentration(Cins.max)
maximum observed insulin concentration
Measured: 0-24hour
PD endpoint:area under the glucose infusion rate curve(AUCGIR)0-24h
area under the glucose infusion rate curve
Measured: 0-24hour
PD endpoint:maximum observed glucose infusion rate (GIRmax)
maximum observed glucose infusion rate
Measured: 0-24hour
Secondary outcomes (14)
Secondary PK endpoint: area under the insulin concentration-time curve(AUCins).0-infinity
area under the insulin concentration-time curve
Measured: 0-24 hours
Secondary PK endpoint: area under the insulin concentration-time curve(AUCins).0-12h
area under the insulin concentration-time curve
Measured: 0-12hour
Secondary PK endpoint: area under the insulin concentration-time curve(AUCins).12-24h
area under the insulin concentration-time curve
Measured: 12-24hour
Secondary PK endpoint:time to maximum observed insulin concentration (tmax.ins)
time to maximum observed insulin concentration
Measured: 0-24 hours
Secondary PK endpoint:terminal elimination rate constant of insulin (λz)
terminal elimination rate constant of insulin
Measured: 0-24 hours
Secondary PK endpoint: terminal elimination half-life (t½)
terminal elimination half-life calculated as t½=ln2/λz
Measured: 0-24 hours
Secondary PK endpoint: time(t)50%-INS(early)
time to half-maximum before Cmax
Measured: 0-24 hours
Secondary PK endpoint: time(t)50%-INS(late)
time to half-maximum after Cmax
Measured: 0-24 hours
Secondary PD endpoint: areas under the glucose infusion rate curve(AUCGIR).0-12h
areas under the glucose infusion rate curve
Measured: 0-12hours
Secondary PD endpoint: areas under the glucose infusion rate curve(AUCGIR).12-24h
areas under the glucose infusion rate curve
Measured: 12-24hours
Secondary PD endpoint: time to maximum glucose infusion rate(tmax.GIR)
time to maximum glucose infusion rate
Measured: 0-24 hours
Secondary PD endpoint:time to half-maximum glucose infusion rate before GIRmax (tGIR.50%-early)
time to half-maximum glucose infusion rate before GIRmax
Measured: 0-24 hours
Secondary PD endpoint: time to half-maximum glucose infusion rate after GIRmax (tGIR.50%-late)
time to half-maximum glucose infusion rate after GIRmax
Measured: 0-24 hours
Secondary PD endpoint: Onset of action
time from trial product administration until blood glucose concentration has decreased at least 5 mg/dL from baseline, where baseline is defined as the mean of blood glucose levels from -6, -4, and -2 minutes before trial product administration as measured by ClampArt(name of Clamp Devise))
Measured: 0-24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start15 Jun 2019
- Primary completion21 Dec 2019
- Study completion27 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Partially replicated design, crossover trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biocon Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Profil Institut für Stoffwechselforschung GmbH
- Responsible party
- Sponsor
- Investigators
- Dr. Grit Andersen, Principal investigator, Profil Institut für Stoffwechselforschung GmbH Hellersbergstraße 9]
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04022304
- Sponsor's protocol ID
- EQN
- Status last verified
- Jan 2020
- First submitted
- 29 Jun 2019
- Last updated
- 30 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Three-period, Partially Replicated Crossover, Euglycaemic Glucose Clamp Study in Healthy Volunteers to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity of Biocon Insulin N and Humulin® N
- ClinicalTrials.gov ID
- NCT04022304
- Acronym / sponsor ID
- EQN
- Conditions
- Healthy Volunteer
- Keywords
- Recombinant Human Insulin N (rhi N)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Biocon LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Profil Institut für Stoffwechselforschung GmbH
- Study start
- 15 Jun 2019 (actual)
- Primary completion
- 21 Dec 2019 (actual)
- Study completion
- 27 Dec 2019 (actual)
- First posted
- 17 Jul 2019 (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.
Single-centre, randomised, double-blind, three-period, six-sequence, partially replicated design, crossover trial in healthy subjects
Detailed description
The present study is designed to demonstrate pharmacokinetic and pharmacodynamic equivalence of Biocon Insulin N with Humulin® N in healthy subjects.
The treatment consists of one single dose of the test or reference product, administered during each of the three study periods, separated by 5-7 days between each dosing. The planned trial duration for each subject is about 17 to 43 days. Eligible subjects will undergo three euglycaemic clamp examinations (each of 24 hours duration).
Depending on the sequence in which a particular subject is randomized, each subject will either undergo two clamps with administration of test product plus one clamp with administration of reference product, or, two clamps with administration of reference product plus one clamp with administration of test product, in random order.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
- Model description
- Partially replicated design, crossover trial
| Arm | Type | Receives |
|---|---|---|
| Sequence: Humulin® N- Biocon Insulin N-Humulin® N | Experimental | Biological: Biocon Insulin N, Biological: Humulin® NPeriod 1: 0.4 IU/kg of Humulin® N (100 IU/mL) administered once subcutaneously. Period 2: 0.4 IU/kg of Biocon Insulin N (100 IU/mL) administered once subcutaneously. Period 3: 0.4 IU/kg of Humulin® N (100 IU/mL) administered once subcutaneously. The treatment periods will be separated by 5-7 days |
| Sequence: Biocon Insulin N- Humulin® N- Humulin® N | Experimental | Biological: Biocon Insulin N, Biological: Humulin® NPeriod 1: 0.4 IU/kg of Biocon Insulin N (100 IU/mL) administered once subcutaneously. Period 2: 0.4 IU/kg of Humulin® N(100 IU/mL) administered once subcutaneously. Period 3: 0.4 IU/kg of Humulin® N (100 IU/mL) administered once subcutaneously. The treatment periods will be separated by 5-7 days |
| Sequence: Humulin® N- Humulin® N-Biocon Insulin N | Experimental | Biological: Biocon Insulin N, Biological: Humulin® NPeriod 1: 0.4 IU/kg of Humulin® N(100 IU/mL) administered once subcutaneously. Period 2: 0.4 IU/kg of Humulin® N (100 IU/mL) administered once subcutaneously. Period 3: 0.4 IU/kg of Biocon Insulin N (100 IU/mL) administered once subcutaneously. The treatment periods will be separated by 5-7 days |
| Sequence: Biocon Insulin N- Humulin® N- Biocon Insulin N | Experimental | Biological: Biocon Insulin N, Biological: Humulin® NPeriod 1: 0.4 IU/kg of Biocon Insulin N (100 IU/mL) administered once subcutaneously. Period 2: 0.4 IU/kg of Humulin® N (100 IU/mL) administered once subcutaneously. Period 3: 0.4 IU/kg of Biocon Insulin N (100 IU/mL) administered once subcutaneously. The treatment periods will be separated by 5-7 days |
| Sequence: Humulin® N-Biocon Insulin N- Biocon Insulin N | Experimental | Biological: Biocon Insulin N, Biological: Humulin® NPeriod 1: 0.4 IU/kg of Humulin® N (100 IU/mL) administered once subcutaneously. Period 2: 0.4 IU/kg of Biocon Insulin N (100 IU/mL) administered once subcutaneously. Period 3: 0.4 IU/kg of Biocon Insulin N (100 IU/mL) administered once subcutaneously. The treatment periods will be separated by 5-7 days |
| Sequence: Biocon Insulin N- Biocon Insulin N-Humulin® N | Experimental | Biological: Biocon Insulin N, Biological: Humulin® NPeriod 1: 0.4 IU/kg of Biocon Insulin N (100 IU/mL) administered once subcutaneously. Period 2: 0.4 IU/kg of Biocon Insulin N (100 IU/mL) administered once subcutaneously. Period 3: 0.4 IU/kg of Humulin® N (100 IU/mL) administered once subcutaneously. The treatment periods will be separated by 5-7 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male and post-menopausal female subjects. Post-menopausal defined as 12 months of no menses without an alternative medical cause and confirmed by a follicle stimulating hormone (FSH) level in the post-menopausal range (>= 25.8 IU/L).
- Age between 18 and 55 years, both inclusive
- Body mass index between 18.5 and 29.0 kg/m^2, both inclusive.
- Fasting plasma glucose concentration <= 100 mg/dl.
- Considered generally healthy upon completion of medical history and screening safety assessments, as judged by the Investigator.
Key exclusion criteria (4 listed)
- Known or suspected hypersensitivity to Investigational Medicinal products (IMP(s)) or related products.
- Systolic blood pressure < 95 mmHg or >140 mmHg and/or diastolic blood pressure < 50 mm Hg or >90 mmHg after resting for at least 5 minutes in supine position (excluding white-coat hypertension; therefore, a repeat test showing results within range will be acceptable).
- Pulse rate at rest outside the range of 50-90 beats per minute.
- Receipt of any medicinal product in clinical development within 30 days or five times its half-life (whichever is longer) before randomisation.
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 |
|---|---|---|
| Biocon Insulin NBiocon Insulin N is an intermediate-acting isophane suspension of human insulin produced by recombinant deoxyribonucleic acid(rDNA) technology utilizing Pichia pastoris (yeast). | Biological | Sequence: Biocon Insulin N- Biocon Insulin N-Humulin® N, Sequence: Biocon Insulin N- Humulin® N- Biocon Insulin N, Sequence: Biocon Insulin N- Humulin® N- Humulin® N, Sequence: Humulin® N- Biocon Insulin N-Humulin® N, Sequence: Humulin® N- Humulin® N-Biocon Insulin N, Sequence: Humulin® N-Biocon Insulin N- Biocon Insulin N |
| Humulin® NHumulin® N (human insulin [recombinant deoxyribonucleic acid origin] isophane suspension) is an intermediate-acting human isophane insulin. Humulin® N is a suspension of crystals produced from combining human insulin and protamine sulphate. | Biological | Sequence: Biocon Insulin N- Biocon Insulin N-Humulin® N, Sequence: Biocon Insulin N- Humulin® N- Biocon Insulin N, Sequence: Biocon Insulin N- Humulin® N- Humulin® N, Sequence: Humulin® N- Biocon Insulin N-Humulin® N, Sequence: Humulin® N- Humulin® N-Biocon Insulin N, Sequence: Humulin® N-Biocon Insulin N- Biocon Insulin N |
Primary outcome
Primary PK endpoint: area under the insulin concentration curve(AUCins).0-24h
Time frame: 0-24hour
area under the insulin concentration curve
Primary PK endpoint: maximum observed insulin concentration(Cins.max)
Time frame: 0-24hour
maximum observed insulin concentration
PD endpoint:area under the glucose infusion rate curve(AUCGIR)0-24h
Time frame: 0-24hour
area under the glucose infusion rate curve
PD endpoint:maximum observed glucose infusion rate (GIRmax)
Time frame: 0-24hour
maximum observed glucose infusion rate
14 secondary outcomes
Secondary PK endpoint: area under the insulin concentration-time curve(AUCins).0-infinity
Time frame: 0-24 hours
Secondary PK endpoint: area under the insulin concentration-time curve(AUCins).0-12h
Time frame: 0-12hour
Secondary PK endpoint: area under the insulin concentration-time curve(AUCins).12-24h
Time frame: 12-24hour
Secondary PK endpoint:time to maximum observed insulin concentration (tmax.ins)
Time frame: 0-24 hours
Secondary PK endpoint:terminal elimination rate constant of insulin (λz)
Time frame: 0-24 hours
Secondary PK endpoint: terminal elimination half-life (t½)
Time frame: 0-24 hours
Secondary PK endpoint: time(t)50%-INS(early)
Time frame: 0-24 hours
Secondary PK endpoint: time(t)50%-INS(late)
Time frame: 0-24 hours
Secondary PD endpoint: areas under the glucose infusion rate curve(AUCGIR).0-12h
Time frame: 0-12hours
Secondary PD endpoint: areas under the glucose infusion rate curve(AUCGIR).12-24h
Time frame: 12-24hours
Secondary PD endpoint: time to maximum glucose infusion rate(tmax.GIR)
Time frame: 0-24 hours
Secondary PD endpoint:time to half-maximum glucose infusion rate before GIRmax (tGIR.50%-early)
Time frame: 0-24 hours
Secondary PD endpoint: time to half-maximum glucose infusion rate after GIRmax (tGIR.50%-late)
Time frame: 0-24 hours
Secondary PD endpoint: Onset of action
Time frame: 0-24 hours
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 Jan 2020.
Related trials for Healthy Volunteer
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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.
Dr. Grit Andersen principal investigator
Profil Institut für Stoffwechselforschung GmbH Hellersbergstraße 9]
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 Biocon Insulin N and Humulin® N in people with Healthy Volunteer, run by Biocon Limited 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 5 inclusion and 4 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 Jan 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?
Primary PK endpoint: area under the insulin concentration curve(AUCins).0-24h (time frame: 0-24hour). 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?
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 Jan 2020.