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Comparision of Pharmacokinetic and Pharmacodynamic of Biocon Insulin N and Humulin® N
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Healthy Volunteer | Biological: Biocon Insulin N Biological: Humulin® N | Phase 1 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 90 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Partially replicated design, crossover trial |
| Masking: | Double (Participant, Investigator) |
| Masking Description: | Double blind study |
| Primary Purpose: | Other |
| 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 |
| Actual Study Start Date : | June 15, 2019 |
| Actual Primary Completion Date : | December 21, 2019 |
| Actual Study Completion Date : | December 27, 2019 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Sequence: Humulin® N- Biocon Insulin N-Humulin® N
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 |
Biological: Biocon Insulin N
Biocon Insulin N is an intermediate-acting isophane suspension of human insulin produced by recombinant deoxyribonucleic acid(rDNA) technology utilizing Pichia pastoris (yeast).
Biological: Humulin® N 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.
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Experimental: Sequence: Biocon Insulin N- Humulin® N- Humulin® N
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 |
Biological: Biocon Insulin N
Biocon Insulin N is an intermediate-acting isophane suspension of human insulin produced by recombinant deoxyribonucleic acid(rDNA) technology utilizing Pichia pastoris (yeast).
Biological: Humulin® N 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.
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|
Experimental: Sequence: Humulin® N- Humulin® N-Biocon Insulin N
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 |
Biological: Biocon Insulin N
Biocon Insulin N is an intermediate-acting isophane suspension of human insulin produced by recombinant deoxyribonucleic acid(rDNA) technology utilizing Pichia pastoris (yeast).
Biological: Humulin® N 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.
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|
Experimental: Sequence: Biocon Insulin N- Humulin® N- Biocon Insulin N
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 |
Biological: Biocon Insulin N
Biocon Insulin N is an intermediate-acting isophane suspension of human insulin produced by recombinant deoxyribonucleic acid(rDNA) technology utilizing Pichia pastoris (yeast).
Biological: Humulin® N 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.
|
|
Experimental: Sequence: Humulin® N-Biocon Insulin N- Biocon Insulin N
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 |
Biological: Biocon Insulin N
Biocon Insulin N is an intermediate-acting isophane suspension of human insulin produced by recombinant deoxyribonucleic acid(rDNA) technology utilizing Pichia pastoris (yeast).
Biological: Humulin® N 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.
|
|
Experimental: Sequence: Biocon Insulin N- Biocon Insulin N-Humulin® N
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 |
Biological: Biocon Insulin N
Biocon Insulin N is an intermediate-acting isophane suspension of human insulin produced by recombinant deoxyribonucleic acid(rDNA) technology utilizing Pichia pastoris (yeast).
Biological: Humulin® N 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.
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- 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
- Secondary PK endpoint: area under the insulin concentration-time curve(AUCins).0-infinity [ Time Frame: 0-24 hours ]area under the insulin concentration-time curve
- Secondary PK endpoint: area under the insulin concentration-time curve(AUCins).0-12h [ Time Frame: 0-12hour ]area under the insulin concentration-time curve
- Secondary PK endpoint: area under the insulin concentration-time curve(AUCins).12-24h [ Time Frame: 12-24hour ]area under the insulin concentration-time curve
- Secondary PK endpoint:time to maximum observed insulin concentration (tmax.ins) [ Time Frame: 0-24 hours ]time to maximum observed insulin concentration
- Secondary PK endpoint:terminal elimination rate constant of insulin (λz) [ Time Frame: 0-24 hours ]terminal elimination rate constant of insulin
- Secondary PK endpoint: terminal elimination half-life (t½) [ Time Frame: 0-24 hours ]terminal elimination half-life calculated as t½=ln2/λz
- Secondary PK endpoint: time(t)50%-INS(early) [ Time Frame: 0-24 hours ]time to half-maximum before Cmax
- Secondary PK endpoint: time(t)50%-INS(late) [ Time Frame: 0-24 hours ]time to half-maximum after Cmax
- Secondary PD endpoint: areas under the glucose infusion rate curve(AUCGIR).0-12h [ Time Frame: 0-12hours ]areas under the glucose infusion rate curve
- Secondary PD endpoint: areas under the glucose infusion rate curve(AUCGIR).12-24h [ Time Frame: 12-24hours ]areas under the glucose infusion rate curve
- Secondary PD endpoint: time to maximum glucose infusion rate(tmax.GIR) [ Time Frame: 0-24 hours ]time to maximum glucose infusion rate
- Secondary PD endpoint:time to half-maximum glucose infusion rate before GIRmax (tGIR.50%-early) [ Time Frame: 0-24 hours ]time to half-maximum glucose infusion rate before GIRmax
- Secondary PD endpoint: time to half-maximum glucose infusion rate after GIRmax (tGIR.50%-late) [ Time Frame: 0-24 hours ]time to half-maximum glucose infusion rate after GIRmax
- Secondary PD endpoint: Onset of action [ Time Frame: 0-24 hours ]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))
- Safety endpoint: Number of subjects with Adverse Events (AEs), clinically significant changes in Physical examination, Vital signs. Local tolerability/ Injection site reactions [ Time Frame: First dose to followup period (Total duration: 21 days approximate) ]
Number of subjects with Adverse Events (AEs), clinically significant changes in Physical examination, Vital signs.
Local tolerability/ Injection site reactions
- Safety endpoint: Number of subjects with clinically significant changes in Laboratory safety parameters, Electrocardiogram (ECG) [ Time Frame: Screening and Follow-up period (Total duration: 42 days approximate) ]
Number of subjects with clinically significant changes in Laboratory safety parameters.
Number of subjects with clinically significant changes in Electrocardiogram (ECG)
| Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
| Germany | |
| Profil Institut für Stoffwechselforschung GmbH | |
| Neuss, Germany | |
| Principal Investigator: | Dr. Grit Andersen | Profil Institut für Stoffwechselforschung GmbH Hellersbergstraße 9] |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 29, 2019 | ||||
| First Posted Date ICMJE | July 17, 2019 | ||||
| Last Update Posted Date | January 30, 2020 | ||||
| Actual Study Start Date ICMJE | June 15, 2019 | ||||
| Actual Primary Completion Date | December 21, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures |
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| Original Other Pre-specified Outcome Measures | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Comparision of Pharmacokinetic and Pharmacodynamic of Biocon Insulin N and Humulin® N | ||||
| Official Title ICMJE | 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 | ||||
| Brief Summary | 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 1 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Partially replicated design, crossover trial Masking: Double (Participant, Investigator)Masking Description: Double blind study Primary Purpose: Other
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| Condition ICMJE | Healthy Volunteer | ||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
90 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Actual Study Completion Date ICMJE | December 27, 2019 | ||||
| Actual Primary Completion Date | December 21, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 55 Years (Adult) | ||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Germany | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT04022304 | ||||
| Other Study ID Numbers ICMJE | EQN | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Biocon Limited | ||||
| Study Sponsor ICMJE | Biocon Limited | ||||
| Collaborators ICMJE | Profil Institut für Stoffwechselforschung GmbH | ||||
| Investigators ICMJE |
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| PRS Account | Biocon Limited | ||||
| Verification Date | January 2020 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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