Comparision of Pharmacokinetic and Pharmacodynamic of Biocon Insulin N and Humulin® N

January 29, 2020 updated by: Biocon Limited

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Neuss, Germany
        • Profil Institut für Stoffwechselforschung GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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).
  2. Age between 18 and 55 years, both inclusive
  3. Body mass index between 18.5 and 29.0 kg/m^2, both inclusive.
  4. Fasting plasma glucose concentration <= 100 mg/dl.
  5. Considered generally healthy upon completion of medical history and screening safety assessments, as judged by the Investigator.

Exclusion Criteria:

  1. Known or suspected hypersensitivity to Investigational Medicinal products (IMP(s)) or related products.
  2. 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).
  3. Pulse rate at rest outside the range of 50-90 beats per minute.
  4. Receipt of any medicinal product in clinical development within 30 days or five times its half-life (whichever is longer) before randomisation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Primary PK endpoint: area under the insulin concentration curve(AUCins).0-24h
Time Frame: 0-24hour
area under the insulin concentration curve
0-24hour
Primary PK endpoint: maximum observed insulin concentration(Cins.max)
Time Frame: 0-24hour
maximum observed insulin concentration
0-24hour
PD endpoint:area under the glucose infusion rate curve(AUCGIR)0-24h
Time Frame: 0-24hour
area under the glucose infusion rate curve
0-24hour
PD endpoint:maximum observed glucose infusion rate (GIRmax)
Time Frame: 0-24hour
maximum observed glucose infusion rate
0-24hour

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
0-24 hours
Secondary PK endpoint: area under the insulin concentration-time curve(AUCins).0-12h
Time Frame: 0-12hour
area under the insulin concentration-time curve
0-12hour
Secondary PK endpoint: area under the insulin concentration-time curve(AUCins).12-24h
Time Frame: 12-24hour
area under the insulin concentration-time curve
12-24hour
Secondary PK endpoint:time to maximum observed insulin concentration (tmax.ins)
Time Frame: 0-24 hours
time to maximum observed insulin concentration
0-24 hours
Secondary PK endpoint:terminal elimination rate constant of insulin (λz)
Time Frame: 0-24 hours
terminal elimination rate constant of insulin
0-24 hours
Secondary PK endpoint: terminal elimination half-life (t½)
Time Frame: 0-24 hours
terminal elimination half-life calculated as t½=ln2/λz
0-24 hours
Secondary PK endpoint: time(t)50%-INS(early)
Time Frame: 0-24 hours
time to half-maximum before Cmax
0-24 hours
Secondary PK endpoint: time(t)50%-INS(late)
Time Frame: 0-24 hours
time to half-maximum after Cmax
0-24 hours
Secondary PD endpoint: areas under the glucose infusion rate curve(AUCGIR).0-12h
Time Frame: 0-12hours
areas under the glucose infusion rate curve
0-12hours
Secondary PD endpoint: areas under the glucose infusion rate curve(AUCGIR).12-24h
Time Frame: 12-24hours
areas under the glucose infusion rate curve
12-24hours
Secondary PD endpoint: time to maximum glucose infusion rate(tmax.GIR)
Time Frame: 0-24 hours
time to maximum glucose infusion rate
0-24 hours
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
0-24 hours
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
0-24 hours
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))
0-24 hours

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
First dose to followup period (Total duration: 21 days approximate)
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)
Screening and Follow-up period (Total duration: 42 days approximate)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biocon Limited

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Profil Institut für Stoffwechselforschung GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dr. Grit Andersen, Profil Institut für Stoffwechselforschung GmbH Hellersbergstraße 9]

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 15, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 21, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 27, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 29, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 17, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 30, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EQN

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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