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Completed

NCT Number: NCT04022304

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

Single-centre, randomised, double-blind, three-period, six-sequence, partially replicated design, crossover trial in healthy subjects

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Key information

Conditions

Healthy Volunteer

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Profil Institut für Stoffwechselforschung GmbH

Neuss, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biocon Insulin N

Biological

Biocon Insulin N is an intermediate-acting isophane suspension of human insulin produced by recombinant deoxyribonucleic acid(rDNA) technology utilizing Pichia pastoris (yeast).

Humulin® N

Biological

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.

Primary outcomes

  1. Primary PK endpoint: area under the insulin concentration curve(AUCins).0-24h

    Time frame: 0-24hour

    area under the insulin concentration curve

  2. Primary PK endpoint: maximum observed insulin concentration(Cins.max)

    Time frame: 0-24hour

    maximum observed insulin concentration

  3. PD endpoint:area under the glucose infusion rate curve(AUCGIR)0-24h

    Time frame: 0-24hour

    area under the glucose infusion rate curve

  4. PD endpoint:maximum observed glucose infusion rate (GIRmax)

    Time frame: 0-24hour

    maximum observed glucose infusion rate

Secondary outcomes

  1. 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

  2. Secondary PK endpoint: area under the insulin concentration-time curve(AUCins).0-12h

    Time frame: 0-12hour

    area under the insulin concentration-time curve

  3. Secondary PK endpoint: area under the insulin concentration-time curve(AUCins).12-24h

    Time frame: 12-24hour

    area under the insulin concentration-time curve

  4. Secondary PK endpoint:time to maximum observed insulin concentration (tmax.ins)

    Time frame: 0-24 hours

    time to maximum observed insulin concentration

  5. Secondary PK endpoint:terminal elimination rate constant of insulin (λz)

    Time frame: 0-24 hours

    terminal elimination rate constant of insulin

  6. Secondary PK endpoint: terminal elimination half-life (t½)

    Time frame: 0-24 hours

    terminal elimination half-life calculated as t½=ln2/λz

  7. Secondary PK endpoint: time(t)50%-INS(early)

    Time frame: 0-24 hours

    time to half-maximum before Cmax

  8. Secondary PK endpoint: time(t)50%-INS(late)

    Time frame: 0-24 hours

    time to half-maximum after Cmax

  9. Secondary PD endpoint: areas under the glucose infusion rate curve(AUCGIR).0-12h

    Time frame: 0-12hours

    areas under the glucose infusion rate curve

  10. Secondary PD endpoint: areas under the glucose infusion rate curve(AUCGIR).12-24h

    Time frame: 12-24hours

    areas under the glucose infusion rate curve

  11. Secondary PD endpoint: time to maximum glucose infusion rate(tmax.GIR)

    Time frame: 0-24 hours

    time to maximum glucose infusion rate

  12. 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

  13. 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

  14. 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))

Other outcomes

  1. 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

  2. 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)

Sponsors and collaborators

Lead sponsor

Biocon Limited

Industry

Collaborators

  • Profil Institut für Stoffwechselforschung GmbH

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 17, 2019
Registry last updated
Jan 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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