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Comparision of Pharmacokinetics(PK) and Pharmacodynamics(PD) of Biocon Insulin R and Humulin® R

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ClinicalTrials.gov Identifier: NCT04022317
Recruitment Status : Recruiting
First Posted : July 17, 2019
Last Update Posted : July 17, 2019
Sponsor:
Collaborator:
Profil Institut für Stoffwechselforschung GmbH
Information provided by (Responsible Party):
Biocon Limited

Brief Summary:
Single-centre, randomised, double-blind, single dose, two-treatment, two-period, two sequence, crossover,12-hour euglycaemic glucose clamp trial in healthy subjects

Condition or disease Intervention/treatment Phase
Healthy Volunteer Biological: Biocon Insulin R Biological: Humulin®R Phase 1

Detailed Description:

The present study is designed to demonstrate pharmacokinetic and pharmacodynamic equivalence of Biocon Insulin R with Humulin® R in healthy subjects.

The treatment consists of one single dose of the test or reference product, administered during each of the two study periods, separated by 5-7 days between each dosing.

The planned trial duration for each subject is about 12 to 36 days. Eligible subjects will undergo two 12-hour euglycaemic clamp examinations, one after administration of the test product and one after administration of the reference product in random order.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double-blind
Primary Purpose: Other
Official Title: A Randomised, Double-blind, Two-period Crossover, Euglycaemic Glucose Clamp Study in Healthy Volunteers to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity of Biocon Insulin R and Humulin® R
Actual Study Start Date : June 18, 2019
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Biocon Insulin R
0.3 IU/kg Dose per administration, subcutaneous Route of administration
Biological: Biocon Insulin R
Biocon Insulin R is a short-acting human insulin, produced by recombinant deoxyribonucleic acid (rDNA) technology utilizing Pichia pastoris (yeast).

Active Comparator: Humulin® R (regular insulin human)
0.3 IU/kg Dose per administration, subcutaneous Route of administration
Biological: Humulin®R
Humulin® R is a polypeptide hormone structurally identical to human insulin synthesised through recombinant deoxyribonucleic acid (rDNA) technology in a non-pathogenic laboratory strain of Escherichia coli bacteria.




Primary Outcome Measures :
  1. PK endpoints:Area under the insulin concentration curve(AUCins).0-12h [ Time Frame: 0-12 hours ]
    Area under the insulin concentration curve from 0 to 12 hours.

  2. PD endpoints: Area under the glucose infusion rate curve(AUCGIR).0-12h [ Time Frame: 0-12 hours ]
    Area under the glucose infusion rate curve

  3. PK endpoints: Maximum observed insulin concentration(Cins.max) [ Time Frame: 0-12 hours ]
    Maximum observed insulin concentration

  4. PD endpoints:maximum glucose infusion rate(GIRmax) [ Time Frame: 0-12 hours ]
    maximum glucose infusion rate


Secondary Outcome Measures :
  1. PK endpoint- Area under the insulin concentration curve(AUCins).0-2h [ Time Frame: 0 to 2 hours ]
    Area under the insulin concentration curve

  2. PK endpoint- Area under the insulin concentration curve(AUCins).0-6h [ Time Frame: 0 to 6 hours ]
    area under the insulin concentration curve

  3. PK endpoint- Area under the insulin concentration curve(AUCins).6-12h [ Time Frame: 6 to 12 hours ]
    area under the insulin concentration curve

  4. PK endpoint- Area under the insulin concentration curve(AUCins).0-infinity [ Time Frame: 0 hours to 24 hours ]
    area under the insulin concentration-time curve

  5. PK endpoint- time to maximum concentration( tmax) [ Time Frame: 0-12 hours ]
    time to maximum observed insulin concentration.

  6. PK endpoint- time(t)50%-ins(early) [ Time Frame: 0-12 hours ]
    time to half-maximum before Cins.max.

  7. PK endpoint- time(t)50%-ins(late) [ Time Frame: 0-12 hours ]
    time to half-maximum after Cins.max.

  8. PK endpoint- terminal elimination half-life (t½) [ Time Frame: 0-12 hours ]
    terminal elimination half-life calculated as t½=ln2/λz.

  9. PK endpoint- terminal elimination rate constant (λz) [ Time Frame: 0-12 hours ]
    terminal elimination rate constant of insulin.

  10. PD endpoint: area under the glucose infusion rate curve(AUCGIR).0-2h [ Time Frame: 0 to 2 hours ]
    area under the glucose infusion rate curve

  11. PD endpoint: area under the glucose infusion rate curve(AUCGIR).0-6h [ Time Frame: 0 to 6 hours ]
    area under the glucose infusion rate curve

  12. PD endpoint: area under the glucose infusion rate curve(AUCGIR).6-12h [ Time Frame: 6 to 12 hours ]
    area under the glucose infusion rate curve

  13. PD endpoint: time to maximum glucose infusion rate (tGIR.max) [ Time Frame: 0-12 hours ]
    time to maximum glucose infusion rate

  14. PD endpoint: time to half-maximum glucose infusion rate before GIRmax (tGIR,50%-early [ Time Frame: 0-12 hours ]
    time to half-maximum glucose infusion rate before GIRmax

  15. PD endpoint:time to half-maximum glucose infusion rate after GIRmax (tGIR.50%-late) [ Time Frame: 0-12 hours ]
    time to half-maximum glucose infusion rate after Maximum glucose infusion rate(GIRmax)

  16. PD endpoint: Onset of action [ Time Frame: 0-12 hours ]
    ime 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 Outcome Measures:
  1. Safety endpoints: Number of subjects with Adverse Events, clinically significant changes in Physical examination, Vital signs. Local tolerability/ Injection site reactions [ Time Frame: First dose to followup period (Total duration: 14 days approximate) ]

    Number of subjects with Adverse Events, 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 to Follow-up period (Total duration: 35 days approximate) ]

    Number of subjects with clinically significant changes in Laboratory safety parameters.

    Number of subjects with clinically significant changes in Electrocardiogram (ECG)




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male or post-menopausal female subject. Post-menopausal state is defined as no menses for 12 months 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 (BMI) 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.
  • Receipt of any medicinal product in clinical development within 30 days or five times its half-life (whichever is longer) before randomisation in this trial.
  • Any history or presence of clinically relevant comorbidity, as judged by the investigator.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04022317


Contacts
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Contact: Dr. Gursharan Singh +91 080 2808 ext 5479 gursharan.singh@biocon.com
Contact: Jayanti Panda +91 080 2808 ext 5304 Jayanti.Panda@biocon.com

Locations
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Germany
Profil Mainz GmbH Recruiting
Mainz, Germany
Contact: Leona Plum         
Sponsors and Collaborators
Biocon Limited
Profil Institut für Stoffwechselforschung GmbH
Investigators
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Principal Investigator: Dr. Leona P Mörschel Profil Mainz GmbH

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Responsible Party: Biocon Limited
ClinicalTrials.gov Identifier: NCT04022317     History of Changes
Other Study ID Numbers: EQR
First Posted: July 17, 2019    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Biocon Limited:
Recombinant Human Insulin R (rhi R)
Additional relevant MeSH terms:
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Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs