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

NCT04022317 | Completed Phase 1 FDA Drug

• 1 other identifier: EQR
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy Volunteer

Keywords

Recombinant Human Insulin R (rhi R)

Outcome Measures

Primary Outcomes (4)

• PK endpoints:Area under the insulin concentration curve(AUCins).0-12h

  Area under the insulin concentration curve from 0 to 12 hours.

  0-12 hours

• PD endpoints: Area under the glucose infusion rate curve(AUCGIR).0-12h

  Area under the glucose infusion rate curve

  0-12 hours

• PK endpoints: Maximum observed insulin concentration(Cins.max)

  Maximum observed insulin concentration

  0-12 hours

• PD endpoints:maximum glucose infusion rate(GIRmax)

  maximum glucose infusion rate

  0-12 hours

Secondary Outcomes (16)

• PK endpoint- Area under the insulin concentration curve(AUCins).0-2h

  0 to 2 hours

• PK endpoint- Area under the insulin concentration curve(AUCins).0-6h

  0 to 6 hours

• PK endpoint- Area under the insulin concentration curve(AUCins).6-12h

  6 to 12 hours

• PK endpoint- Area under the insulin concentration curve(AUCins).0-infinity

  0 hours to 24 hours

• PK endpoint- time to maximum concentration( tmax)

  0-12 hours

Other Outcomes (2)

• Safety endpoints: Number of subjects with Adverse Events, clinically significant changes in Physical examination, Vital signs. Local tolerability/ Injection site reactions

  First dose to followup period (Total duration: 14 days approximate)

• Safety endpoint: Number of subjects with clinically significant changes in Laboratory safety parameters, Electrocardiogram (ECG)

  Screening to Follow-up period (Total duration: 35 days approximate)

Study Arms (2)

Biocon Insulin R

EXPERIMENTAL

0.3 IU/kg Dose per administration, subcutaneous Route of administration

Biological: Biocon Insulin R

Humulin® R (regular insulin human)

ACTIVE COMPARATOR

0.3 IU/kg Dose per administration, subcutaneous Route of administration

Biological: Humulin®R

Interventions

Biocon Insulin R BIOLOGICAL

Biocon Insulin R is a short-acting human insulin, produced by recombinant deoxyribonucleic acid (rDNA) technology utilizing Pichia pastoris (yeast).

Biocon Insulin R

Humulin®R BIOLOGICAL

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.

Humulin® R (regular insulin human)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biocon Limited: lead
• Profil Institut für Stoffwechselforschung GmbH: collaborator

Study Sites (1)

Profil Mainz GmbH

Mainz, Germany

Location

Study Officials

• Dr. Leona P Mörschel

  Profil Mainz GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2019
• First Posted: July 17, 2019
• Study Start: June 18, 2019
• Primary Completion: September 15, 2019
• Study Completion: September 20, 2019
• Last Updated: July 28, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)