NCT05413863

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P75+ for phase_1 healthy-volunteers

Timeline
Completed

Started May 2022

Typical duration for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 30, 2022

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 7, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 10, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2022

Completed
Last Updated

May 9, 2023

Status Verified

May 1, 2023

Enrollment Period

7 months

First QC Date

June 7, 2022

Last Update Submit

May 8, 2023

Conditions

Healthy Volunteers

Keywords

Recombinant Human INsulin Equivalence-4RHINE-4PharmacokineticPharmacodynamicBiocon's Insulin R U-500Humulin® R U-500

Outcome Measures

Primary Outcomes (4)

  • Primary pharmacokinetics (PK) endpoint: area under the insulin concentration curve(AUCins).0-12h

    Area under the insulin concentration curve

    0 to12 hours

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

    Maximum observed insulin concentration

    NAP (Not Applicable)

  • Primary pharmacodynamics (PD) endpoint:area under the glucose infusion rate curve (AUCGIR)0-12h

    Area under the glucose infusion rate curve

    0 to 12 hours

  • Primary pharmacodynamics (PD) endpoint:maximum observed glucose infusion rate (GIRmax)

    Maximum observed glucose infusion rate

    NAP (Not Applicable)

Secondary Outcomes (14)

  • Secondary pharmacokinetics (PK) endpoint: area under the insulin concentration-time curve(AUCins).0-infinity

    0 hours to 24 hours

  • Secondary pharmacokinetics (PK) endpoint: area under the insulin concentration-time curve(AUCins).0-24h

    0 to 24 hours

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

    12 to 24 hours

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

    0 to 24 hours

  • Secondary pharmacokinetics (PK) endpoint:terminal elimination rate constant of insulin (λz)

    0 to 24 hours

  • +9 more secondary outcomes

Other Outcomes (6)

  • Safety endpoint: Number of subjects with Adverse Events (AEs)

    Signing of Informed consent form (ICF) to follow-up period (Total duration: 44 days approximate)

  • Safety endpoint: Number of subjects with Clinically significant changes in Physical examination

    Signing of Informed consent form (ICF) to follow-up period (Total duration: 44 days approximate)

  • Safety endpoint: Number of subjects with Clinically significant changes in Vital signs

    Signing of Informed consent form (ICF) to follow-up period (Total duration: 44 days approximate)

  • +3 more other outcomes

Study Arms (6)

Sequence: Biocon's Human Insulin R U-500-Biocon's Human Insulin R U-500- Humulin® R U-500

EXPERIMENTAL

Period 1:Biocon's Human Insulin R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe Period 2:Biocon's Human Insulin R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe Period 3:Humulin® R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe

Biological: Biocon's Human Insulin R U-500Biological: Humulin® R U-500 (US Reference Product)

Sequence: Biocon's Human Insulin R U-500-Humulin® R U-500- Humulin® R U-500

EXPERIMENTAL

Period 1:Biocon's Human Insulin R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe Period 2:Humulin® R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe Period 3:Humulin® R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe

Biological: Biocon's Human Insulin R U-500Biological: Humulin® R U-500 (US Reference Product)

Sequence: Biocon's Human Insulin R U-500-Humulin® R U-500-Biocon's Human Insulin R U-500

EXPERIMENTAL

Period 1:Biocon's Human Insulin R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe Period 2:Humulin® R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe Period 3:Biocon's Human Insulin R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe

Biological: Biocon's Human Insulin R U-500Biological: Humulin® R U-500 (US Reference Product)

Sequence: Humulin® R U-500-Biocon's Human Insulin R U-500-Biocon's Human Insulin R U-500

EXPERIMENTAL

Period 1:Humulin® R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe Period 2:Biocon's Human Insulin R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe Period 3:Biocon's Human Insulin R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe

Biological: Biocon's Human Insulin R U-500Biological: Humulin® R U-500 (US Reference Product)

Sequence: Humulin® R U-500 -Biocon's Human Insulin R U-500-Humulin® R U-500

EXPERIMENTAL

Period 1:Humulin® R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe Period 2:Biocon's Human Insulin R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe Period 3:Humulin® R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe

Biological: Biocon's Human Insulin R U-500Biological: Humulin® R U-500 (US Reference Product)

Sequence: Humulin® R U-500-Humulin® R U-500-Biocon's Human Insulin R U-500

EXPERIMENTAL

Period 1:Humulin® R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe Period 2:Humulin® R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD(Becton Dickinson) disposable syringe Period 3:Biocon's Human Insulin R U-500 single subcutaneous dose of 0.3 IU/kg using a U-500 BD (Becton Dickinson) disposable syringe

Biological: Biocon's Human Insulin R U-500Biological: Humulin® R U-500 (US Reference Product)

Interventions

Biocon's Human Insulin R U-500BIOLOGICAL

Biocon's Human Insulin R U-500 (Insulin Human Injection 500 units/mL), 3 mL cartridges (containing 1,500 units of insulin).

Sequence: Biocon's Human Insulin R U-500-Biocon's Human Insulin R U-500- Humulin® R U-500Sequence: Biocon's Human Insulin R U-500-Humulin® R U-500- Humulin® R U-500Sequence: Biocon's Human Insulin R U-500-Humulin® R U-500-Biocon's Human Insulin R U-500Sequence: Humulin® R U-500 -Biocon's Human Insulin R U-500-Humulin® R U-500Sequence: Humulin® R U-500-Biocon's Human Insulin R U-500-Biocon's Human Insulin R U-500Sequence: Humulin® R U-500-Humulin® R U-500-Biocon's Human Insulin R U-500
Humulin® R U-500 (US Reference Product)BIOLOGICAL

Humulin® R U-500 (US Reference Product), 3 mL single-patient-use KwikPen® (containing 1,500 units of insulin)

Sequence: Biocon's Human Insulin R U-500-Biocon's Human Insulin R U-500- Humulin® R U-500Sequence: Biocon's Human Insulin R U-500-Humulin® R U-500- Humulin® R U-500Sequence: Biocon's Human Insulin R U-500-Humulin® R U-500-Biocon's Human Insulin R U-500Sequence: Humulin® R U-500 -Biocon's Human Insulin R U-500-Humulin® R U-500Sequence: Humulin® R U-500-Biocon's Human Insulin R U-500-Biocon's Human Insulin R U-500Sequence: Humulin® R U-500-Humulin® R U-500-Biocon's Human Insulin R U-500

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male or post-menopausal female subjects. The 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/m2, both inclusive.
  • Fasting plasma glucose concentration ≤ 100 mg/dL.
  • Considered generally healthy upon completing the medical history and screening safety assessments, as judged by the Investigator.

You may not qualify if:

  • Known or suspected hypersensitivity to investigational medicinal products (IMPs) 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.
  • Systolic blood pressure \< 90 mmHg or \> 139 mmHg and/or diastolic blood pressure \< 50 mmHg or \> 89 mmHg after resting for at least 5 minutes in the 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Profil Institut für Stoffwechselforschung GmbH 9

Neuss, D-41460, Germany

Location

Study Officials

  • Dr Ulrike Hövelmann, MD

    Profil Institut für Stoffwechselforschung 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
PARALLEL
Model Details: Partially replicated design, crossover trial
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2022

First Posted

June 10, 2022

Study Start

May 30, 2022

Primary Completion

December 12, 2022

Study Completion

December 12, 2022

Last Updated

May 9, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)