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

NCT04022304 | Completed Phase 1 FDA Drug

• 1 other identifier: EQN
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteer

Keywords

Recombinant Human Insulin N (rhi N)

Outcome Measures

Primary Outcomes (4)

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

  area under the insulin concentration curve

  0-24hour

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

  maximum observed insulin concentration

  0-24hour

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

  area under the glucose infusion rate curve

  0-24hour

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

  maximum observed glucose infusion rate

  0-24hour

Secondary Outcomes (14)

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

  0-24 hours

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

  0-12hour

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

  12-24hour

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

  0-24 hours

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

  0-24 hours

Other Outcomes (2)

• Safety endpoint: 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)

  Screening and Follow-up period (Total duration: 42 days approximate)

Study Arms (6)

Sequence: Humulin® N- Biocon Insulin N-Humulin® N

EXPERIMENTAL

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; Biological: Humulin® N

Sequence: Biocon Insulin N- Humulin® N- Humulin® N

EXPERIMENTAL

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; Biological: Humulin® N

Sequence: Humulin® N- Humulin® N-Biocon Insulin N

EXPERIMENTAL

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; Biological: Humulin® N

Sequence: Biocon Insulin N- Humulin® N- Biocon Insulin N

EXPERIMENTAL

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; Biological: Humulin® N

Sequence: Humulin® N-Biocon Insulin N- Biocon Insulin N

EXPERIMENTAL

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; Biological: Humulin® N

Sequence: Biocon Insulin N- Biocon Insulin N-Humulin® N

EXPERIMENTAL

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; Biological: Humulin® N

Interventions

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).

Sequence: Biocon Insulin N- Biocon Insulin N-Humulin® N; Sequence: Biocon Insulin N- Humulin® N- Biocon Insulin N; Sequence: Biocon Insulin N- Humulin® N- Humulin® N; Sequence: Humulin® N- Biocon Insulin N-Humulin® N; Sequence: Humulin® N- Humulin® N-Biocon Insulin N; Sequence: Humulin® N-Biocon Insulin N- Biocon Insulin N

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.

Sequence: Biocon Insulin N- Biocon Insulin N-Humulin® N; Sequence: Biocon Insulin N- Humulin® N- Biocon Insulin N; Sequence: Biocon Insulin N- Humulin® N- Humulin® N; Sequence: Humulin® N- Biocon Insulin N-Humulin® N; Sequence: Humulin® N- Humulin® N-Biocon Insulin N; Sequence: Humulin® N-Biocon Insulin N- Biocon Insulin N

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Profil Institut für Stoffwechselforschung GmbH

Neuss, Germany

Location

Study Officials

• Dr. Grit Andersen

  Profil Institut für Stoffwechselforschung GmbH Hellersbergstraße 9]

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Partially replicated design, crossover trial

Study Record Dates

• First Submitted: June 29, 2019
• First Posted: July 17, 2019
• Study Start: June 15, 2019
• Primary Completion: December 21, 2019
• Study Completion: December 27, 2019
• Last Updated: January 30, 2020

Record last verified: 2020-01

Locations

DE (1)