Comparison of Pharmacokinetic (PK) and Pharmacodynamic(PD) of Biocon Insulin 70/30 and Humulin® 70/30

NCT04022291 | Completed Phase 1 FDA Drug

• 1 other identifier: EQ7030
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 2

Brief Summary

Two-centre, randomised, double-blind, single dose, two-treatment, two-period, two sequence, crossover, 24-hour euglycaemic glucose clamp trial in healthy subjects.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (4)

• Pharmacokinetic endpoints: area under the insulin concentration curve (AUCins) 0-24h

  area under the insulin concentration curve

  0-24hour

• Pharmacokinetic endpoints: insulin concentration (Cins).max

  maximum observed insulin concentration.

  0-24hour

• Pharmacodynamic Endpoint: Area under curve (AUC)Glucose infusion rate (GIR).0-24h

  area under the glucose infusion rate curve

  0-24hour

• Pharmacodynamic Endpoint: maximum glucose infusion rate (GIRmax)

  maximum glucose infusion rate

  0-24hour

Secondary Outcomes (18)

• Pharmacokinetic endpoint: area under the insulin concentration curve(AUCins) 0-2h

  0-2hour

• Pharmacokinetic endpoint: area under the insulin concentration curve(AUCins) 0-6h

  0-6hour

• Pharmacokinetic endpoint: area under the insulin concentration curve(AUCins) 0-12h

  0-12hour

• Pharmacokinetic endpoint: area under the insulin concentration curve(AUCins)12-24h

  12-24hour

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

  0 to 24 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 and Follow-up period (Total duration: 35 days approximate)

Study Arms (2)

Biocon Insulin 70/30

EXPERIMENTAL

0.4 IU/kg Dose per administration, Subcutaneous Route of administration

Biological: Biocon Insulin 70/30

Humulin® 70/30

ACTIVE COMPARATOR

0.4 IU/kg Dose per administration, Subcutaneous Route of administration

Biological: Humulin ®70/30

Interventions

Humulin ®70/30 BIOLOGICAL

Humulin® 70/30 is a premixed suspension of human insulin of recombinant deoxyribonucleic acid (rDNA)origin, which contains 30% short-acting human soluble insulin and 70% intermediate-acting isophane insulin. Human insulin is produced by recombinant deoxyribonucleic acid (rDNA), technology utilizing a non-pathogenic laboratory strain of Escherichia coli.

Humulin® 70/30

Biocon Insulin 70/30 BIOLOGICAL

Biocon Insulin 70/30 is a premixed suspension of human insulin of recombinant deoxyribonucleic acid (rDNA)origin, which contains 30% short-acting human soluble insulin and 70% intermediate-acting isophane insulin. Biocon insulin is produced by recombinant deoxyribonucleic acid (rDNA) technology utilizing a non-pathogenic laboratory strain of Escherichia coli.

Biocon Insulin 70/30

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 subjects. 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 randomization 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 (2)

Profil Mainz GmbH & Co. KG Malakoff-Passage,Rheinstraße 4C D-55116

Mainz, Germany

Location

Profil Institut für Stoffwechselforschung GmbH Hellersbergstr. 9 D-41460 Neuss

Neuss, Germany

Location

Study Officials

• Oliver Klein, MD

  Profil Institut für Stoffwechselforschung GmbH Hellersbergstr. 9 D-41460 Neuss

  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: July 4, 2019
• First Posted: July 17, 2019
• Study Start: June 15, 2019
• Primary Completion: January 20, 2020
• Study Completion: January 27, 2020
• Last Updated: January 30, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)