Clinical trial NCT04022317: Comparision of Pharmacokinetics(PK) and Pharmacodynamics(PD) of Biocon Insulin R and Humulin® R
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Keywords: Recombinant Human Insulin R (rhi R)
Lead sponsor: Biocon Limited
Sponsor class: INDUSTRY
Collaborators: name: Profil Institut für Stoffwechselforschung GmbH
First posted: 2019-07-17
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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

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.

Eligibility 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.

Primary outcomes:
measure: PK endpoints:Area under the insulin concentration curve(AUCins).0-12h
timeFrame: 0-12 hours
measure: PD endpoints: Area under the glucose infusion rate curve(AUCGIR).0-12h
timeFrame: 0-12 hours
measure: PK endpoints: Maximum observed insulin concentration(Cins.max)
timeFrame: 0-12 hours
measure: PD endpoints:maximum glucose infusion rate(GIRmax)
timeFrame: 0-12 hours
Secondary outcomes:
measure: PK endpoint- Area under the insulin concentration curve(AUCins).0-2h
timeFrame: 0 to 2 hours
measure: PK endpoint- Area under the insulin concentration curve(AUCins).0-6h
timeFrame: 0 to 6 hours
measure: PK endpoint- Area under the insulin concentration curve(AUCins).6-12h
timeFrame: 6 to 12 hours
measure: PK endpoint- Area under the insulin concentration curve(AUCins).0-infinity
timeFrame: 0 hours to 24 hours
measure: PK endpoint- time to maximum concentration( tmax)
timeFrame: 0-12 hours
measure: PK endpoint- time(t)50%-ins(early)
timeFrame: 0-12 hours
measure: PK endpoint- time(t)50%-ins(late)
timeFrame: 0-12 hours
measure: PK endpoint- terminal elimination half-life (t½)
timeFrame: 0-12 hours
measure: PK endpoint- terminal elimination rate constant (λz)
timeFrame: 0-12 hours
measure: PD endpoint: area under the glucose infusion rate curve(AUCGIR).0-2h
timeFrame: 0 to 2 hours
measure: PD endpoint: area under the glucose infusion rate curve(AUCGIR).0-6h
timeFrame: 0 to 6 hours
measure: PD endpoint: area under the glucose infusion rate curve(AUCGIR).6-12h
timeFrame: 6 to 12 hours
measure: PD endpoint: time to maximum glucose infusion rate (tGIR.max)
timeFrame: 0-12 hours
measure: PD endpoint: time to half-maximum glucose infusion rate before GIRmax (tGIR,50%-early
timeFrame: 0-12 hours
measure: PD endpoint:time to half-maximum glucose infusion rate after GIRmax (tGIR.50%-late)
timeFrame: 0-12 hours
measure: PD endpoint: Onset of action
timeFrame: 0-12 hours
Other outcomes:
measure: Safety endpoints: Number of subjects with Adverse Events, clinically significant changes in Physical examination, Vital signs. Local tolerability/ Injection site reactions
timeFrame: First dose to followup period (Total duration: 14 days approximate)
measure: Safety endpoint: Number of subjects with clinically significant changes in Laboratory safety parameters, Electrocardiogram (ECG)
timeFrame: Screening to Follow-up period (Total duration: 35 days approximate)
Locations:
city: Mainz
country: Germany
facility: Profil Mainz GmbH
Study officials:
affiliation: Profil Mainz GmbH
name: Dr. Leona P Mörschel
role: PRINCIPAL_INVESTIGATOR
References: