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

Biocon Limited78 enrolled

Overview

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

The present study is designed to demonstrate pharmacokinetic and pharmacodynamic equivalence of Biocon Insulin 70/30 with Humulin® 70/30 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 dosing. The planned trial duration for each subject is about 12 to 36 days. Eligible subjects will undergo two 24-hour euglycaemic clamp examinations, one after administration of the test product and one after administration of the reference product in random order.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Healthy Volunteer

Interventions

Humulin ®70/30BIOLOGICAL

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.

Biocon Insulin 70/30BIOLOGICAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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. 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 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.

Locations (2)

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

Mainz, Germany

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

Neuss, Germany

Outcomes

Primary Outcomes

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

area under the insulin concentration curve

Time frame: 0-24hour

Pharmacokinetic endpoints: insulin concentration (Cins).max

maximum observed insulin concentration.

Time frame: 0-24hour

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

area under the glucose infusion rate curve

Time frame: 0-24hour

Pharmacodynamic Endpoint: maximum glucose infusion rate (GIRmax)

maximum glucose infusion rate

Time frame: 0-24hour

Secondary Outcomes

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

area under the insulin concentration curve

Time frame: 0-2hour

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

area under the insulin concentration curve

Time frame: 0-6hour

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

area under the insulin concentration curve

Time frame: 0-12hour

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

area under the insulin concentration curve

Data from ClinicalTrials.gov

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