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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05413863
Other study ID # BIO-INS500-101
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date May 30, 2022
Est. completion date December 12, 2022

Study information

Verified date May 2023
Source Biocon Limited
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

The present study is designed to demonstrate pharmacokinetic and pharmacodynamic equivalence of Biocon's Human Insulin R U-500 with Humulin® R U-500 in healthy subjects. The treatment consists of one single dose of the test or reference product, administered during each of the three study periods, separated by 5-7 days between each dosing. The planned trial duration for each subject is about 18 to 44 days. Eligible subjects will undergo three euglycaemic clamp examinations (each of 24 hours duration). Depending on the sequence in which a particular subject is randomized, each subject will either undergo two clamps with administration of test product plus one clamp with administration of reference product, or, two clamps with administration of reference product plus one clamp with administration of test product, in random order.


Recruitment information / eligibility

Status Completed
Enrollment 78
Est. completion date December 12, 2022
Est. primary completion date December 12, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Biocon's Human Insulin R U-500
Biocon's Human Insulin R U-500 (Insulin Human Injection 500 units/mL), 3 mL cartridges (containing 1,500 units of insulin).
Humulin® R U-500 (US Reference Product)
Humulin® R U-500 (US Reference Product), 3 mL single-patient-use KwikPen® (containing 1,500 units of insulin)

Locations

Country Name City State
Germany Profil Institut für Stoffwechselforschung GmbH 9 Neuss

Sponsors (2)

Lead Sponsor Collaborator
Biocon Limited Profil Institut für Stoffwechselforschung GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Other Safety endpoint: Number of subjects with Adverse Events (AEs) Signing of Informed consent form (ICF) to follow-up period (Total duration: 44 days approximate)
Other 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)
Other 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)
Other Safety endpoint: Local tolerability assessment / Injection site reactions Number of subjects with Injection Site Reactions Signing of Informed consent form (ICF) to follow-up period (Total duration:44 days approximate)
Other Safety endpoint: Number of subjects with clinically significant changes in Laboratory safety parameters Signing of Informed consent form (ICF) to follow-up period (Total duration:44 days approximate)
Other Safety endpoint: Number of subjects with clinically significant changes in ECG Signing of Informed consent form (ICF) to follow-up period (Total duration:44 days approximate)
Primary Primary pharmacokinetics (PK) endpoint: area under the insulin concentration curve(AUCins).0-12h Area under the insulin concentration curve 0 to12 hours
Primary Primary pharmacokinetics (PK) endpoint: maximum observed insulin concentration(Cins.max) Maximum observed insulin concentration NAP (Not Applicable)
Primary 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 Primary pharmacodynamics (PD) endpoint:maximum observed glucose infusion rate (GIRmax) Maximum observed glucose infusion rate NAP (Not Applicable)
Secondary Secondary pharmacokinetics (PK) endpoint: area under the insulin concentration-time curve(AUCins).0-infinity Area under the insulin concentration-time curve 0 hours to 24 hours
Secondary Secondary pharmacokinetics (PK) endpoint: area under the insulin concentration-time curve(AUCins).0-24h Area under the insulin concentration-time curve 0 to 24 hours
Secondary Secondary pharmacokinetics (PK) endpoint: area under the insulin concentration-time curve (AUCins).12-24h Area under the insulin concentration-time curve 12 to 24 hours
Secondary Secondary pharmacokinetics (PK) endpoint:time to maximum observed insulin concentration (tmax.ins) Time to maximum observed insulin concentration 0 to 24 hours
Secondary Secondary pharmacokinetics (PK) endpoint:terminal elimination rate constant of insulin (?z) Terminal elimination rate constant of insulin 0 to 24 hours
Secondary Secondary pharmacokinetics (PK) endpoint: terminal elimination half-life (t½) Terminal elimination half-life calculated 0 to 24 hours
Secondary Secondary pharmacokinetics (PK) endpoint: time(t)50%-Insulin (INS)(early) Time to half-maximum before Cmax 0 to 24 hours
Secondary Secondary pharmacokinetics (PK) endpoint: time(t) 50%-Insulin (INS)(late) Time to half-maximum after Cmax 0 to 24 hours
Secondary Secondary pharmacodynamics (PD) endpoint: areas under the glucose infusion rate curve(AUCGIR).0-24h Area under the glucose infusion rate curve 0 to 24 hours
Secondary Secondary pharmacodynamics (PD) endpoint: areas under the glucose infusion rate curve(AUCGIR).12-24h Area under the glucose infusion rate curve 12 to 24 hours
Secondary Secondary pharmacodynamics (PD) endpoint: time to maximum glucose infusion rate(tmax.GIR) Time to maximum glucose infusion rate 0 to 24 hours
Secondary Secondary pharmacodynamics (PD) endpoint:time to half-maximum glucose infusion rate before GIRmax (tGIR.50%-early) Time to half-maximum glucose infusion rate before GIRmax 0 to 24 hours
Secondary Secondary pharmacodynamics (PD) endpoint: time to half-maximum glucose infusion rate after GIRmax (tGIR.50%-late) Time to half-maximum glucose infusion rate after GIRmax 0 to 24 hours
Secondary Secondary pharmacodynamics (PD) endpoint: Onset of action, time from trial product administration until plasma glucose concentration has decreased at least 5 mg/dL from baseline, Time from trial product administration until plasma glucose concentration 0 to 24 hours
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