A Randomised, Double-blind, Three-period, Partially Replicated Crossover, Euglycaemic Glucose Clamp Study in Healthy Volunteers to Demonstrate Pharmacokinetic and Pharmacodynamic Similarity of Biocon Insulin N and Humulin® N
Sponsor study identifier
interventional
90
1 country
1
Study Start
June 15, 2019
Actual (reported)Primary Completion
December 21, 2019
Actual (reported)Study Completion
December 27, 2019
Actual (reported)Single-centre, randomised, double-blind, three-period, six-sequence, partially replicated design, crossover trial in healthy subjects
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 27, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 15, 2019
Actual (reported)June 29, 2019
Actual (reported)July 17, 2019
Actual (reported)December 21, 2019
Actual (reported)December 27, 2019
Actual (reported)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 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
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)
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
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
Biocon Insulin N is an intermediate-acting isophane suspension of human insulin produced by recombinant deoxyribonucleic acid(rDNA) technology utilizing Pichia pastoris (yeast).
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany
Dr. Grit Andersen
Profil Institut für Stoffwechselforschung GmbH Hellersbergstraße 9]
90 participants (actual enrollment reported by the registry).
First Submitted
June 29, 2019
First Posted
July 17, 2019
Study Start
June 15, 2019
Actual (reported)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
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
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
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
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
December 21, 2019
Actual (reported)Study Completion
December 27, 2019
Actual (reported)Last Updated
January 30, 2020
Record last verified: 2020-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: