Trials Sponsors Conditions Drugs Pricing

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
+13 more secondary outcomes

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 ®70/30Biological

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.

Humulin® 70/30

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 Criteria

Age18 Years - 55 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (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.

Sponsors & Collaborators

Biocon Limited
Industrylead
Profil Institut für Stoffwechselforschung GmbH
Industrycollaborator

Study Sites (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

Study Officials

Oliver Klein, MD
Profil Institut für Stoffwechselforschung GmbH Hellersbergstr. 9 D-41460 Neuss
PRINCIPAL INVESTIGATOR

Enrollment

78 participants (actual enrollment reported by the registry).

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

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (18)

Other Outcomes (2)

Study Arms (2)

Biocon Insulin 70/30

Humulin® 70/30

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (18)

Other Outcomes (2)

Study Arms (2)

Biocon Insulin 70/30

Humulin® 70/30

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations