To compare PK, PD, safety and tolerability of recombinant human insulin aspart (BioGenomics) vs Novorapid® in male healthy volunteers

A Phase I double-blind randomized single-dose two period crossover euglycemic clamp study to demonstrate equivalence in the PK and PD properties of BioGenomics Insulin Aspart and NovoRapid and to assess safety and tolerability in healthy male subjects

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2016/05/006959

Enrollment

Registered

2016-05-23

Start date

Unknown

Completion date

Unknown

Last updated

2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: BGL Insulin Aspart: BioGenomics insulin aspart 100U/mL, contains recombinant human insulin aspart. Dose 0.2U/kg Control Intervention1: Novorapid®: Novorapid® 100U/mL, contains recombina

Eligibility

Inclusion criteria

Inclusion criteria: Hemoglobin: greater than or equal to 12.0 gm% Subjects without any evidence of impaired glucose tolerance in 2 hours Oral Glucose Tolerance Test (OGTT) at screening Absence of disease markers of HIV I & II, a negative P24 antigen test and negative HBsAg and HCVAb Comprehension of the nature and purpose of the study and willingness to comply with the requirements of the entire procedure Negative breath alcohol test at every check-in

Exclusion criteria

Exclusion criteria: History of hypoglycemia/hyperglycaemia History of diabetic ketoacidosis Any major illness in last three months or any significant ongoing chronic medical illness Recent history of or presence of active kidney or liver dysfunction A history of neuropsychiatric diseases

Design outcomes

Primary

Measure	Time frame
To demonstrate equivalence in the PK and PD properties of Recombinant Human Insulin Aspart 100 U/mL as Test product [manufactured by BioGenomics Limited (BGL)] with NovoRapid® 100 U/mL as Reference product [marketed by Novo Nordisk A/S] in healthy, adult, human male subjects under fasting conditions.Timepoint: PK-19 samples PD-35 samples	—

Secondary

Measure	Time frame
To assess and compare the safety and tolerability of single-dose administration of both Test and Reference productsTimepoint: Throughout the study	—

Countries

India

Contacts

Public ContactDr Chandrashekhar Bolmall MD

BioGenomics Limited

chandrashekhar.bolmall@biogenomics.co.in9122-41617181

Outcome results