A Phase I clinical trial to study the effect of two drugs, Insulin Glargine manufactured by BioGenomics limited and LantusÂ® by comparing pharmacokinetic and pharmacodynamic properties, safety and tolerability in healthy male volunteers.

A double-blind, randomized, single-center, two treatment, four period, two sequence, replicate crossover, euglycemic clamp study to demonstrate equivalence in the pharmacokinetic and pharmacodynamic properties of Insulin Glargine 100 IU/mL of BioGenomics Limited and LantusÂ® (Insulin Glargine 100 IU/mL of Sanofi-Aventis) in healthy, adult, human male subjects under fasting condition

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/09/045313

Enrollment

Registered

2022-09-07

Start date

Unknown

Completion date

Unknown

Last updated

2022-11-21

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

Conditions

None listed

Interventions

Intervention1: Insulin Glargine: BioGenomics Insulin Glargine 100IU/mL contains recombinant human insulin glargine, dose 0.4IU/kg. Once in 1 period. Control Intervention1: LantusÂ® : LantusÂ®,100 IU/m

Eligibility

Inclusion criteria

Inclusion criteria: Body Mass Index (18.50-24.90 kg/m2), Glucose Tolerance Test (OGTT), HbA1c 80 mL/min, medical history, clinical examination including vital signs blood pressure, body temperature, radial pulse rate and respiratory rate, physical examination and systemic examination, Chest X-ray PA view

Exclusion criteria

Exclusion criteria: Hypersensitivity to exogenous insulin or any component of the product or related class of the drugs, . History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, urogenital, dermatological, neurological or psychiatric disease or disorder, History of hyperglycemia, History of hypoglycaemia

Design outcomes

Primary

Measure	Time frame
To demonstrate equivalence in the pharmacokinetic and pharmacodynamic properties of Insulin Glargine 100 U/mL of BioGenomics Limited and LantusÂ® (Insulin Glargine) 100 U/mL of Sanofi-Aventis in healthy, adult, human male subjects under fasting condition Timepoint: PK- 12: One pre- dose sample at 0.0 hrs and 11 post dose samples PD- 147: 3 pre-dose samples (-0.50, -0.33, -0.17 hrs) and 144 post dose samples (samples every 10 mins throughout the 24 hrs glucose clamp)	—

Measure

Time frame

To demonstrate equivalence in the pharmacokinetic and pharmacodynamic properties of Insulin Glargine 100 U/mL of BioGenomics Limited and LantusÂ® (Insulin Glargine) 100 U/mL of Sanofi-Aventis in healthy, adult, human male subjects under fasting condition Timepoint: PK- 12: One pre- dose sample at 0.0 hrs and 11 post dose samples PD- 147: 3 pre-dose samples (-0.50, -0.33, -0.17 hrs) and 144 post dose samples (samples every 10 mins throughout the 24 hrs glucose clamp)

—

Secondary

Measure	Time frame
To assess and compare the safety and tolerability of subjects after single-dose administration of both Test and Reference products.Timepoint: Throughout the study	—

Countries

India

Contacts

Public ContactKrishnananda Nayak

BioGenomics Ltd.

k.nayak@biogenomics.co.in022-41617181

Outcome results