| CTRI Number |
CTRI/2022/09/045313 [Registered on: 07/09/2022] Trial Registered Prospectively |
| Last Modified On: |
17/11/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A Phase I clinical trial to study the effect of two drugs, Insulin Glargine manufactured by BioGenomics limited and Lantus® by comparing pharmacokinetic and pharmacodynamic properties, safety and tolerability in healthy male volunteers. |
|
Scientific Title of Study
|
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 Lantus® (Insulin Glargine 100 IU/mL of Sanofi-Aventis) in healthy, adult, human male subjects under fasting condition |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 20-VIN-0108 Version 01 (06.03.2020) Version 2(20.04.2022) |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hiren Prajapati |
| Designation |
Principal Investigator |
| Affiliation |
Veeda Clinical research ltd. |
| Address |
Veeda Clinical Research Ltd.,
2nd, 3rd & 4th Floor, Shivalik Plaza-A,
Near I.I.M., Ambawadi
Ahmadabad
GUJARAT
380015
India |
| Phone |
91-79-67773000 |
| Fax |
|
| Email |
Hiren.P1891@veedacr.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Krishnananda Nayak |
| Designation |
Head, Clinical Development and Regulatory Affairs |
| Affiliation |
BioGenomics Ltd. |
| Address |
BioGenomics Limited
First Floor, Kothari Compound
Opposite Tikuji-ni-wadi
Thane
MAHARASHTRA
400610
India |
| Phone |
022-41617181 |
| Fax |
|
| Email |
k.nayak@biogenomics.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Krishnananda Nayak |
| Designation |
Head, Clinical Development and Regulatory Affairs |
| Affiliation |
BioGenomics Ltd. |
| Address |
BioGenomics Limited
First Floor, Kothari Compound
Opposite Tikuji-ni-wadi
Thane
MAHARASHTRA
400610
India |
| Phone |
022-41617181 |
| Fax |
|
| Email |
k.nayak@biogenomics.co.in |
|
|
Source of Monetary or Material Support
|
| BioGenomics Ltd, First floor, Kothari Compound Opposite Tikuji-ni-wadi Thane (West) |
|
|
Primary Sponsor
|
| Name |
BioGenomics Ltd |
| Address |
BioGenomics Limited
First Floor, Kothari Compound
Opposite Tikuji-ni-wadi
Thane (West),
Maharashtra, 400 610, India
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Hiren Prajapati |
Veeda Clinical Research Ltd |
2nd, 3rd & 4th Floor, Shivalik Plaza-A,
Near I.I.M., Ambawadi
Ahmadabad
GUJARAT |
91-79-67773000
Hiren.P1891@veedacr.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sangini Hospital ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Insulin Glargine |
BioGenomics Insulin Glargine 100IU/mL contains recombinant human insulin glargine, dose 0.4IU/kg. Once in 1 period. |
| Comparator Agent |
Lantus®
|
Lantus®,100 IU/mL contains recombinant human insulin glargine, dose 0.4IU/kg. Once in 1 Period
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
Body Mass Index (18.50-24.90 kg/m2), Glucose Tolerance Test (OGTT), HbA1c ≤ 5.7, plasma glucose, creatinine clearance >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 |
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To demonstrate equivalence in the pharmacokinetic and pharmacodynamic properties of Insulin Glargine 100 U/mL of BioGenomics Limited and Lantus® (Insulin Glargine) 100 U/mL of Sanofi-Aventis in healthy, adult, human male subjects under fasting condition
|
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 Outcome
|
| Outcome |
TimePoints |
| To assess and compare the safety and tolerability of subjects after single-dose administration of both Test and Reference products. |
Throughout the study |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
Final Enrollment numbers achieved (Total)= "48"
Final Enrollment numbers achieved (India)="48" |
|
Phase of Trial
|
Phase 1 |
Date of First Enrollment (India)
Modification(s)
|
01/11/2022 |
| Date of Study Completion (India) |
04/02/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet. We shall update when data is available for publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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 in healthy, adult, human male subjects under fasting conditions. |