| CTRI Number |
CTRI/2022/06/043169 [Registered on: 10/06/2022] Trial Registered Prospectively |
| Last Modified On: |
23/08/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
To compare PK, PD, safety and tolerability of recombinant human Insulin Aspart Mix 30(BioGenomics Ltd) vs NovoMix® 30 in male healthy volunteers. |
|
Scientific Title of Study
|
A Randomized, Double Blind, Single Center, Two Treatment, Two-Period, Two
Sequence, Crossover, Euglycemic clamp study to demonstrate equivalence in the
Pharmacokinetic and Pharmacodynamic properties of Insulin Aspart Mix 30 of
BioGenomics Limited and NovoMix® 30 of Novo Nordisk in healthy, adult, human
male subjects under fasting condition. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 20-VIN-0109 Version 2(01/04/2021), Amendment 001(10/02/2022) |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hiren Prajapati |
| Designation |
Principal Investigator |
| Affiliation |
Veeda Clinical Research |
| Address |
Veeda Clinical Research Pvt Ltd
Shivalik Plaza, Near I.I.M., Ambawadi
Veeda Clinical Research Pvt Ltd
Shivalik Plaza, Near I.I.M., Ambawadi
Ahmadabad
GUJARAT
380015
India |
| Phone |
91-7967773000 |
| Fax |
- |
| Email |
Hiren.P1891@veedacr.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Krishananda Nayak |
| Designation |
Head, Clinical development and Regulatory affairs |
| Affiliation |
BioGenomics Ltd |
| Address |
BioGenomics Limited
First Floor, Kothari Compound
Opposite Tikuji-ni-wadi
Thane (West)
Thane
MAHARASHTRA
400610
India |
| Phone |
02241617181 |
| Fax |
|
| Email |
k.nayak@biogenomics.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Krishananda Nayak |
| Designation |
Head, Clinical development and Regulatory affairs |
| Affiliation |
BioGenomics Ltd |
| Address |
BioGenomics Limited
First Floor, Kothari Compound
Opposite Tikuji-ni-wadi
Thane (West)
Thane
MAHARASHTRA
400610
India |
| Phone |
02241617181 |
| Fax |
|
| Email |
k.nayak@biogenomics.co.in |
|
|
Source of Monetary or Material Support
|
| BioGenomics Limited, First floor,kothari compound,Opp Tiku-ji-ni-wadi,chitalsar Manpada,Thane-400610 |
|
|
Primary Sponsor
|
| Name |
BioGenomics Ltd |
| Address |
BioGenomics Limited
First Floor, Kothari Compound
Opposite Tikuji-ni-wadi
Thane (West) |
| 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 Pvt Ltd |
2nd, 3rd, 4th floor, Shivalik Plaza- A, Near I.I.M.,
Ambawadi,Ahmadabad-380015,
Gujarat, India
Ahmadabad
GUJARAT |
91-7967773000
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 Aspart Mix 30 |
BioGenomics insulin aspart mix 30- 100U/ml contains recombinant human soluble insulin aspart/ protamine-crystallized insulin aspart 30/70. Dose 0.3U/kg. Once in 10 days. |
| Comparator Agent |
NovoMix® 30 |
NovoMix® 30- 100U/ml contains recombinant human soluble insulin aspart/ protamine -crystallized insulin aspart 30/70. Dose 0.3U/kg. Once in 10 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
Hemoglobin: greater than or equal to 12.0 gm%, subject with normal results of 2 hours oral glucose tolerance test (OGTT). Subjects having clinically acceptable 12-lead electrocardiogram. BMI between 18.50 and 24.90 kg/m2
|
|
| ExclusionCriteria |
| Details |
Hypersensitivity to exogenous insulin,History of hyperglycaemia/hypoglycemia, History of diabetic ketoacidosis, Major illness within past 3 months |
|
|
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 PK and PD properties of recombinant Insulin Aspart Mix 30 as test product (manufactured by BioGenomics Ltd) with NovoMix® 30 of Novo Nordisk in healthy, adult, human male subjects |
PK-22, PD-183 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess and compare the safety and tolerability of single-dose administration of both Test and Reference products. |
Throughout the study |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
14/06/2022 |
| Date of Study Completion (India) |
25/09/2022 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet. We shall update once the 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 Phase I randomized, double-blind, single-center, two treatment, two period, two sequence, crossover, euglycemic clamp study to demonstrate equivalence in the pharmacokinetic and pharmacodynamic properties of BioGenomics Insulin Aspart Mix 30 and Novomix ® 30 and to assess safety and tolerability in healthy, adult, human male subjects under fasting conditions. |