CTRI/2019/04/018455 [Registered on: 08/04/2019] Trial Registered Prospectively
Last Modified On:
15/06/2022
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Biological
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
A comparative study of Insulin Aspart (manufactured by BioGenomics Ltd) with Insulin Aspart (NovoRapid) in patients of Type 2 Diabetes Mellitus.
Scientific Title of Study
A Randomized, Open Label, Parallel-group, Multi-center Phase 3 Study to Compare Efficacy and Safety of Recombinant Insulin Aspart (Manufactured by BioGenomics Limited) with NovoRapid® (Manufactured by Novo Nordisk), in Adult Patients with Diabetes Mellitus
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
BGL-IA-CTP301-V3 0ct 2018
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Dilip Javalkar
Designation
Assistant Manager
Affiliation
BioGenomics Limited.
Address
First Floor, Kothari Compound,
Opposite Tikuji-ni-Wadi,
Thane MAHARASHTRA 400010 India
Phone
91-22-41617178
Fax
91-22-41617199
Email
dilip.javalkar@biogenomics.co.in
Details of Contact Person Scientific Query
Name
Dr Dilip Javalkar
Designation
Assistant Manager
Affiliation
BioGenomics Limited.
Address
First Floor, Kothari Compound,
Opposite Tikuji-ni-Wadi,
Thane MAHARASHTRA 400010 India
Phone
91-22-41617178
Fax
91-22-41617199
Email
dilip.javalkar@biogenomics.co.in
Details of Contact Person Public Query
Name
Dr Dilip Javalkar
Designation
Assistant Manager
Affiliation
BioGenomics Limited.
Address
First Floor, Kothari Compound,
Opposite Tikuji-ni-Wadi,
Thane MAHARASHTRA 400010 India
Phone
91-22-41617178
Fax
91-22-41617199
Email
dilip.javalkar@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 Limited
Address
First Floor, Kothari Compound,
Opposite Tikuji-ni-Wadi,
Thane (W) - 400 610, Maharashtra, India.
Department of Medicine
Room No.8, cross wing,3rd
floor, Teaching Block
Department of Medicine,
AIIMS, Ansari Nagar,
New Delhi -110029, India New Delhi DELHI
011-26593678
navalvikram@gmail.com
Dr Manojitketan Mukhopadhyay
AMRI Hospital
MRI hospital, CIT scheme
LXXII, P4&5 Block A, Gariahar
Road, Dhakuria, Kolkata
700029 Kolkata WEST BENGAL
9830203242
mkmukhopadhyay@yahoo.co.in
Dr Debasis Basu
Apollo Gleneagles Hospital
58 Canal Circular Rd
Kadapara Phool Bagan Kankurgachi Kolkata West Bengal 700054 Kolkata WEST BENGAL
9831256908
drdbasu@yahoo.com
Dr Sambit Das
Apollo Hospital & Research Center
Apollo Hospitals 251 Sainik School Road Unit-15 Bhubaneswar Orissa 751005 Khordha ORISSA
9937848498
sambitd2001@yahoo.co.in
Dr Arthur Asirvatham
Arthur Asirvatham Hospital
42-A, Kuruvikaran Salai, Anna Bus Stand, Madurai-625020 Madurai TAMIL NADU
944751977
ajasirvathamresearch@yahoo.in
Dr Shrikant Deshpande
Ashirwad Hospital & Research Centre
Maratha Section, Near Jijamata Udyan, Ulhasnagar-421004 Thane MAHARASHTRA
9822017445
writetoshrikant@rediffmail.com
Dr Kalyan Mullick
Atharva Multispeciality Hospital and Research Centre
H-4/Comm-2, Construction div-21, UP Avas Vikas Parishad, Sector E, Lucknow-226003 Lucknow UTTAR PRADESH
Government Medical college
and Hospital, Nagpur,
Maharashtra, India 440003 Nagpur MAHARASHTRA
9822234566
drmilindvyawahare@yahoo.com
Dr Shivendra Verma
GSVM Medical College
Dept. of Medicine, Swaroop Nagar, Kanpur-208002 Kanpur Nagar UTTAR PRADESH
8400331063
dr.shivendra@gmail.com
Dr Mayura Kale
Ishwar Institute of Health Care
3rd Floor, Plot No. 7, Gut No 6/1, Padegaon, Beside Punjabi Bhawan, Jaisinghpura Aurangabad- 431001 Aurangabad MAHARASHTRA
9422713734
mayurakale@rediffmail.com
Dr Banshi Saboo
Jivraj Mehta Samrak Health Foundation Bakeri Medical Research Centre
Jivraj Mehta Samrak Health
Foundation Bakeri Medical
Research Centre,Near
Shreyas Crossing road, Jivraj
marg, Jivraj Park, Vasna
Ahmedabad- 380007 Ahmadabad GUJARAT
9824047676
banshisaboo@hotmail.com
Dr Thushanth Thomas
Kerala Institute of Medical Sciences
Kerala Institute of Medical
Sciences, post Box number: 1,
Anayara P.O.,
Thiruvanthapuram-695029,
Kerala. Thiruvananthapuram KERALA
09946105225
thushantht@yahoo.com
Dr Himanshu Dandu
King George’s Medical University
King George’s Medical
University, Lucknow-226003 Lucknow UTTAR PRADESH
Diabetes and Endocrine Clinic A unit of Vijaya Super Speciality Hospital, Raghava Cine Complex Road, Pogathota, Nellore - 524001 Nellore ANDHRA PRADESH
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
NovoRapid®
Dose 0.5 and 1.0 unit/kg/day Route of administration Subcutaneous(S.C.) Duration of treatment 24 weeks
Manufactured by Novo Nordisk
Intervention
Recombinant insulin aspart
Dose 0.5 and 1.0 unit/kg/day
Route of administration Subcutaneous(S.C.)
Duration of treatment 24 weeks
Manufactured by BioGenomics Limited.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
Patients who meet all of the following criteria will be included in the study:
1.Type 2 DM patients willing to give written informed consent and willing to take a maximum of 4 injections daily.
2.Patients with T2DM, diagnosed since at least 6 months, who have been treated with premix human insulin (one or more insulin injections), who are insulin aspart/insulin aspart mixes’ naive, daily for 3 months prior to the screening visit.
3.Current treatment with/without OADs; in case of patients on OADs unchanged dosing for 3 months prior to the screening visit.
4.HbA1c between 7.5% -10.0%, both inclusive.
5.Both sexes aged between 18 to 65 years.
6.Body Mass Index (BMI) ≥18kg/m2and ≤ 40 kg/m2.
7.Female patients who are not breastfeeding, and female patients of childbearing potential test negative for pregnancy, do not intend to become pregnant during the study, and agree to continue using a reliable method of birth control.
8.Willingness and ability to self-inject insulin, perform SMPG, and keep record in the patient diary.
ExclusionCriteria
Details
Patients who meet any of the following criteria will be excluded from the study:
1.Known or suspected hypersensitivity to insulin or related product(s).
2.Previous participation in this trial (participation is defined as randomization).
3.Patients on insulin analogs (other than premix human insulin).
4.Patients who have participated in an interventional medical, surgical, or pharmaceutical study within 30 days prior to screening or are likely to simultaneously participate in another therapeutic clinical study.
5.Patients with any other clinically significant disease(s) which, in the opinion of the Investigator could compromise the patient’s safety, the patient’s involvement in the study or overall interpretation of the trial data.
6.Cardiovascular disease such as stroke, unstable angina pectoris, myocardial infarction, coronary arterial bypass graft or angioplasty, congestive heart failure class III or IV as per New York Heart Association, within 6 months prior to screening.
7.Impaired liver function, defined as alanine transaminase ≥2.5 times upper limit of normal.
8.Patients who have less than 5 years of remission history from any malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer).
9.Patients who are doubtful to comply with study procedures for mental, psychological or social reasons.
10.Patients who have active proliferative retinopathy or macular edema.
11.Known/screening seropositive patients of HIV or HBV or HCV.
12.Women of child bearing potential who are not willing to follow a reliable and effective contraceptive measure during the course of the study and at least 1 week after the last visit.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
To compare the efficacy of recombinant insulin aspart (manufactured by BGL) with
NovoRapid® (manufactured by Novo Nordisk) by measuring Mean change in glycated haemoglobin (A1C) from Baseline to end of 12 weeks and from Baseline to end of 24 weeks
From baseline to end of 12 weeks and from baseline to end of 24 weeks
Secondary Outcome
Outcome
TimePoints
Mean change in the fasting plasma glucose from baseline to end of 12 weeks and from baseline to end of 24 weeks Mean change in the post-prandial plasma glucose (after standard meal challenge) from baseline to end of 12 weeks and from baseline to end of 24 weeks
Proportion of patients who achieve target A1C (7%) between the treatment groups at the end of 12 weeks and 24weeks.
From baseline to end of 12 weeks and from baseline to end of 24 weeks.
Target Sample Size
Total Sample Size="320" Sample Size from India="320" Final Enrollment numbers achieved (Total)= "0" Final Enrollment numbers achieved (India)="320"
Publications are under review. Shall be updated once published
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
The proposed study is designed
to compare the efficacy, safety and immunogenicity of insulin aspart [BGL] 100
U/mL with NovoRapid® [manufactured by Novo Nordisk], in patients with Type
2 (T2DM) diabetes mellitus.
This phase 3 study is for 6
months inclusive of the immunogenicity testing including 320 subjects. It aims
to compare immunogenicity of insulin aspart [BGL] with NovoRapid® [manufactured
by Novo Nordisk], by testing the anti-insulin antibodies. The study gives a
detailed comprehensive safety profile of insulin aspart [BGL] with reference
product NovoRapid® [manufactured by Novo Nordisk].