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CTRI Number  CTRI/2020/03/024054 [Registered on: 18/03/2020] Trial Registered Prospectively
Last Modified On: 16/05/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Single Arm Study 
Public Title of Study   Phase IV study to assess the safety, efficacy and immunogenicity of MJ Pharma-BIOSULIN® 30:70 
Scientific Title of Study   A prospective, multi-center, phase IV study to assess the safety, efficacy and immunogenicity of BIOSULIN® 30:70 (Insulin Injection, Biphasic Isophane 100 IU/ml of M. J. Biopharm Private Limited) in treatment of patients diagnosed with type 2 diabetes mellitus 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
PHIB/MJBPL/PHASE IV/2019, V 1, 04 Sep 2019  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query  
Name  Dr Antaryami Maharana 
Designation  Head-Medical Affairs 
Affiliation  Abiogenesis Clinpharm Private Limited 
Address  8-2-596A B1, Road No. 10, Banjara Hills, Hyderabad, TS 500034

Hyderabad
TELANGANA
500034
India 
Phone  914038117077  
Fax    
Email  antaryami@abiogenesisclinpharm.com  
 
Details of Contact Person
Public Query  
Name  Archana Gaikwad 
Designation  DGM-Regulatory Affairs  
Affiliation  M J Biopharm Private Limited 
Address  L-7, M.I.D.C. Industrial Area, MIDC Road, Taloje, MIDC Rd, Navi Mumbai, Maharashtra 410208

Mumbai (Suburban)
MAHARASHTRA
410208
India 
Phone  912227402331  
Fax    
Email  agaikwad@mjbiopharm.com  
 
Source of Monetary or Material Support  
M J Biopharm Private Limited 
 
Primary Sponsor  
Name  M J Biopharm Private Limited 
Address  113, Jolly Makers Chambers No. 2, Nariman Point, Mumbai 400021, India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 8  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shobhit Shakya  Dr. Ram Manohar Lohiya Institute of Medical Sciences  Room No. 9, 1st floor, administrative block,Dr. Ram Manohar Lohiya Institute of Medical Sciences,Vibhuti Khand, Gomti nagar
Lucknow
UTTAR PRADESH 		 8618737280

mkhushi021@gmail.com 
Dr Atul V Rajkondawar  Government Medical College  Department of Medicine 1st floor ward No 47,Government Medical College,Medical Square
Nagpur
MAHARASHTRA 		 7744963350

digambarrahangdale2@gmail.com 
Dr Ved Prakash  Indira Gandhi Institute of Medical Sciences  Indira Gandhi Institute of Medical Sciences Allahabad bank, Bailey Rd, Sheikhpura, Patna, Bihar 800014
Patna
BIHAR 		 9472008685

vedprakashims@gmail.com 
Dr Syed Umar Quadri  Mahatma Gandhi Missions Medical College & Hospital  Mahatma Gandhi Missions Medical College & Hospital,Department of Clinical Pharmacology and Therapeutics,N-6, CIDCO, Aurangabad-431003
Aurangabad
MAHARASHTRA 		 7507779263

gaurav@ardent-cro.com 
Dr CS Anjaneyulu  Neelima Hospital  Department of Medicine 1st floor,Neelima Hospital, Sanath nagar, Hyderabad-500018
Hyderabad
TELANGANA 		 9440978535

csa008@gmail.com 
Dr Tanuja Manohar  NKP Salve Institute of Medical sciences and Lata Mangeshkar Hospital  Department of medicine,1st floor NKP Salve Institute of Medical sciences and Lata Mangeshkar Hospital,Digdoh hills, Nagpur,440019,Maharashtra
Nagpur
MAHARASHTRA 		 919822706335

tanuja.manohar9@gmail.com 
Dr Sagar Vivek Redkar  Redkar Hospital & Research Center  Department of Clinical Research,Room No 6, 1st floor Redkar Hospital & Research Center,Mumbai-Goa Highway,Oxelbag,Dhargal,Pernem
North Goa
GOA 		 8459008044

cromgoa@gmail.com 
Dr A Venketeshwar Rao  St. Theresas Hospital  Clinical Research Department, 2nd floor St. Theresas Hospital,Sanath Nagar, Hyderabad-500018
Hyderabad
TELANGANA 		 9177024456

narraupendra15@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 12  
Name of Committee  Approval Status 
Ethics Committee-GSVM Medical college  Approved 
Ethics Committee-Mohandai Oswal Hospital  Approved 
Institutional Ethics Commitee, Redkar Hospital & Research Center  Approved 
institutional Ethics committee, Narayana medical college  Approved 
Institutional Ethics Committee, NKP Salve Institute of Medical sciences and Lata Mangeshkar Hospital  Approved 
institutional Ethics committee, surakshaka multispeciality and diabetes hospital  Approved 
institutional Ethics committee, Vijay Vallabh Hospital  Approved 
Institutional Ethics committee,Government Medical College-Nagpur  Approved 
Institutional Ethics committee,Mahatma Gandhi Missions Medical College and Hospital  Approved 
Institutional Ethics committee,Neelima Hospital  Approved 
Institutional Ethics committee,St.Theresas Hospital  Approved 
Office of the Ethics committee IGMS Sheikhpura,Patna-14  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
No Objection Certificate 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Biosulin  100IU/ml Daily two to three times as advised by the physician Subcutaneous administration for 6 months  
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Patients who are willing to provide written, signed and dated informed consent (IEC/IRB approved) to participate in the study before initiating any study related procedures
2. Type II diabetic male or female adult patients, within 18 to 65 years of age(Inclusive)
3. Patients who are willing to comply with visit schedule and all aspects of the protocol requirements
4. Adult patients with type II diabetes mellitus who require Premix Human Insulin Biphasic 30/70 for the control of hyperglycemia according to the clinical judgment of the physician..
5. Patients with glycosylated/glycated hemoglobin (HbA1c) level ≤ 11 % at screening
6. Ability to self-inject insulin and perform self-monitoring of blood glucose (SMBG) measurements. Patients whose injection is being administered by caregiver/family member (only in the case wherein the patient has fear to self-inject or does not prefer to self-inject) will be enrolled 
 
ExclusionCriteria 
Details  1.History of Type I Diabetes mellitus or secondary diabetes mellitus or diabetes insipidus
2. Type 2 diabetic patients with metabolic complication such as diabetic ketoacidosis within 6 months of baseline visit
3. Patients who have used any other investigational agent in the past 3 months
4. Patients having mental incapacity, unwillingness or language barriers hindering adequate understanding or cooperation
5. Patients with history or evidence of hypersensitivity to the active substance (insulin) or to any of the excipients as mentioned in the local prescribing information
6. Women who are pregnant or nursing mothers. Women of childbearing potential not willing to use acceptable method of contraception
7. Any disorder which in the opinion of the treating physician might jeopardize subject’s safety or compliance with the protocol
8. Patient who has received/receiving insulin of animal origin
9. Patient with history or evidence of recurrent severe hypoglycemia within 6 months at baseline visit
10. Patients with use of insulin pump within 6 months at baseline visit
11. Patient’s having the any of the following laboratory results at screening
a. BUN > 30 mg/dL
b. ALT/AST levels ≥ 2.5 X ULN of the normal laboratory range
c. Serum creatinine level >2.0 mg/dL
12. Patients with known history of positive serology for hepatitis B virus (HBV) or hepatitis C (HCV) or human immunodeficiency virus (HIV) infections
13. Patients receiving glucagon-like peptide 1 mimetics (GLP-1)
14. Patients receiving treatment with thiazolidinedione (TZD) within the last 3 months at baseline visit
15. Patients with body mass index (BMI) <18 kg/m² and ≥40 kg/m² at screening
16. Patients who have undergone pancreatectomy or pancreas islet transplant or renal transplant
17. Patients receiving or have received within the last year any immunomodulation medications that would possibly modify antibody generation either at the enrollment or during the course of the study
18. Patients who have received/receiving (>14 consecutive days) glucocorticoids within 4 weeks prior to baseline visit
19. Patients with history or evidence of diabetic complications (diabetic retinopathy, diabetic neuropathy, or diabetic nephropathy), other complications related to T2DM other than those mentioned, or cardiac disorders, etc. which in the opinion of the investigator signifies patients’ ineligibility for the trial
20. Patients with alcohol or drug abuse or any other medical or surgical condition, including lifestyle (e.g. shift workers, irregularity with meal times, etc.) that in the opinion of investigator can interfere with the study protocol or affect patient’s safety in the study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Percentage of patients reporting adverse events
2.Percentage of patients reporting serious adverse events
3.Insulin antibody changes
 		 From baseline to week 24 
 
Secondary Outcome  
Outcome  TimePoints 
1.Improvement in HbA1c levels
2.Improvement in fasting blood glucose
3.Reduction in postprandial blood glucose  		 from baseline to week 24
 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   25/03/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Not yet  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   An open-label, prospective, multi centric, non-comparative, non-randomized phase IV clinical study to evaluate the post marketing safety, efficacy and immunogenicity of BIOSULIN® 30:70 (insulin injection, biphasic isophane 100IU/ml of M. J. Biopharm Private Limited) in routine clinical practice in patients with diabetes mellitus in India with current applicable laws and regulations.  
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