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CTRI Number  CTRI/2021/11/037994 [Registered on: 12/11/2021] Trial Registered Prospectively
Last Modified On: 23/08/2022
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 Phase III clinical study of Insulin Glargine in Adults with Type 2 Diabetes. 
Scientific Title of Study   A Prospective, Multi-center, Randomized, Open-Label, Parallel-group, Active-controlled, Phase III Study to Compare the Efficacy, Safety, and Immunogenicity of Insulin Glargine 100 IU/mL Injection of M.J. Biopharm Private Limited with Lantus® (Insulin Glargine Injection) 100 units/mL in the Treatment of Patients Diagnosed with Type 2 Diabetes Mellitus. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
MJBPL-RIG02, Version 1.0 Amendment 2.0; Dated: 27Aug 2021  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shreya Shah 
Designation  Head of Regulatory Affairs 
Affiliation  M. J. Biopharm Pvt. Ltd, 
Address  Regulatory Affairs Department 113 Jolly Maker Chambers No. 2 Nariman Point

Mumbai
MAHARASHTRA
400021
India 
Phone    
Fax    
Email  shreya.shah@mjbiopharm.com  
 
Details of Contact Person
Scientific Query  
Name  Shreya Shah 
Designation  Head of Regulatory Affairs 
Affiliation  M. J. Biopharm Pvt. Ltd, 
Address  Regulatory Affairs Department 113 Jolly Maker Chambers No. 2 Nariman Point

Mumbai
MAHARASHTRA
400021
India 
Phone    
Fax    
Email  shreya.shah@mjbiopharm.com  
 
Details of Contact Person
Public Query  
Name  Shreya Shah 
Designation  Head of Regulatory Affairs 
Affiliation  M. J. Biopharm Pvt. Ltd, 
Address  Regulatory Affairs Department 113 Jolly Maker Chambers No. 2 Nariman Point

Mumbai
MAHARASHTRA
400021
India 
Phone    
Fax    
Email  shreya.shah@mjbiopharm.com  
 
Source of Monetary or Material Support  
MJ Biopharm Pvt. Ltd 
 
Primary Sponsor  
Name  M J Biopharm Pvt Ltd 
Address  113 Jolly Maker Chambers No. 2 Nariman Point Mumbai 400021 Maharashtra 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 = 15  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Gogineni Naga Tejaswi  Aditya Multi Speciality Hospital  Department of Medicine 13-3-52, 3rd Line Guntur, Andhra Pradesh – 522001, India
Guntur
ANDHRA PRADESH 		 9160029464

researchaditya26@gmail.com 
Dr Indraneel Basu  Alliance Hospital  Department of Medicine Pischach Mochan, Ramakanth Nagar, Chetganj, Varanasi – 221001, India
Varanasi
UTTAR PRADESH 		 9935036063

dribasumd@yahoo.co.in 
Dr S K Sharma  Diabetes, Thyroid and Endocrine Centre  A-1, Madrampura, Near 4 No.ESI hospital, Ajmer Road, Sodala, Jaipur – 302 006
Jaipur
RAJASTHAN 		 9829010233

sksharmacr@gmail.com 
Dr Rupam Das  Downtown Hospital Limited  Department of Medicine G S Road Dispur Guwahati, Kamrup, Metropolitan, Assam – 781006, India
Kamrup
ASSAM 		 9864116999

rupamdas_in@yahoo.com 
Dr Srikanth Kongura  Endolife Speciality Hospitals Pvt. Ltd.  Door number 12-12-94, Old Club Road, Kothapet, Guntur -522001
Guntur
ANDHRA PRADESH 		 9849945577

srikanthendo@gmail.com 
Dr Parag Shah  Gujarat Endocrine center  2nd Floor, Silver Brook-B, Upp doctor House, Parimal Crossing, Ahmadabad- 6
Ahmadabad
GUJARAT 		 7926639840

paragendo@gmail.com 
Dr Girithara Gopalakrishnan J  K.G Hospital & Post Graduate Medical Institute  Regional Diabetic Center No. 5 Arts College Road,Coimbatore – 641018, India
Coimbatore
TAMIL NADU 		 9443170088

drgirimd@yahoo.com 
Dr Pramod Gandhi  Kingsway hospital  44-Kingsway , Nagpur-440001
Nagpur
MAHARASHTRA 		 9823042258

drpdgandhi1@yahoo.co.in 
Dr K Newton Issac   Kurnool Medical College  Dept. of General Medicine, Budhawara Peta, Kurnool, Andhra Pradesh - 518002
Kurnool
ANDHRA PRADESH 		 9000389931

drnewtonissac@gmail.com 
Dr Amol Dange  Lifepoint Multispeciality Hospital  Department of Medicine 145/1, Mumbai Bangalore Highway, Near Hotel Sayaji, Wakad, Pune – 411057
Pune
MAHARASHTRA 		 9823912040

amoldange298@gmail.com 
Dr Sanjay Bhadada  Nehru Hospital, PGIMER  Department of Endocrinology PGIMER Sector 12 Chandigarh 160012 India
Chandigarh
CHANDIGARH 		 9876602448

bhadadask@gmail.com 
Dr Rakesh Sahay  Osmania General Hospital  Department of Endocrinology, Osmania General Hospital, Osmania Medical College, Afzalgunj, Hyderabad – 500095, Telangana, India
Hyderabad
TELANGANA 		 9849597507

sahayrk@gmail.com 
Dr Balkishan Gupta  S. P. Medical College Bikaner  Department of Medicine Bikaner, Rajasthan 334001
Bikaner
RAJASTHAN 		 9829176143

bkgbkn@rediffmail.com 
Dr Uday Phadke  Sahydari Super speciality Hospital  30-C Karve Road, Erandwane, Pune -411004
Pune
MAHARASHTRA 		 9822025180

uday@drudayphadke.com 
Dr Keyur Brahme  Sir Sayajirao General Hospital (SSG Hospital)  Department of Medicine Medical College Baroda, Jail Road (Indira Avenue), Anandpura, Vadodara – 390001, Gujarat, India.
Vadodara
GUJARAT 		 97277729105

keyurbrahme@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 15  
Name of Committee  Approval Status 
Ethic Committee Downtown Hospital Guwahati  Approved 
Ethics Committee SP Medical College Bikaner  Approved 
Human Welfare Ethical Committee  Approved 
Institutional Ethic Committee for Human Research Medical College Baroda  Approved 
Institutional Ethic Committee Osmania Medical College Hyderabad  Approved 
Institutional Ethics committee Aditya Multi Speciality Hospital Guntur  Approved 
Institutional Ethics Committee Endolife  Approved 
Institutional Ethics Committee Kurnool Medical College  Approved 
Institutional Ethics Committee PGIMER  Approved 
Institutional Ethics Committee Shubham Sudbhawana Super Specialty Hospital  Approved 
Institutional Ethics Committee, K.G Hospital Coimbatore  Approved 
Kingsway Hospital Ethics committee  Approved 
LPR Ethics Committee - Lifepoint Multispeciality Hospital Pune  Approved 
Sahyadri Hospitals Ltd. Ethics committee  Approved 
Sangini Hospital Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
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  Insulin Glargine 100IU/ml  Individualised dosage and frequency. Subcutaneous Administration. Duration of treatment: 24 weeks. Manufactured by M. J. Biopharm Pvt. Ltd. 
Comparator Agent  Lantus®, Insulin Glargine 100IU/ml  Individualised dosage and frequency. Subcutaneous administration. Duration of treatment: 24 weeks. Manufactured by Sanofi 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Willing to provide the written informed consent
2. Male and female adult patients, at an age of 18 to 65 years, both inclusive
3. Type 2 diabetes mellitus based on the disease diagnostic criteria provided by World Health Organization (WHO) guidelines
4. Duration of diabetes mellitus greater than or equal to 12 months
5. Receiving 2 or more Oral Antidiabetic Medicinal products (OAMs) at stable doses for 12 weeks prior to screening, with or without Lantus®. The use and dose of oral agents in combination with insulin had to be in accordance with the product label. If on Lantus, must be on once daily stable dose (±15% variation in dose) for at least 3 months prior to screening.
6. Haemoglobin level of ≥9.0 g/dL
7. Glycosylated haemoglobin (HbA1c) between 7.5% and 10.5%.
8. Body mass index (BMI) between 18 and 38 kilograms/meter square (kg/m²)
9. Stable weight, with no significant and appreciable loss or gain, in the 3 months prior to screening; this information will be obtained by patient interview during medical history
10. Female patients of childbearing potential, in addition to having a negative serum pregnancy test, must be willing to use a reliable means of contraception (other than hormonal contraceptives) e.g. barrier method (diaphragm, condom, etc.), surgical sterilization (at least 6 months prior to study drug administration) or abstinence for the duration of the study. Patients should use the reliable method of contraception from screening, during study and up to and for at least two weeks after treatment discontinuation
11. Ability and willingness to administer study medication daily as injections to abdomen, thigh, or upper arm
12. As determined by the investigator, the patient should be capable and willing to do the following:
a. Perform self-monitored blood glucose (SMBG)
b. Complete Subject diaries as instructed
c. Be receptive to diabetes education
d. Be able and willing to adhere to the protocol requirements 
 
ExclusionCriteria 
Details  1. Type 1 diabetes mellitus
2. Used any other insulin except Lantus® within the previous 30 days. Have been on Lantus® more than once daily within the previous 30 days.
3. Exposed to a biosimilar insulin glargine within the previous 90 days
4. History of taking basal bolus therapy or, in the investigator’s opinion, required mealtime insulin to achieve target control
5. Type 2 Diabetes patients with metabolic complications such as diabetic ketoacidosis within 6 months of screening visit
6. Used glucagon-like peptide 1 (GLP-1) agonist within the previous 90 days
7. Used thiazolidinediones (TZDs) within the previous 90 days
8. Excessive insulin resistance at study entry (total insulin dose ≥1.5 U/kg)
9. More than one episode of severe hypoglycemia defined as an event requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions, within 6 months prior to study entry
10. Known hypersensitivity or allergy to insulin glargine or its excipients OR history of significant allergic drug reactions
11. Receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy at pharmacological doses (excluding topical, intra-articular, intra-ocular, or inhalational preparations and physiologic replacement doses for adrenal deficiency) or had received such therapy within 4 weeks prior to screening
12. Inadequately treated hypertension (systolic ≥150 mm Hg or diastolic ≥100 mm Hg)
13. Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of < 60 mL/min/1.73 m2 at screening.
14. Evidence of hypokalemia (serum potassium < 3.5 mmol/L at screening)
15. Known case of chronic liver disease or hepatic impairment, defined as any serum liver enzymes (alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transferase, alkaline phosphatase) ≥ 2.5 times ULN at screening
16. Congestive heart failure (New York Heart Association [NYHA] class III & class IV), angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, transient ischemic attack, or pulmonary embolism or any other established major cardiovascular disease prior to screening
17. History of or ongoing cardiac dysrhythmias requiring treatment, such as uncontrolled atrial fibrillation
18. Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardize patient’s safety or compliance with the protocol
19. Active cancer or personal history of cancer within previous 5 years (with the exception of basal cell carcinoma or carcinoma in situ)
20. Known to be human immunodeficiency virus (HIV) positive or have an acquired immunodeficiency syndrome-related illness, or positive HIV seropositivity at screening
21. Known active or chronic hepatitis B or hepatitis C infection, or Hepatitis B and Hepatitis C seropositivity at screening, if not related to vaccination
22. Blood transfusion or severe blood loss within 3 months prior to screening, or known haemoglobinopathy, hemolytic anemia, or sickle cell anemia
23. Prohibited medications which cannot be discontinued at randomization or anticipated initiation or change in concomitant medications known to affect glucose metabolism
24. Breastfeeding, pregnant, or intended to become pregnant during the course of the study, or were sexually active women of childbearing potential not actively practicing birth control using a method deemed to be medically acceptable by the investigator
25. Undergone a surgical procedure within 4 weeks prior to signing informed consent or has planned major surgery during the study.
26. Clinically significant laboratory values at screening which in the judgement of Investigator can interfere with study assessments or pose safety risk to the subject.
27. If participated in any other clinical trial within the last 6 months before the current study or concurrently enrolled/scheduled to be enrolled in any other type of medical research during the current study period.
28. Have any other condition (including history of/known drug or alcohol abuse or psychiatric disorder including dementia) that precludes the participant from following and completing the protocol as per judgment of the investigator. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Mean change in HbA1c from baseline to Week 24 compared with Lantus®  From baseline to end of treatment period (Week 24) 
 
Secondary Outcome  
Outcome  TimePoints 
Mean change in HbA1c from baseline to Week 12 compared with Lantus®  From baseline to Week 12 
Change in FPG and PPPG from baseline to Week 12 and Week 24  From baseline to Week 12 and Week 24 
Proportion of patients with HbA1c reduction of ≥1% from baseline to Week 12 and Week 24  From baseline to Week 12 and Week 24 
 
Target Sample Size   Total Sample Size="250"
Sample Size from India="250" 
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 3 
Date of First Enrollment (India)   15/11/2021 
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="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   A Prospective, Multi-center, Randomized, Open-Label, Parallel-group, Active-controlled Phase III study to Compare the Efficacy, Safety and Immunogenicity of Insulin Glargine 100 IU/mL injection of M.J. Biopharm Private Limited with Lantus® (Insulin Glargine Injection) 100 units/mL in the treatment of Patients diagnosed with Type 2 Diabetes Mellitus 

Primary Objective:

To determine the non-inferiority of Insulin Glargine of MJBPL to Lantus® (Insulin Glargine Injection), as measured by change in glycated haemoglobin A1c (HbA1c) over the treatment period

 
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