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1 Clinical Trial Details (PDF Generation Date :- Thu, 20 Dec :50:30 GMT) CTRI Number Last Modified On 16/02/2018 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2017/02/ [Registered on: 02/02/2017] - Trial Registered Prospectively No Interventional Biological Randomized, Parallel Group, Active Controlled Trial A multi-center study to compare the effectiveness and safety of two different insulin injectable suspensions in treatment of patients diagnosed with type 2 diabetes mellitus A Prospective, Multi-center, Randomized, Double-blind, Parallel-group, Active-controlled, Phase III study to Compare the Efficacy, Safety and Immunogenicity of Premixed Human Insulin Biphasic (30% human insulin soluble injection and 70% human insulin isophane suspension) injectable suspension of MJ Biopharm Private Limited with Huminsulin 30/70 in treatment of patients diagnosed with type 2 diabetes mellitus Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) MJBPL-BHI 01; Version 3.0 Dated 16 June 2017 Protocol Number Designation Affiliation Address Details of Principal Investigator Details Contact Person (Scientific Query) Details Contact Person (Public Query) Phone Fax Designation Affiliation Address Details Contact Person (Scientific Query) Dr Taran Bedi Medical Monitor Phone Fax Designation Affiliation Address JSS Medical Research Private Limited 6th Floor, Vatika Mindscapes (Tower B), Plot 12/2, Sector 27D Faridabad HARYANA taran.bedi@jssresearch.com Details Contact Person (Public Query) Dr Shariq Anwar Head Operations Phone JSS MEDICAL RESEARCH INDIA PRIVATE LIMITED 6th Floor, Vatika Mindscapes (Tower B), Plot 12/2, Sector 27D Faridabad HARYANA page 1 / 8

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Fax Source of Monetary or Material Support > MJ Biopharm Private Limited, 113, Jolly Makers Chambers No. 2, Nariman Point, Mumbai , Primary Sponsor Details MJ Biopharm Private Limited Address 113, Jolly Makers Chambers No. 2, Nariman Point, Mumbai , Type of Sponsor JSS Medical Research Pvt Ltd List of Countries of Principal Investigator Dr Naval Vikram Pharmaceutical industry-n Address 6th Floor, Vatika Mindscapes (Tower B) Plot 12/2, Sector 27D Faridabad , of Site Site Address Phone/Fax/ All Institute of Medical Science Dr Mahesh DM Columbia Asia Hebbal CAHH,Bellary road, Kirloskar Business Park , Bangalore KARNATAKA Dr Rajeshwari Dr Vaishali Chetan Deshmukh Columbia Asia Yashwanthpur Deenanath Mangeshkar Hospital & Research Center Department of Medicine, AIIMS, Ansari Nagar , South m DELHI CARHY, No #26/4 Brigarde Gateway, Malleshwaram, Beside Metro , Bangalore KARNATAKA Department of Endocrinology, Deenanath Mangeshkar Hospital & Research Center, Erandawane , Pune MAHARASHTRA Dr Sumitav Barua Down town hospital Department of Medicine, 1st Floor, Old bulding, down town hospital, G.S. Road, Dispur, Guwahati , Kamrup ASSAM Dr KP Singh Fortis Hospital Department of Endocrinology, Fortis Hospital, Sector - 62, Phase - VIII, Mohali , Chandigarh maheshendocrine@gm ail.com researchendo@gmail.c om summit9001@gmail.co m drkp1292@gmail.com page 2 / 8

3 CHANDIGARH Dr D Anil Kumar Gandhi Hospital 3rd floor, Department of Medicine, Gandhi Hospital, Bhoiguda Road, Musheerabad, Secunderabad , Telangana, Hyderabad ANDHRA PRADESH Dr V Vivekanand King George Hospital Department of Endocrinology, Superspeciality Block, King George Hospital, Maharanipeta, Vizag , Visakhapatnam ANDHRA PRADESH Dr Shubha Laxmi Margekar Dr Deepak Khandelwal Dr Dinesh Agarwal Dr Sanjay Bhadada Dr A Gopal Rao Lady Hardinge Medical College Maharaja Agrasen Hospital Marwari Hospital and Research Center Post Graduate Institute of Medical Education and Research (PGIMER) Rajiv Gandhi Institute of Medical Sciences & RIMS Govt. General Hospital anilddrmd@gmail.com drvivek78@gmail.com Room no. 1014, 1st Floor, Old building, Lady Hardinge Medical dr_shubhalaxmi@rediff College, Shaheed mail.com Bhagat Singh Road, Diz Area, Connaught Place , Central DELHI Department of Endocrinology, Maharaja Agrasen Hospital, West Punjabi Bagh , West DELHI Room No. 3, First Floor, Marwari Hospital and Research Centre, ECRC-HEC Research Unit, S.J. Road, Athgaon, Guwahati , Assam, Kamrup ASSAM Department of Endocrinology, PGIMER, Sector , Chandigarh CHANDIGARH Department of Medicine, RIMS Hospital Research Wing, 2nd Floor, Beside Female Ward, Rajiv Gandhi Institute of Medical Sciences & RIMS Govt. General Hospital , Srikakulam khandelwalaiims@gmai l.com drdinesh944@gmail.co m bhadadash@rediffmail. com rimsresearch@gmail.co m page 3 / 8

4 Details of Ethics Committee Dr RP Agarwal SP Medical College & AG Hospital ANDHRA PRADESH Diabetes Care and Research Centre, SP Medical College & AG Hospital , Bikaner RAJASTHAN in of Committee Approval Status Date of Approval Is Independent Ethics Committee? Ethics Committee & Research Cell Marwari Hospital & Research Centre S.J Road, Athgaon, Guwahati , Assam, Ethics Committee Down town hospital, Dispur, G.S. Road Guwahati Ethics Committee for Human Research, Lady Hardinge Medical College New Delhi , Ethics Committee S.P. Medical College and AG Hospital HRM Cardiovascular Science & Research Bikaner , Rajasthan Committee Deenanath Mangeshkar Hospital and research Center Nr. Mhatre Bridge, Erandawane, Pune, Maharasthra Approved 01/05/2017 No Approved 30/01/2017 No Approved 12/05/2017 No Approved 11/12/2017 No Approved 04/04/2017 No Committee Columbia Asia Hospital, Columbia Asia Referral Hospital, Yashwanthpur. #26/4 Brigade Gateway, Malleshwaram, West Bengaluru , Karnataka, Approved 11/12/2017 No Committee Columbia Asia Hospital, Columbia Asia Referral Hospital, Yashwanthpur. #26/4 Brigade Gateway, Malleshwaram, West Bengaluru , Karnataka, Approved 11/12/2017 No Approved 11/05/2017 No page 4 / 8

5 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Committee PGIMER, Sector - 12 Chandigarh Committee Room No. 102, 1st Floor, Old O.T. Block, All Institute of Medical Sciences Ansari Nagar, New Delhi , Approved 28/11/2017 No Committee, Department of Medicine, Rajiv Gandhi Institute of Medical Science and RIMS Government General Srikakulam, Andhra Pradesh , Approved 30/01/2018 No Committee, Fortis Hospital, Sector-62, Phase-VIII, Mohali Punjab, Committee, King George Hospital, Maharanipeta, Visakhapatnam , Andhra Pradesh, Committee, Maharaja Agrasen Hospital, R.No.-614, 6th Floor West Punjabi Bagh New Delhi , Committee, Principal Ethics, Gandhi Medical College, Secunderabad Status Approved 24/11/2017 No Approved 03/07/2017 No Approved 15/02/2017 No Approved 21/02/2017 No Date Approved/Obtained 20/06/2017 Health Type Patients Condition Type 2 Diabetes Mellitus Type Details Intervention Comparator Agent Premix Human Insulin Biphasic 30/70, 100 IU/mL injectable suspension Huminsulin 30/70 100IU/mL suspension for injection Premix Human Insulin Biphasic 30/70 (30% human insulin soluble injection and 70% human insulin isophane suspension) 100 IU/mL injectable suspension manufactured by MJBPL Huminsulin 30/70 100IU/mL suspension for injection (biphasic isophane insulin page 5 / 8

6 Inclusion Criteria Age From Age To Gender Details Year(s) Year(s) Both Inclusion Criteria injection 30 % soluble insulin and 70 % isophane insulin) Patients eligible for enrolment in the study must meet all of the following criteria: 1.Male or female patients 18 to 65 years of age (both inclusive) 2.Patients who have been diagnosed with T2DM for at least 1 year prior to baseline visit 3.Patients have been receiving a stable dose of premix human insulin biphasic 30/70 (30% human insulin soluble injection and 70% human insulin isophane suspension) for at least 3 months prior to baseline visit 4.Patients with glycated haemoglobin level? 11 % at screening 5.Patients willing to provide signed written informed consent 6.Patients willing to comply all aspects of the protocol 7.Ability to self-inject insulin and perform 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 Exclusion Criteria Details Exclusion Criteria Patients meeting any of the following criteria must not be enrolled: 1.Patients with history or evidence of hypersensitivity to insulin or its excipients 2.Patient who has received/receiving insulin of animal origin 3.Patient with history or evidence of recurrent severe hypoglycaemia within 6 months at baseline visit 4.Patients with uncontrolled T2DM, diabetic ketoacidosis requiring hospitalization within 6 months at baseline visit 5.Patients with use of insulin pump within 6 months at baseline visit 6.Patients whose requirement for total daily dose of insulin is > 1 IU/kg 7.Patients with serum AIA level above 20 U/mL 8.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 9.Patients who have positive serology for hepatitis B virus (HBV) or hepatitis C (HCV) or human immunodeficiency virus (HIV) infections 10.Patients receiving glucagon-like peptide 1 mimetics (GLP-1) 11.Patients receiving treatment with thiazolidinedione (TZD) within the last 3 months at baseline visit 12.Women of childbearing potential not willing to use acceptable method of contraception 13.Women who are pregnant or nursing mothers 14.Patients with body mass index (BMI) 14 consecutive days) glucocorticoids within 4 weeks prior to baseline visit 18.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 19.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 page 6 / 8

7 with the study protocol or affect patient s safety in the study 20.Has participated in any other clinical trial 6 months before the study entry Method of Generating Random Sequence Method of Concealment Blinding/Masking Computer generated randomization Centralized Participant and Investigator Blinded Primary Outcome Outcome Timepoints Change in HbA1c from baseline 12 Weeks and 24 weeks Secondary Outcome Outcome Timepoints Efficacy: 1.Proportion of patients with change in HbA1c 2.Change in insulin dose between the two treatment arms 3.Change in FPG and PPG 4.Change in body weight Immunogenicity: 1.Correlation between the % change in HbA1c and % change in AIA with absolute change in total insulin dose as covariate 2.Compare the change in level of serum AIA Safety: 1.Adverse events including clinically significant laboratory change that occur during the study Baseline, Week 12 and Week 24 Target Sample Size Phase of Trial Phase 3 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Total Sample Size=200 Sample Size from =200 15/03/2017 No Date Specified Years=0 Months=10 Days=0 Not Applicable Completed None Yet This is a prospective, multicenter, randomized, double-blind, parallel-group, active-controlled, Phase III study to compare the efficacy, safety and immunogenicity of premixed human insulin biphasic (30% human insulin soluble injection and 70% human insulin isophane suspension) injectable suspension of MJ Biopharm Private Limited (MJBPL) with Huminsulin 30/70 in treatment of patients diagnosed with type 2 diabetes mellitus The Primary Objective of the study is to compare the change in glycated haemoglobin A1c (HbA1c) level from baseline to end of 12 weeks in page 7 / 8

8 Powered by TCPDF ( PDF of Trial patients diagnosed with type 2 diabetes mellitus (T2DM) receiving premix human insulin biphasic 30/70 of MJBPL versus Huminsulin 30/70. To compare the change in glycated haemoglobin A1c (HbA1c) level from baseline to end of 24 weeks in patients diagnosed with type 2 diabetes mellitus (T2DM) receiving premix human insulin biphasic 30/70 of MJBPL versus Huminsulin 30/70. The secondary objectives of the study are to evaluate the following: 1. Immunogenicity of the investigational product 2. Safety of the investigational product page 8 / 8