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1 Clinical Trial Details (PDF Generation Date :- Thu, 18 Oct :14:31 GMT) CTRI Number Last Modified On 06/06/2017 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2015/01/ [Registered on: 14/01/2015] - Trial Registered Prospectively No Interventional Drug Randomized, Parallel Group, Active Controlled Trial EVALUATION OF EFFICACY AND SAFETY OF FDC OF THREE ANTIDIABETIC DRUGS VERSUS FDC OF TWO ANTIDIABETIC DRUGS TO IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2 DIABETES EVALUATION OF EFFICACY AND SAFETY OF FDC OF THREE ANTIDIABETIC DRUGS VERSUS FDC OF TWO ANTIDIABETIC DRUGS TO IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2 DIABETES: AN OPEN LABEL, RANDOMIZED, COMPARATIVE, MULTICENTRIC STUDY Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) SP/IP-114/1213, Version No. 00 Amendment 03 dated 03/07/15 Designation Affiliation Protocol Number Details of Principal Investigator Dr Nomita Bhandari Phone Fax Designation Affiliation General Manager and Head (SPLL) Sun House Plot No.201, B/1, Western Express Highway Goregaon(E) Maharashtra, Nomita.Bhandari@sunpharma.com Details Contact Person (Scientific Query) Dr Maulik Doshi Medical Monitor Phone Fax Designation Affiliation Sun Pharma laboratories Limited Tandalja Vadodara Gujarat maulik.doshi@sunpharma.com Details Contact Person (Public Query) Mr Guruprasad Palekar Project Manager ACME Plaza, Andheri Kurla Road, Andheri (E), , page 1 / 7

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Phone Fax Source of Monetary or Material Support > ACME Plaza,Andheri Kurla Road,Andheri(E), Type of Sponsor NIL List of Countries of Principal Investigator Dr Shrikant V Deshpande Primary Sponsor Details ACME Plaza,Andheri Kurla Road,Andheri(E), Pharmaceutical industry-n NIL of Site Site Phone/Fax/ Ashirwad Hospital & Research Centre Maratha Section, Near Jijamata Udyan Ulhasnagar , Mahrashtra , Dr Amit Asalkar Aster Aadhar Hospital R.S. No 628, Near Shastri Nagar, KMT Workshop, Kolhapur Kolhapur Dr Narayan Deogaonkar Dr Jigar I Gami Dr Himanshu Rana Deogaonkar Hospital GMERS Medical College & Hospital GMERS Medical College and General Hospital Vadodara Old Pandit Colony, Near KTHM College, Gangapur Road, Near K. T. H. M. College, Nashik. Maharashtra PIN: Nashik Medicine, S.G. High Highway, Near New Gujarat High Court, Sola, Ahmedabad Ahmadabad GUJARAT Medicine, GMERS Medical College and General Hospital, Gotri Vadodara Vadodara GUJARAT svshrikant@gmail.com asalkar.aacr@gmail.co m drnarayan_04@yahoo.c o.in drjigargami@yahoo.co.i n drhimanshurana@yaho o.com page 2 / 7

3 Details of Ethics Committee Dr Gouranga Sarkar Dr Arunansu Talukdar Dr Rakesh Kumar Sahay Dr Kalyan Kumar Gangopadhyay IPGME & R, SSKM Hospital Medical college Hospital Kolkata Osmania General Hospital Peerless Hospitex Hospital & Research Centre Limited Medicine, 244, AJC Bose Road Kolkata West Bengal. Kolkata WEST BENGAL Medicine, 88 College Street, Kolkata Kolkata WEST BENGAL Endocrinology,2nd floor, OP Building, Afzalgunj, Hyderabad , Andhra Pradesh Hyderabad ANDHRA PRADESH Department-Medicine, 360 Panchasayar, Kolkata West Bengal, Kolkata WEST BENGAL Dr Amit Vilas Sambare Sanjeevan Hospital Plot No.-23, Off Karve Road Erandawane, Pune Pune Dr Puneet Saxena SMS Hospital & Medical College Medicine, Room No- G-1, Ground floor, Jaipur , Rajasthan Jaipur RAJASTHAN m o.co.in of Committee Approval Status Date of Approval Is Independent Ethics Committee? Aster Aadhar Ethics Committee, R. S. No 628 B Ward Near Shastri Nagar, KMT Workshop, Kolhapur, Ethics Committee Sanjeevan Hospital, Plot No. 23, Off Karve Road, Erandavane, Pune Institution Ethics Committee, S.M.S. Medical College and Attached Hospital, Jaipur Committee Peerless Approved 09/11/2015 No Approved 20/12/2014 No Approved 13/05/2015 No Approved 16/05/2015 No page 3 / 7

4 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Hospital Campus, 360, Panchasayar, Kolkata West Bengal Committee Deogaonkar Hospital IEC, Old Pandit Colony, Near KTHM College, Gangapur Road Nashik Approved 03/01/2015 No Committee for Human Research, Office Chamber of the Principal, 88 College Street, Kolkata West Bengal Committee Osmania Medical College, Koti Hyderabad , Telanagana Committee, Ashirwad Hospital & Research Centre, Maratha Section, Near Jijamata Udyan Ulhasnagar , Mahrashtra ,. Committee, GMERS Medical College, Sola S.G. Highway, Near New Gujrat High Court, Ahmedabad Gujrat Institutional Human Ethics Committee, GMERS Medical College and General Hospital, Gotri, Vadodara390021, Gujarat IPGME&R Research Oversight Committee, 244 Acharya J.C Bose Road, Kolkata , West Bengal Status Approved 22/04/2015 No Approved 20/10/2015 No Approved 28/10/2014 No Approved 07/04/2015 No Approved 03/11/2015 No Approved 26/11/2014 No Date Approved/Obtained 18/07/2014 Health Type Patients Condition Type 2 Diabetes Mellitus Type Details Intervention FDC Glimepiride, voglibose and FDC Glimepiride, voglibose and page 4 / 7

5 Inclusion Criteria Comparator Agent Age From Age To Gender Details extended release metformin hydrochloride tablets FDC Glimepiride and Metformin ER Tablet Year(s) Year(s) Both Inclusion Criteria extended release metformin hydrochloride tablets ( ) mg ( ) mg The dose of this fixed dose combination was one tablet two times daily, for 24 weeks The dose was recommended just before the meal (or with the first bite of each main meal). FDC Glimepiride and Metformin hydrochloride ER tablets ( ) mg and ( ) mg. The dose of this fixed dose combination was One tablet two times a daily for 24 weeks. The dose was recommended just before the meal (or with the first bite of each main meal The following points were considered for inclusion criteria in this study: 1.Male or female patients who were aged between 18 years to 65 years 2.Patients who were diagnosed with type 2 diabetes 3.Patients who had HbA1c ratio of?7.5 and?10 4.Patients who had BMI of?23 and?30kg/m2 5.Patients who had postprandial blood glucose (2 hours post meal) concentration more than 200 mg/dl 6.Patients who were on treatment with stable dose of fixed dose combination of Glimepiride 1 mg + Metformin 500 mg twice daily OR fixed dose combination of Glimepiride 2 mg + Metformin 500 mg twice daily for at least 12 weeks before enrolment 7.Patients who willingly gave their informed consent Exclusion Criteria Details Exclusion Criteria The following points were considered for exclusion criteria in this study: 1.Pregnant, lactating women or women of childbearing age who were not willing to use an acceptable method of birth control during the study period 2.Patients who had type 1 diabetes 3.Patients who had fasting blood glucose concentration more than 270 mg/dl 4.Patients who had hypersensitivity to any of the investigational products 5.Patients who had significant renal or hepatic impairment 6.Patients who received long term insulin therapy (? 3 days of treatment was allowed) 7.Patients who had history of acute or chronic metabolic acidosis, including diabetic ketoacidosis and lactic acidosis 8.Patients who were in a state of diabetic coma or pre coma 9.Patients who had severe infection or serious trauma 10.Alcohol abused patients 11.Patients who were in New York Heart Association (NYHA) class III or IV category page 5 / 7

6 12.Patients who had congestive heart failure to be treated 13.Patients who had inflammatory bowel disease or intestinal ulcers or chronic enteric diseases related to digestion and absorption 14.Patients who were judged unfit for this study by investigator 15.Patients who were receiving Miconazole Method of Generating Random Sequence Method of Concealment Blinding/Masking Computer generated randomization Centralized Open Label Primary Outcome Outcome Timepoints Change in PPBG from baseline Change in HbA1c from baseline Time frame 12 Weeks and 24 Weeks Time frame 12 Weeks and 24 Weeks Secondary Outcome Outcome Timepoints Change in FBG Proportion of participants with HbA1c reduction of at least 1% at the end of 24 weeks Proportion of participants with PPBG 170 mg/dl at the end of 24 weeks Evaluation of Clinical Global Impression on Improvement (CGI-I). (Time frame: 12 weeks and 24 weeks) [Time frame: 24 weeks] [Time frame: 24 weeks] [Time frame: 4, 12, 24 weeks] 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=300 Sample Size from =300 16/03/2015 No Date Specified Years=2 Months=0 Days=0 Not Applicable Completed Efficacy and safety of FDC of Glimepiride, Voglibose and Metformin ER was determined in open label, randomized, comparative, multicentric, 29 weeks study (1 week of screening period, 4 weeks of run-in period and 24 weeks of treatment period) in 294 patients at 11 different centers across. Patients with type 2 diabetes and fulfilling all the inclusion criteria we re enrolled in the study. Two groups of patients who were receiving eith er fixed dose combination of Glimepiride 1 mg + Metformin ER 500 mg or fixed dose combination of Glimepiride 2 mg + Metformin ER 500 mg two times daily dose and met all inclusion the criteria and none of the exclusion criteria at screeningvisit were considered eligible for Run-in Period in the study. Patients were kept on same dose (of screening) for 4 weeks in run page 6 / 7

7 Powered by TCPDF ( PDF of Trial in period after successful screening and both the groups of patients were reevaluated for eligibility criteria after 28 days. Patients who met all the inclusion criteria and none of exclusion criteria were enrolled in the study and randomized to either dual drug therapy or triple drug therapy.the dose was taken just before meal or with the first bit e of each main meal. Patients on Glimepiride 1 mg + Metformin ER 500 mg twice daily group during Run-in Period were randomized when eligible to either receive Glimepiride 1 mg + Metformin ER 1000 mg twice daily or Glimepiride 1 mg + Voglibose 0.2 mg + Metformin ER 500 mg twic e daily for 24 weeks. Patients on Glimepiride 2 mg + Metformin ER 500 mg twice daily group during Run in Period were randomized when eligible t o either receive Glimepiride 2 mg + Metformin ER 1000 mg twice daily or Glimepiride 2 mg + Voglibose 0.2 mg + Metformin ER 500 mg twice daily for 24 weeks. Primary efficacy variables were Change in PPBG from baseline and Change in HbA1c from baseline. Secondary efficacy variables were Change in FBG from baseline, Proportion of participants with HbA1c reduction of at least 1% at the end of 24 weeks, Proportion of participants with PPBG < 170 mg/dl at the end of 24 weeks and evaluation of Clinical Global Impression on Improvement (CGI-I). In summary, based on the study results, it is concluded that FDC of three drugs (FDC of Glimepiride 1mg + Voglibose 0.2 mg + Metformin ER 500 m g group and FDC of Glimepiride 2 mg + Voglibose 0.2 mg + Metformin ER 500 mg group) is safe and effective in patients with type 2 DM. It is especially useful in ns, because of higher pancreatic beta-cell function, less insulin sensitive and consumption of carbohydrate as polishe d rice. It can also be an alternative for elderly patients and in those with he patic impairment or mild to moderate renal function impairments in whom further increase in Metformin dose is not recommended. page 7 / 7