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1 Clinical Trial Details (PDF Generation Date :- Sun, 26 v :12:26 GMT) CTRI Number Last Modified On 08/08/2017 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2017/01/ [Registered on: 06/01/2017] - Trial Registered Prospectively Interventional Drug Randomized, Parallel Group, Active Controlled Trial Safety and Efficacy of Fixed Dose Combinations of Repaglinide and Voglibose tablets in Patients with Type 2 Diabetes Mellitus A Multicentric, Randomized, Open Label, Comparative, Parallel assignment Clinical Trial to Evaluate the Safety and Efficacy of Fixed Dose Combinations (FDC) of Repaglinide (0.5mg / 1mg) + Voglibose (0.2mg / 0.3mg) tablets Versus Repaglinide (0.5mg / 1mg) tablets in Patients with Type 2 Diabetes Mellitus 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) CT/REPA VOGL/DIA/14 Version 2.1 dated 02/07/16 Designation Affiliation Protocol Number Details of Principal Investigator Dr Sushil Kumar Anand Assistant General Manager Torrent Pharmaceuticals Ltd, Torrent Research Centre Address Torrent Pharmaceuticals Ltd, Research centre, Village: bhat Dist: gandhinagar, gujarat Gandhinagar Phone Fax Designation Affiliation sushilkumaranand@torrentpharma.com Details Contact Person (Scientific Query) Dr Sushil Kumar Anand Assistant General Manager Torrent Pharmaceuticals Ltd, Torrent Research Centre Address Torrent Pharmaceuticals Ltd, Research centre, Village: bhat Dist: gandhinagar, gujarat Gandhinagar Phone Fax Designation Affiliation sushilkumaranand@torrentpharma.com Details Contact Person (Public Query) Dr Sushil Kumar Anand Assistant General Manager Torrent Pharmaceuticals Ltd, Torrent Research Centre Address Torrent Pharmaceuticals Ltd, Research centre, Village: bhat Dist: gandhinagar, gujarat Gandhinagar page 1 / 7

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Phone Fax > Torrent Pharamceutical Ltd., Source of Monetary or Material Support Primary Sponsor Details Torrent Pharamceutical Ltd Address Torrent Pharamceutical Ltd, Research Centre, Village Bhat Dist- Gandhinagar, Gujarat, Type of Sponsor NIL List of Countries of Principal Investigator Dr Bhagirath Solanki Pharmaceutical industry-n Address NIL of Site Site Address Phone/Fax/ B. J. Medical College and Civil Hospital Dr Shashank Passwala BAPS Pramukhswami Hospital B. J. Medical College and Civil Hospital, Asarwa Ahmedabad , Gujarat Ahmadabad Adajan Cross Road, Adajan, Surat , Gujarat Surat Dr Binayak Sinha Fortis Hospital Fortis Hospital, 730 Anandapur, Kolkata ,West Bengal, Kolkata WEST BENGAL Dr Thrilok Chander Dr Pankaj Akholkar Gandhi Medical College and Hospital, Secunderabad GMERS Medical College, Sola Civil Hospital, Gandhi Medical College and Hospital, Musheerabad, Secunderabad , Telangana Rangareddi ANDHRA PRADESH GMERS Medical College, Sola Civil Hospital, Medicine Department, S G Higway, Nr. Gujarat Highcourt, Ahmedabad Gujarat Ahmadabad drbhagirath@yahoo.co.i n spasswala@yahoo.com binayak.sinha@gmail.c om thrilok73@gmail.com drpankaj_md@yahoo.c om Dr Neeraj Manikanth Government Medical Government Medical page 2 / 7

3 Details of Ethics Committee Dr M Jaiganesh Dr Kamal Nahata Dr Srinivasa M Dr Sanjay Bhadada Dr Parmendra Sirohi Dr Sunil Kumar Dhand Dr Pooja Khosla College, Kozhikode M V Hospital for Diabetes Private Ltd Marwari Hospital & Research Centre, Guwahati Mysore Medical College and Research Institute, K R Hospital Nehru Hospital, Post Graduate Institute of Medical Education and Research, Chandigarh S.P Medical College & A G of Hospitals Shri Nidaan Hospital & Hope Fertility Center, Jaipur Sir Ganga Ram Hospital, New Delhi College, Kozhikode , Kerala. Kozhikode KERALA nmanikath@gmail.com M V Hospital for Diabetes Private Ltd, #4 West Mada Church jaiganeshat@yahoo.co.i Street, Royapuram, n Chennai , Tamilnadu Chennai TAMIL NADU Marwari Hospital & Research Centre, S. J Road, Athgaon, Guwahati, , Assam Kamrup ASSAM Mysore Medical College and Research Institute, K R Hospital, Irwin Road, Mysore Mysore KARNATAKA kamalnahata@gmail.co m drsrinivasam@gmail.co m Department of Endocrinology,Nehru Hospital, Post Graduate bhadadask@rediffmail. Institute of Medical com Education and Research (PGIMER), Chandigarh Chandigarh CHANDIGARH S.P Medical College & A G of Hospitals, Bikaner , Rajasthan Bikaner RAJASTHAN Shri Nidaan Hospital & Hope Fertility Center, 27- Vidhyot Nagar-A, Ajmer Road, Jaipur , Rajasthan Jaipur RAJASTHAN Sir Ganga Ram Hospital, Sir Ganga Ram Marg, Rajinder nagar, New Delhi New Delhi DELHI psirohi@gmail.com drsdhand@gmail.com poojakhosla@hotmail.c om of Committee Approval Status Date of Approval Is Independent Ethics Committee? page 3 / 7

4 Ethics commitee of Vishwanathan Diabetes Research Centre M.V. Hospital for Diabetes Ltd Ethics commitee, GMERS Medical College, Sola, Ahmedabad, Gujarat Ethics Committee, & Research Centre- Hospital Ethics Committee, Marwari Hospital and Research Centre, Guwahati Ethics committee, BAPS Pramukh Swami Hospital, Adajan Cross Road, Adajan, Surat , Gujarat Ethics Committee, Government Medical College, Kozhikode Ethics Committee, S.P Medical College & A G of Hospitals, HRMC Cardiovascular Science and Research, Bikaner Ethics Committee, Sir Ganga Ram Hospital Ethics Committee,New Delhi Ethics committee, Swastic Ethics Committee, 27- Vidhut Nagar-A, Ajmer Road, Jaipur Institute Ethics Committee, B. J. Medical College & Civil Hospital- Ahmedabad Institutional Ethics Committee, Fortis Hospital, Kolkata Approved 17/12/2016 Date Specified Date Specified Approved 28/10/2016 Institutional Ethics Committee, Gandhi Medical College and Hospital, Secunderabad Institutional Ethics Committee, Mysore Medical College and Research Institute, K R Hospital and Associated Hospitals Institutional Ethics Committee, PGIMER, Chandigarh Date Specified Approved 26/12/2016 Approved 14/12/2016 Approved 24/09/2016 Approved 17/02/2017 Approved 02/05/2017 Date Specified Date Specified Approved 09/09/2016 page 4 / 7

5 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Status Date Approved/Obtained 16/06/2016 Health Type Patients Condition Type 2 Diabetes Patients Type Details Comparator Agent Intervention Age From Age To Gender Details Repaglinide 0.5mg and 1.0mg Tablets [1]. FDC of Repaglinide (0.5mg) & Voglibose (0.2mg) tablet [2]. FDC of Repaglinide (1.0mg) & Voglibose (0.2 mg)tablet [3]. FDC of Repaglinide (0.5mg) & Voglibose (0.3mg)tablet [4]. FDC of Repaglinide (1.0 mg) & Voglibose (0.3mg) tablet Year(s) Year(s) Both Inclusion Criteria 3 times a day orally, within 15 minutes prior to the meal. Patients will be instructed to skip a dose in case of skipped meal. 3 times a day orally, within 15 minutes prior to the meal. Patients will be instructed to skip a dose in case of skipped meal 1.Patients aged between 18 to 65 (both inclusive) years with diagnosis of Type 2 diabetes mellitus. 2.Patients who are inadequately controlled (HbA1C? 7.0%) with metformin monotherapy at maximum tolerable stable dose (not less than 1000mg/day) for at least 1 month prior to screening. 3.Patients who have 2hr Post Prandial Glucose? 200mg/dl at screening visit. 4.Patients willing to give informed consent Exclusion Criteria Details Exclusion Criteria 1.Patients with Insulin Dependent Diabetes Mellitus (IDDM). 2.Patients with Fasting Plasma Glucose (FPG)? 200 mg/dl and/or Glycosylated Hemoglobin (HbA1C)? 9%. 3.Patients requires frequent insulin for adequate glycemic control 4.Patients with history of treatment failure or intolerance or hypersensitivity with meglitinides and/or alpha-glucosidase inhibitors. 5.Patients with history of acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. 6.Patients with history of inflammatory bowel disease, colonic ulcerations or intestinal obstructions. 7.Patients who are known seropositive cases of HIV, Hepatatis B or Hepatitis C. 8.Patients with clinically significant impaired renal or hepatic function. [Aspartate aminotransferase (AST) & Alanine transaminase(alt) more than 2.5X the UNL and/or bilirubin more than 1.5X the UNL and/or serum creatinine >1.5 mg/dl.] 9.Patients planning to undergo any surgical procedure during their participation in the study (except minor procedures not associated with restricted intake of food and fluids). 10.History of malignancy in last 5 years. 11.Patients with history of alcohol or drug abuse. 12.Clinically Significant abnormal physical, laboratory, ECG findings and/or any other clinical condition or history at the screening examination, which would interfere with the study objectives. page 5 / 7

6 13.Patients on any medications (other than metformin) which may interfere with study outcome. 14.History of angina, Myocardial Infarction (MI) or stroke within last 6 months prior to screening. 15.Pregnant or lactating women. 16.Female patients who are of childbearing potential and who are neither surgically sterilized nor willing to use reliable contraceptive methods (like hormonal, barrier methods or intrauterine device) 17.Intake of any investigational drug within 3 months prior to the first dose of study drug 18.In the opinion of the investigator, patient is unable to cooperate with any study procedures, unlikely to adhere to the study protocol, keep appointments, or is planning to relocate during the study. Method of Generating Random Sequence Method of Concealment Blinding/Masking Permuted block randomization, fixed Centralized Open Label Primary Outcome Outcome Timepoints Mean change in glycosylated hemoglobin (HbA1C) from baseline (screening) to end of treatment period. Week 0, Week 12, Week 24 Secondary Outcome Outcome Timepoints 1.Mean change in fasting plasma glucose (FPG) from baseline (screening) to end of treatment period. 2.Mean change in 2-hr post prandial plasma glucose (PPG) from baseline (screening) to end of treatment period. Week 0, Week 2, Week 4, Week 8, Week 12, Week 18 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=210 Sample Size from =210 16/01/2017 Date Specified Years=1 Months=0 Days=0 t Applicable t Yet Recruiting Nil Type 2 diabetes is a chronic, progressive metabolic disease defined by the presence of chronic hyperglycemia. To overcome high failure rate of long-term monotherapy and progression of vascular complications developed due to postprandial glucose excursions, a combined therapy of oral antidiabetic agents with complementary modes of action should be considered. Because of their complementary mechanism of actions, combination therapy with non-sulfonylurea insulin secretagogue (repaglinide) with alpha -glucosidase inhibitor (voglibose) will will have synergistic action in patient with post prandial hyperglycemia. Considering this Phase III clinical trial has been planned to evaluate safety and page 6 / 7

7 Powered by TCPDF ( REF/2016/08/ efficacy of fixed dose combinations of Repaglinide + Voglibose in patients with type 2 diabetes. page 7 / 7

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