Clinical Trial Details (PDF Generation Date :- Sun, 10 Mar 2019 08:06:47 GMT) CTRI Number Last Modified On 13/11/2018 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2017/03/007979 [Registered on: 01/03/2017] - Trial Registered Prospectively No Interventional Drug Randomized, Parallel Group, Active Controlled Trial Safety Assessment of Lyxumia (Lixisenatide) and Sulfonylurea as Add-on Treatment to Basal Insulin in Uncontrolled Patients With Type 2 Diabetes Mellitus Who Elect to Fast During Ramadan (LixiRam) International, randomized, open label study to compare the safety and efficacy of lixisenatide vs sulfonylurea on top of basal insulin treatment in Type 2 Diabetes Mellitus subjects who elect to fast during Ramadan Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) LPS14410, Version No- 1, Dated-27-July-2016 Protocol Number Details of Principal Investigator Details Contact Person (Scientific Query) Details Contact Person (Public Query) Phone Fax Details Contact Person (Scientific Query) Sujeet Ojha Phone 022-28032805 Fax 022-28032841 Senior Clinical Project Leader Sanofi-Synthelabo () Private Limited Powai, 400 072 Sujeet.Ojha@sanofi.com Details Contact Person (Public Query) Sujeet Ojha Senior Clinical Project Leader Sanofi-Synthelabo () Private Limited Powai, Sanofi House, CTS No.117-B, L&T Business Park, Saki Vihar Road, Powai, 400 072 page 1 / 5
Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Phone 2228032841 Fax 02228032841 Sujeet.Ojha@sanofi.com > Sanofi-Synthelabo () Private Limited Type of Sponsor NIL List of Countries Israel Kuwait Lebanon Turkey of Principal Investigator Dr Arthur Joseph Asirvatham Dr Paramesh S Dr Kanajenahalli Narayanappa Satish Babu Source of Monetary or Material Support Primary Sponsor Details SanofiSynthelabo Private Limited Powai, Pharmaceutical industry-global NIL of Site Site Phone/Fax/ Arthur Asirvatham Diabetes Centre BGS Global s 42-A, Kuruvikkaran Salai, Anna Bus Stand, Madurai- 625 020 Madurai TAMIL NADU No. 426, 4th Cross, 2nd Block,Kalyan Nagar, - 560043, Karnataka, Endocrinology Department, BGS Health & Enducation City, #67, Uttarhalli Road, Kengeri,, Karnataka 560060, Dr Hemant Thacker Bhatia G1-Block (Ground Floor), Tardeo Road, - 400007 Dr Rajeswari Janakiraman Colombia Asia 26/4, Brigade Gateway, Besides Metro, Malleswaram West, - 560055, Karnataka, 0452-25355266 ajasirvathamresearch@ yahoo.in 09845010610 drparamesh2@gmail.co m 9731533636 babu09_uk@yahoo.co. uk 9820073882 drhpt@hotmail.com 8039898969 rajeswari.janakiraman@ colombiaasia.com Dr Parag Shah Dr. Jivraj Mehta Smarak Rataubhai Adani 9824042688 page 2 / 5
Details of Ethics Health Foundation & Bakeri Medical Arogyadham, Near Aay ojannagar,ahmedabad, 380007, Gujarat, Ahmadabad GUJARAT Dr Gupta Jugal Bihari Eternal 3A, Jagatpura Road, Near Jawahar Circle,Jaipur- 302017, Rajasthan, Jaipur RAJASTHAN Dr Alapati Lakshmi Lavanya Dr Paturi Vishnupriya Rao Global s Kumudini Devi Diabetes 6-1-1070 / 1 to 4, Lakdi- Ka- Pool, 500004, II Floor, Ramdevrao hospital Kukatpally, -500072 Dr Faraz Farishta Medwin Raghava Ratna Towers, Nampally, -500001, Andhra Pradesh, Dr Rakesh Kumar Sahay Dr Sunil Gupta Osmania General Sunils Diabetes care and Research centre Pvt. Ltd Department of Endocrinolgy, 2nd Floor, Golden Jubilee Block, Osmania General, Afzalgunj, -500012, Telangana, 42, Lendra Park, Ramdas Peth, Nagpur-440010, Maharashtra Nagpur paragendocrine@yahoo.com 9829414680 drjbgupta@gmail.com 9177539974 alapatil2000@yahoo.co m 9948145445 raopaturi@gmail.com 9885035977 drfarazfarishta@gmail.c om 9849597507 sahayrk@gmail.com 9823152111 drsgupta_ngp@rediffma il.com of Approval Status Date of Approval Is Independent Ethics? Clinical Trial Ethics -Bhatia Dr. Jivraj Mehta Smarak Health Foundation & Bakeri Medical Eternal Heart Care Centre & Research Institute-Institutional Ethics Approved 16/01/2017 No Approved 12/12/2016 No Approved 01/12/2016 No page 3 / 5
Ethics of Sunil Diabetes Care n, Nagpur Columbia Asia, Approved 19/01/2017 No Approved 23/12/2016 No Approved 11/11/2016 No RamdevRao, Medwin -Arthur Asirvatham -BGS Global s, -Global s Medisys Clinisearch Ethics Review Board Osmania Medical College Ethics Approved 27/01/2017 No Approved 21/12/2016 No Approved 02/12/2016 No Approved 22/12/2016 No Approved 28/12/2016 No Approved 26/11/2016 No Regulatory Clearance Status from DCGI Status Date Approved/Obtained 17/03/2017 Health Condition / Problems Studied Health Type Patients Patients Condition Type 2 Diabetes Mellitus Patients Type 2 diabetes mellitus without complications Intervention / Comparator Agent Type Details Intervention Lixisenatide 10mcg/20mcg subcutaneous injection for 12 to 20 weeks Comparator Agent Sulfonylurea Sulfonylurea will be prescribed by Investigators under their commercially available formulation and used according to labeling per country and guidelines. Patients randomized in control arm will continue the sulfonylurea taken prior to study. Oral-for 12 to 20 weeks Inclusion Criteria Age From Age To Gender Details 18.00 Year(s) 99.00 Year(s) Both Inclusion Criteria Patients with T2DM, For complete list of inclusion criteria, please contact sponsor Method of Generating Exclusion Criteria Computer generated randomization page 4 / 5
Powered by TCPDF (www.tcpdf.org) Random Sequence Method of Centralized Concealment Blinding/Masking Open Label Primary Outcome Outcome Timepoints Percentage (%) of patients with at least 1 documented symptomatic hypoglycemia event (plasma glucose?70 mg/dl; 3.9 mmol/l) during Ramadan fast (29-30 days; from start to end of Ramadan holy month) regardless of study treatment discontinuation and/or treatment intensification. 29-30 days; from start to end of Ramadan holy month Secondary Outcome Outcome Timepoints? Mean change in HbA1c from baseline to pre-ramadan visit and from baseline to post-ramadan visit? Mean change in body weight from baseline to pre-ramadan visit and from baseline to post-ramadan visit? Percentage of patients with 2hPPG 180 mg/dl (10 mmol/l)(mean SMPG levels 2 hours after IFTAR during the last 14 days of Ramadan? Percentage of patients with HbA1C 7% at pre-ramadan and post-ramadan visits? Percentage of patients with FPG 130 mg/dl (7.22 mmol/l) at pre-ramadan visit Target Sample Size Total Sample Size=236 Sample Size from =150 Phase of Trial Phase 4 Date of First 11/03/2017 Enrollment () Date of First 23/02/2017 Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Years=1 Months=0 Days=0 Completed Completed None yet This is an international, randomized, open label study to compare the safety and efficacy of lixisenatide vs sulfonylurea on top of basal insulin treatment in 236 patients with Type 2 Diabetes Mellitus who elect to fast during Ramadan, that will be conducted in 15 centers in. Globally around 7 countries will be participating. page 5 / 5