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1 Clinical Trial Details (PDF Generation Date :- Sat, 15 Sep :09:24 GMT) CTRI Number CTRI/2009/091/ [Registered on: 04/06/2010] - Last Modified On 02/09/2014 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study No Interventional Drug Randomized, Parallel Group, Multiple Arm Trial Comparison of NN1250 with insulin glargine in type 2 diabetes A 26 week randomised, controlled, open label, multicentre, multinational, three-arm, treat to target trial comparing efficacy and safety of three different dosing regimens of either NN1250 or insulin glargine with or without combination with OAD treatment, in subjects with type 2 diabetes mellitus (BEGIN? : FLEX) 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) EudraCT NCT Designation Affiliation ClinicalTrials.gov Details of Principal Investigator Dr Nikhil Tandon Phone Fax Designation Affiliation Professor dept of endocrinology and metabolism All Sciences Room no.311, Biotechnology Block, Ansari Nagar, New Delhi DELHI nikhil_tandon@hotmail.com Details Contact Person (Scientific Query) Dr Raman Shetty Phone Fax Designation Affiliation Clinical,Medical and Regulatory Director Novo Nordisk Private Ltd. Plot No.32, 47-50,EPIP Area, Whitefield,Bangalore Bangalore KARNATAKA rasy@novonordisk.com Details Contact Person (Public Query) Mr Avik Kumar Ghosh Head Clinical Operations Manager Novo Nordisk Private Ltd. Novo Nordisk Private Ltd. Plot No.32, 47-50,EPIP Area, Whitefield,Bangalore Bangalore KARNATAKA page 1 / 6

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Phone Fax > Novo Nordisk A/S Type of Sponsor NIL List of Countries of Principal Investigator Dr. Prof. Debasish Maji Dr Bipin Kumar sethi Dr Subhankar Chowdhury Dr. P.V.Rao Dr. Harish Kumar Dr. Nihal Thomas Source of Monetary or Material Support Primary Sponsor Details Novo Nordisk AS c/onovo Nordisk Private Ltd. Plot No.32, 47-50, EPIP Area, Whitefield, Bangalore Pharmaceutical industry-global of Site Site Phone/Fax/ Calcutta Diabetes and Endocrine Foundation Consultant Endocrinologist Endocrinology Endocrinology & Metabolism, Nizam's Sciences, Endocrinology and Diabetes Amrita Sciences Calcutta Diabetes and Endocrine Foundation,Diabetes and Endocrine clinic 11/7A, J.K. Pal road Kolkata WEST BENGAL CARE Hospital, /1/1ª,,Banjara Hills Hyderabad ANDHRA PRADESH IPGME & R and SSKM Hospital Ronald Ross Building,4th Floor, Room No 8244, A J C BOSE Road Not Applicable N/A d.maji50@gmail.com bipinkumarsethi@yaho o.co.in Subhankar.chowdary@ gmail.com Endocrinology & Metabolism, Nizam's diabtrials@yahoo.co.in Scie nces,,panjagutta Hyderabad ANDHRA PRADESH Amritha lane,elamakkara P.O., Not Applicable N/A Endocrinology Christian Medical College Hospital Endocrinology Christian Medical College Hospital,Vellore Vellore harishkumar@aims.amr itha.edu nihal_thomas@yahoo.c om page 2 / 6

3 Details of Ethics Committee Dr.Nalini Shah Dr. Sunil M. Jain Dr. A. Ramachandran Dr. Ambrish Mithal Dr. Nikhil Tandon Dr Anil Bhansali Endocrinology, Diabetes Thyroid Hormone research Institute n Diabetes Research Foundation Indraprastha Apollo Hospitals Professor dept of endocrinology and metabolism Room No 3027,3rd floor, Research Block B TAMIL NADU KEM Hospital,,Parel Mumbai MAHARASHTRA Diabetes Thyroid Hormone research Institute,11/5 New Palasia, Near 56 Dukan, Indore MADHYA PRADESH No:-28, Marshall?s Road,Egmore Chennai TAMIL NADU Sarita Vihar, Delhi Mathura Road,, New Delhi DELHI Room no.311, Biotechnology Block,,Medical Sciences,Ansari Nagar, New Delhi DELHI Post Graduate Institute of Medical Education & Research, Chandigarh CHANDIGARH nalinishah@gmail.com sunilmjain@gmail.com ramachandran@ardiab etes.org ambrishmithal@hotmail.com nikhil_tandon@hotmail. com of Committee Approval Status Date of Approval Is Independent Ethics Committee? Apollo Hospitals Education and Research Foundation Basement Hostel Complex, Indraprasta Apollo hospitals, Saritha Vihar, New Delhi Committee for Evaluation of Protocols for Clinical Research "Bhooma No.7, 17 A cross, Malleswaram West" Bangalore Ethics committee for Research on Human Subjects, Seth GSMC and KEM Hospital, Parel, Mumbai Ethics Committee of Diabetes Thyroid Hormone Research Institute Pvt Ltd, 11/5, Not Applicable No Date Specified No Approved 10/11/2009 Yes Approved 15/12/2009 Yes Approved 29/09/2009 No page 3 / 6

4 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent New Palasia (After Chhappan Dukan Triangle, On Right Side), Indore (MP), Diabetes Research Foundation & Dr. A. Ramachandrans Diabetes Hospitals, No.28 Marshalls Road, Egmore. Chennai Institute Ethics Committee, All Sciences, Room No 102, 1st Floor Old OT Block, Ansari Nagar, New Delhi Institute Ethics Committee, Post Graduate Institute of Medical Education and Research, Chandigarh Committee, Amrita lane, AIMS,Ponekkara P O, Cochin Committee, Institute of Post Graduate Medical Education and Research, 244, AJC Bose Road, Kolkata-20 Committee, Nizam?s Sciences University, Panjagutta, Hyderabad Committee,CARE Hospital, Road No 1, Banjara Hills, Hyderabad , Institutional Review Board, Christian Medical College, Bagay am,vellore Status Approved 20/11/2009 No Approved 04/11/2012 No Approved 27/11/2009 No Approved 07/12/2009 No Approved 25/11/2009 No Not Applicable No Date Specified No Approved 18/10/2009 No Approved 16/11/2009 No Date Approved/Obtained 06/11/2009 Health Type Condition Patients Diabetes Mellitus, Type 2 Type Details Intervention NN1250 NN1250 injected s.c. (under the skin) once daily. The doses will page 4 / 6

5 Inclusion Criteria Exclusion Criteria Method of Generating Random Sequence Method of Concealment Blinding/Masking be individually adjusted Intervention NN1250 NN1250 injected s.c. (under the skin) once daily (alternative regimen). The doses will be individually adjusted. Comparator Agent Insulin Glargine Insulin glargine injected s.c. (under the skin) once daily.the dose will be individually adjusted Age From Age To Gender Details Details Year(s) Year(s) Both Computer generated randomization On-site computer system Open Label Inclusion Criteria Type 2 diabetes mellitus for at least 6 months Currently treated with oral antidiabetic drugs, treated with insulin or a combination of oral antidiabetic drugs and insulin for at least 3 months For patients currently treated with oral antidiabetic drug: HbA1c 7-11% For patients currently treated with insulin: HbA1c 7-10% Body Mass Index (BMI) below or equal to 40.0 kg/m2 Age 18 years and older Exclusion Criteria Use GLP-1 receptor agonist (exenatide, liraglutide), rosiglitazone, DPP-IV inhibitors, a-glucosidase-inhibitors within the last 3 months prior to trial start Cardiovascular disease, within the last 6 months Uncontrolled treated/untreated severe hypertension Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures Cancer and medical history of cancer hereof Primary Outcome Outcome Timepoints HbA1c change from baseline from baseline Secondary Outcome Outcome Timepoints 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 Hypoglycaemic episodes, plasma glucose profiles Total Sample Size=687 Sample Size from =143 02/12/ /11/2009 Years=0 Months=6 Days=0 Completed Completed 26 Weeks page 5 / 6

6 Powered by TCPDF ( PDF of Trial Trial () Publication Details Brief Summary Meneghini Luigi, Atkin Stephen L, Gough Stephen C L, Raz Itamar, Blonde Lawrence, Shestakova Marina, Bain Stephen, Johansen Thue, Begtrup Kamilla, Birkeland Kåre I. The Efficacy and Safety of Insulin Degludec Given in Variable Once-Daily Dosing Intervals Compared With Insulin Glargine and Insulin Degludec Dosed at the Same Time Daily: A 26-week, randomized, open-label, parallel-group, treat-to-target trial in people with type 2 diabetes. Diabetes care 2013; 36 (4): Meneghini L. Flexible Once-Daily Dosing of Insulin Degludec does not Compromise Glycemic Control or Safety Compared to Insulin Glargine Given Once Daily at the Same Time Each Day in People with Type 2 Diabetes. American Diabetes Association (ADA) 2011; This trial is conducted in Africa, Asia, Europe and South America. The aim of this clinical trial is to compare NN1250 with insulin glargine in patients with type 2 diabetes. has enrolled122 subjects has randomised on 30 Nov 2009 page 6 / 6