Clinical Trial Details (PDF Generation Date :- Fri, 19 Apr 2019 13:49:20 GMT) CTRI Number CTRI/2009/091/000126 [Registered on: 15/04/2009] - Last Modified On 03/09/2014 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study Interventional Drug Randomized, Parallel Group, Multiple Arm Trial Efficacy and Long-Term Safety of Vildagliptin as Add-on Therapy to Metformin in Patients With Type 2 Diabetes A multi-center, randomized, double-blind study to evaluate the efficacy and long-term safety of vildagliptin modified release (MR) as type 2 diabetes Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) CLAF237B2224 NCT00860288 Protocol Number ClinicalTrials.gov Details of Principal Investigator Not Applicable N/A Details Contact Person (Scientific Query) Details Contact Person (Public Query) Phone Fax Details Contact Person (Scientific Query) Dr. Kamala Rai Phone 022-24958533 Fax 24954112 Novartis Healthcare Private Limited, Medical Department, Sandoz House Shivsagar Estate, Dr. Annie Besant Road, Worli Mumbai MAHARASHTRA 400018 kamala.rai@novartis.com Details Contact Person (Public Query) Dr. Kamala Rai Phone 022-24958533 Novartis Healthcare Private Limited, Medical Department, Sandoz House Shivsagar Estate, Dr. Annie Besant Road, Worli Mumbai MAHARASHTRA 400018 page 1 / 5
Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Fax 24954112 kamala.rai@novartis.com Source of Monetary or Material Support > Novartis Pharma AG, Lichstrasse 35, 4056, Basel, Switzerland Type of Sponsor NIL List of Countries of Principal Investigator Dr. Nihal Thomas Dr. Sunil Jain Dr. Mathew Thomas Dr. Hemanga Barman Dr. K.M. Prassana Kumar Dr. V Mohan Primary Sponsor Details Novartis Healthcare Private Limited Medical Department, Sandoz house, shivsagar estate, Dr. Annie besant road, Worli, Mumbai 400018 Pharmaceutical industry-global of Site Site Phone/Fax/ Christian Medical college Diabetes Thyroid Hormone Research Institute Pvt Ltd Health and Research Centre M V Hospital for Diabetes M.S. Ramaiah Memorial hospital Madras Diabetes Research Foundation Department of 0416-4200844 Endocrinology,Diabetes and Metabolism.P.O Box. No. 3-632 004 Vellore 11/5,New Palasia (After 56 shop Triangle)-452001 Indore MADHYA PRADESH TC - 1 / 907, 1st floor,,devi Scans Building, Kumarapuram Medical college.p.o -695 001 Not Applicable N/A 4, west mada church street,royapuram-600 013 Chennai endocrinology dept, basement,m.s.r.i.t, post new bel road-560054 Bangalore KARNATAKA 4, Conran Smith Road,Gopalapuram-60 0 086 Chennai Dr. Mohan Badgandi Manipal Hospital 98 Rustom Bagh,Airport Road-560 017 Bangalore KARNATAKA 09926015638 9995126758 09884894576 +91 44 25954919 09920182263 0-9840134505 9844036500 Dr. Rakesh Sahay Mediciti Hospital 5-9-22,Secritariot 9985918187 page 2 / 5
Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Dr. Usha Rani Dr. J. B. Gupta Nizam?s institute of medical sciences S.R. Kalla Memorial gastro and general hospital Rd-500 036 Hyderabad ANDHRA PRADESH dept of pharmacology and therapeutics,punjagutta -500 082 Hyderabad ANDHRA PRADESH 78 dhuleshwar garden,,sardar patel marg, c-scheme-302001 Jaipur RAJASTHAN 0984918187 09414944938 of Committee Approval Status Date of Approval Is Independent Ethics Committee? Diabetes Research Centre Ethics Committee Ethics Committee of Manipal Hospital & Manipal Heart Foundation DTHRI Mediciti Hospitals Nizams Institute Of Medical Sciences Independent Human Health And Research Centre Institutional Ethics Committee, Madras Diabetes Research Foundation Approved 27/01/2009 No Approved 16/01/2009 No Approved 21/12/2008 No Approved 04/02/2009 No Approved 02/01/2009 No Approved 09/01/2009 Yes Approved 12/11/2008 No Institutional Review Approved 19/01/2009 No Board Christian Medical College M.S.RAmiah Medical College And Teaching Hospital Ethical Review Board S.R.Kalla Memorial Ethical Committee for Human Research Status Approved 13/01/2009 No Approved 10/11/2008 No Date Approved/Obtained 02/01/2009 Health Type Patients Condition Type 2 Diabetes Mellitus Type Details Intervention vildagliptin MR 25 mg tablets page 3 / 5
Inclusion Criteria Exclusion Criteria Method of Generating Random Sequence Method of Concealment Blinding/Masking Intervention vildagliptin MR 12.5 mg tablets Comparator Agent Placebo vildagliptin MR 25 mg matching placebo tablets Comparator Agent Placebo Sitagliptin 50 mg matching placebo capsules Comparator Agent Sitagliptin 50 mg capsules Comparator Agent Placebo vildagliptin MR 12.5 mg matching placebo tablets Age From Age To Gender Details Inclusion Criteria? Patients 18-78 years old inclusive at Visit 1? T2DM patients treated with metformin for at least 3 months and a stable dose of at least 1500 mg daily for a minimum of 4 weeks prior to Visit? Patient agreement to maintain same dose of metformin throughout study? HbA1c of 7.0 and 9.5 % at Visit 1? Body Mass Index (BMI) in the range of 22-45 kg/m2 at visit 1 Exclusion Criteria Details? Pregnant or nursing (lactating) women? FPG 270 mg/dl ( 15.0 mmol/l) Computer generated randomization Centralized Participant, Investigator and Outcome Assessor Blinded Primary Outcome Outcome Timepoints? To evaluate the efficacy of vildagliptin as T2DM by assessing changes in HbA1c with vildagliptin added to metformin to that of placebo added to metformin after 24 weeks of treatment [ Time Frame: 24 weeks ] [ Designated as safety issue: No ] Secondary Outcome Outcome Timepoints? To evaluate the efficacy of vildagliptin as T2DM by assessing changes in HbA1c with vildagliptin added to metformin to that of sitagliptin added to metformin after 24 weeks of treatment. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]? To evaluate the efficacy of vildagliptin as add-on therapy to metformin in patients with T2DM by assessing changes in fasting plasma glucose with vildagliptin added to metformin to that of placebo added to metformin after 24 weeks of treatment. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]? To evaluate the efficacy of vildagliptin as add-on therapy to metformin in patients with T2DM by assessing changes in fasting plasma glucose with vildagliptin added to metformin to that of sitagliptin added to metformin. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]? To evaluate page 4 / 5
Powered by TCPDF (www.tcpdf.org) Target Sample Size the long-term efficacy of vildagliptin compared to sitagliptin over the entire study duration as T2DM. [ Time Frame: 76 weeks ] [ Designated as safety issue: No ]? To evaluate the long-term safety and tolerability of vildagliptin compared to sitagliptin over the entire study duration as T2DM. [ Time Frame: 76 weeks ] [ Designated as safety issue: Yes ]? To evaluate the body weight change from baseline with vildagliptin compared to placebo and sitagliptin after 24 weeks of treatment as add-on therapy to metformin in patients with T2DM. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]? To evaluate the safety and tolerability of vildagliptin compared to placebo and sitagliptin over 24 weeks of treatment as add-on therapy to metformin in patients with T2DM. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ] Total Sample Size=0 Sample Size from = Phase of Trial Phase 2/ 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 No Date Specified 12/03/2009 Years=2 Months=1 Days=0 Completed Completed Brief Summary Patients target from is 200. page 5 / 5