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1 Clinical Trial Details (PDF Generation Date :- Tue, 09 Apr :50:06 GMT) CTRI Number Last Modified On 06/06/2016 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2011/05/ [Registered on: 10/05/2011] - Trial Registered Prospectively No Interventional Drug Randomized, Parallel Group, Multiple Arm Trial BI add-on to Usual Care Compared With Usual Care Alone in Patients With Type 2 Diabetes Mellitus at High Cardiovascular Risk A Phase III, multicentre,international, randomised, parallel group, double blind cardiovascular safety study of BI (10 mg and 25 mg administered orally once daily) compared to usual care in type 2 diabetes mellitus patients with increased cardiovascular risk 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) Protocol Number NCT Designation Affiliation ClinicalTrials.gov Details of Principal Investigator Sandeep Nair Project Manager - Clinical Operations Sponsor Phone Fax Designation Affiliation Boehringer Ingelheim Pvt. Ltd., 1102, 11th Floor, Hallmark Business Plaza Guru Nanak Hospital Road, Near Guru Nanak Hospital, Bandra (East) Mumbai Mumbai sandeep.nair@boehringer-ingelheim.com Details Contact Person (Scientific Query) Sandeep Nair Project Manager - Clinical Operations Sponsor Phone Fax Designation Affiliation Boehringer Ingelheim Pvt. Ltd., 1102, 11th Floor, Hallmark Business Plaza Guru Nanak Hospital Road, Near Guru Nanak Hospital, Bandra (East) Mumbai Mumbai sandeep.nair@boehringer-ingelheim.com Details Contact Person (Public Query) Dr Partha Gokhale Head Clinical Operations Sponsor Hallmark Business Plaza Guru Nanak Hospital Road, Near Guru Nanak Hospital, Bandra (East) Mumbai page 1 / 8

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Mumbai Phone Fax > Boehringer Ingelheim Pharmaceuticals Type of Sponsor Boehringer Ingelheim Pharmaceuticals List of Countries Argentina Austria Belgium Brazil Canada Colombia Croatia Denmark France Georgia Greece Hungary Israel Italy Malaysia Mexico Netherlands Norway Peru Philippines Poland Portugal Republic of Korea Romania Russian Federation South Africa Spain Sri Lanka Source of Monetary or Material Support Primary Sponsor Details Boehringer Ingelheim Pharmaceuticals Boehringer Ingelheim Pvt Ltd, 11th Floor Hallmark Plaza, Near Guru Nanak Hospital, Bandra East, Mumbai Pharmaceutical industry-global Boehringer Ingelheim Pvt Ltd, 11th Floor Hallmark Plaza, Near Guru Nanak Hospital, Bandra East, Mumbai page 2 / 8

3 Sites of Study Switzerland Taiwan Thailand Ukraine United Kingdom United States of America of Principal Investigator of Site Site Phone/Fax/ Paramesh Shamanna Bangalore Clinisearch No 416,4th Cross,2nd Block,Kalyan Nagar,Ba ngalore KARNATAKA, INDIA Bangalore KARNATAKA Dr Avinash Kulkarni Dr Sunil Gupta Dr S R Aravind Dr V Mohan Dr Krishna Mohan Gutlapalli Dr Ajay Kumar Pandey Dr Rajendrakumar Jain Deendayal Memorial Hospital Diabetes Care n Private Limited DIACON Hosiptal (Diabetes Care and ) Dr Mohans Diabetes Speciality Centre Dr. Ramesh Cardiac and Multispecialty Hospital Ltd Heritage Hospitals Limited Krishna Institute of Medical Sciences Deendayal Memorial Hospital, F. C. Road, Shivajinagar, Pune Pune 42, Lendra Park, Ramdaspeth, Nagpur , Maharashtra. Nagpur , 19th Main, 1st Block, Rajajinagar, Bangalore Bangalore KARNATAKA Dr Mohans Diabetes Specialities Centre, No- 6B, Conran Smith Road, Gopalapuram, Chennai Chennai TAMIL NADU Dr. Ramesh Cardiac and Multispecialty Hospital Ltd, Ring Road, Near ITI College, Vijaywada , Andhra Pradesh Krishna ANDHRA PRADESH Lanka, Varanasi Varanasi UTTAR PRADESH Krishna Institute of Medical Sciences /1, Minister Road, Secunderabad AP, INDIA. Hyderabad ANDHRA PRADESH drparamesh2@gmail.co m adkul@hotmail.com drsgupta-ngp@rediffma il.com draravind@hotmail.com drmohans@vsnl.net krishnagutlapalli@gmail.com kumarpre@hotmail.com page 3 / 8

4 Dr Mini Gangadharan Pillai Lakshmi Hospital Lakshmi Hospital, Diwans Road, Ernakulam, Cochin , Kerala, Ernakulam KERALA Dr Mohan Badgandi Manipal Hospital Manipal Hospital, No 98, Opp Hotel Leela Palace, Rustum Bagh RD, Airport Road, Bangalore Bangalore KARNATAKA Dr Jugal Bihari Gupta Dr Nitin Ghaisas Dr Nehal Sadhu Dr Niteen Deshpande Dr Ganapathi Bantwal S R. Kalla Memorial Gastro and General Hospital S R Kalla Memorial Gastro and General Hospital, 78 Dhuleshwar Gardens Behind HSBC Bank, Sardar Patel Marg, C- Scheme, Jaipur Jaipur RAJASTHAN Shatabdi Shatabdi Superspeciality Hospital Superspeciality Hospital, Suyojit City Centre, Mumbai Naka, Opposite Mahamarg Bus Stand, Nasik Nashik Shree Krishna Hospital and Heart Care Centre Spandan Heart Institute and St. John Medical College and Hospital Shree Krishna Hospital and Heart Care Centre D-1, Block Shantiniketan Apartment, Opposite H B Kapadiya School, Gurukul Road, Memnagar, Ahmedabad Ahmadabad GUJARAT Spandan Heart Institute and, 31, off Chitale Marg, Dhantoli, Nagpur Nagpur St. John Medical College and Hospital, Sarjapur Road, Koramangala, Bangalore , Karnataka Bangalore KARNATAKA minigpcrlk@gmail.com mohan.badgandi@mani palhospital.com drjbgupta@gmail.com nitin.ghaisas@gmail.co m drnehalsadhu@yahoo.c om nvdesh@hotmail.com mallyaganapathi@rediff mail.com page 4 / 8

5 Details of Ethics Committee Dr SivaKumar Reddy Sumana Hospital Sumana Hospital, Vivekananda Nagar Colony, Kukatpally Hyderabad Hyderabad ANDHRA PRADESH Dr Nitish Garg Dr Sunil M Jain Tagore Hospital and Heart Care Centre TOTALL Diabetes Hormone Institute Tagore Hospital and Heart Care Centre, Banda Bahadur Nagar, Mahavir Marg, Jalandhar Jalandhar PUNJAB A unit of Diabetes Thyroid Hormone Research Institute Pvt Ltd BCM Health Island, PU4, Scheme 54, Behind Prestige Management Institute, Near Bombay Hospital, Indore Indore MADHYA PRADESH siddamskreddy1@yaho o.co.in drnitishgarg@gmail.co m sunilmjain@gmail.com of Committee Approval Status Date of Approval Is Independent Ethics Committee? Bangalore Central Diacon Hospital, Ethics Committee Ethical Committee-Spandan Heart Institute and of Biniwale Clinic of Diabetes Care n, Diabetes Thyroid Hormone Research Institute Pvt. Ltd. Ethics Committee-Tagore Heart Care and Hyderabad Central Insitutional Ethics Commitee, Manipal Health Enterprises Private Limited Institutional Ethics Committee for Human Research at Heritage Hospitals Limited Approved 14/06/2011 Yes Approved 17/05/2011 No Approved 18/02/2011 No Approved 03/02/2011 No Approved 28/09/2011 No Approved 17/05/2011 No Approved 15/02/2011 No Approved 15/02/2011 Yes Approved 14/07/2011 No Approved 24/08/2011 Yes page 5 / 8

6 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Institutional Ethics Approved 13/04/2011 No Committee, Citi Cardiac Institutional Ethics Committee, Lakshmi Hospital Institutional Ethics Committee, Madras Diabetic Research Foundation KIMS Institutional Manav Independent S.R.Kalla Memorial Ethical Committee for Human Research Shatabdi Hospital ST. John s Medical College & Hospital Institutional Ethical Review Board Status Approved 19/03/2011 No Approved 22/03/2011 No Approved 24/10/2011 No Approved 23/02/2011 Yes Approved 07/02/2011 No Approved 14/02/2011 No Approved 22/03/2011 No Date Approved/Obtained 27/04/2011 Health Type Patients Condition Diabetes Mellitus, Type 2; Cardiovascular Risk Type Details Intervention BI mg, Once Daily, Orally till end of study period Intervention BI mg, Once Daily, Orally till end of study period Comparator Agent Placebo 10 mg or 25 mg, Once Daily, Orally till end of study period Age From Age To Gender Details Year(s) Year(s) Both Inclusion Criteria 1. Diagnosis of type 2 diabetes mellitus prior to informed consent 2. Male and female patients on diet and exercise regimen who are drug-nae or pre-treated with any background therapy. 3. HbA1c of?7.0% and? 10% for patients on background therapy or HbA1c?7.0% and?8.0% for drug-nae patients. 4. Age?18 years and? 65 years 5. BMI?45 kg/m2 (Body Mass Index) at Visit 1 (Screening) 6. Signed and dated written informed consent by date of Visit 1 in accordance with GCP and local legislation 7. In addition to the above described criteria, patients must have high cardiovascular risk, defined as at least one of the following: History of myocardial infarction (2 months prior to informed consent) Unstable angina (2 months prior informed consent) with documented multivessel coronary disease (of at least two major coronary arteries in angiogram) or positive stress test (ST segment page 6 / 8

7 Exclusion Criteria depression?2 mm or a positive nuclear perfusion scintigram). Multivessel Percutaneous Coronary Intervention (PCI) 2 months prior informed consent Multivessel Coronary Artery By-pass Grafting (CABG) 4 years prior to informed consent or with recurrent angina following surgery History of ischemic or hemorrhagic stroke (2 months prior to informed consent) Peripheral occlusive arterial disease (previous limb bypass surgery or percutaneous transluminal angioplasty; previous limb or foot amputation due to circulatory insufficiency, angiographic or ultrasound detected significant vessel stenosis (50% stenosis) of major limb arteries) Exclusion Criteria Details 1. Uncontrolled hyperglycaemia with a glucose level 240 mg/dl (13.3 mmol/l) after an overnight fast during placebo run-in and confirmed by a second measurement (not on the same day) 2. Indication of liver disease, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined during screening and/or run in phase. 3. Planned cardiac surgery or angioplasty within 3 months 4. Impaired renal function, defined as GFR30 ml/min (severe renal impairment, MDRD formula) as determined during screening and/or run in phase. 5. Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption 6. Blood dyscrasias or any disorders causing haemolysis or unstable Red Blood Cell (e.g. malaria, babesiosis, haemolytic anemia) 7. Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years 8. Contraindications to background therapy according to the local label 9. Treatment with anti-obesity drugs (e.g., sibutramine, orlistat) 3 months prior to informed consent or any other treatment at the time of screening (i.e., surgery, aggressive diet regimen, etc.) leading to unstable body weight 10. Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except T2DM 11. Pre-menopausal women (last menstruation? 1 year prior to informed consent) who: - are nursing or pregnant or - are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence (if allowed by local Authorities), double barrier method and vasectomised partner 12. Alcohol or drug abuse within the 3 months prior to informed consent that would interfere page 7 / 8

8 Powered by TCPDF ( Method of Generating Random Sequence Method of Concealment Blinding/Masking Stratified block randomization Centralized Double Blind Double Dummy with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake 13. Participation in another trial with an investigational drug within 30 days prior to informed consent 14. Any other clinical condition that would jeopardize patients safety while participating in this clinical trial Primary Outcome Outcome Timepoints The primary endpoint is time to the first occurrence of any of the following adjudicated components of the primary composite endpoint: CV death (including fatal stroke and fatal MI), non-fatal MI and non-fatal stroke. 4.5 years 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 Trial () Publication Details The composite of all events adjudicated: cardiovascular death (including fatal stroke and fatal myocardial infarction), non-fatal myocardial infarction, non-fatal stroke and hospitalization for unstable angina pectoris. To determine the incidence of microalbuminuria and the progression of microalbuminuria to macroalbuminuria from baseline to end of trial. To determine the incidence of silent MI Total Sample Size=4000 Sample Size from =300 10/05/ /08/2010 Years=4 Months=6 Days=0 Completed Completed NA 4 years 4 years 4 years Brief Summary The objective of the current study is to demonstrate non inferiority of two doses of BI (10 mg/daily and 25 mg/daily) compared to placebo with respect to first occurrence of any of the adjudicated components of the primary composite Major Adverse Cardiovascular Event endpoint (cardiovascular death, non fatal stroke, nonfatal myocardial infarction) in patients with type 2 diabetes mellitus and increased cardiovascular risk. Approximately 300 patients would be recruited in from 20 sites. The first patient from is expected to be screened on 10 May page 8 / 8