CTRI

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CTRI Number

CTRI/2010/091/000046 [Registered on: 05/02/2010]

Last Modified On:

26/03/2014

Post Graduate Thesis

Type of Trial

Interventional

Type of Study
Modification(s)

Drug

Study Design

Randomized, Parallel Group, Placebo Controlled Trial

Public Title of Study
Modification(s)

Cardiovascular Outcomes Study of Alogliptin in Subjects With Type 2 Diabetes and Acute Coronary Syndrome (EXAMINE)

Scientific Title of Study
Modification(s)

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Cardiovascular Outcomes Following Treatment with Alogliptin in Addition to Standard of Care in Subjects with Type 2 Diabetes and Acute Coronary Syndrome.

Trial Acronym

NIL

Secondary IDs if Any
Modification(s)

Secondary ID	Identifier
09/H0709/63	Other
2009-011222-34	EudraCT
2009-011222-34	Other
DOH-27-0310-3047	Other
JapicCTI-101246	Other
NCT00968708	ClinicalTrials.gov
SYR-322_402	Protocol Number
U1111-1111-6825	UTN

Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)

Name
Designation
Affiliation
Address
Phone
Fax
Email

Details of Contact Person
Scientific Query
Modification(s)

Name	Dr Shubhangi Desai
Designation	Associate Director, Clinical Project Management
Affiliation	SIRO Clinpharm Pvt. Ltd.
Address	Head Clinical Operations - Asia Pacific SIRO Clinpharm Pvt. Ltd. DIL Complex, II Floor, S.V. Road, Nr. Tatwagyan Vidyapeeth, Ghodbunder Road Thane MAHARASHTRA 400 610 India
Phone	02225848000
Fax	02225848275
Email	shubhangi.desai@siroclinpharm.com

Details of Contact Person
Public Query
Modification(s)

Name	Dr Shubhangi Desai
Designation	Head Clinical Operations - Asia Pacific
Affiliation	SIRO Clinpharm Pvt. Ltd.
Address	SIRO Clinpharm Pvt. Ltd. DIL Complex, II Floor, S.V. Road, Nr. Tatwagyan Vidyapeeth, Ghodbunder Road Thane MAHARASHTRA 400 610 India
Phone	02225848000
Fax	02225848275
Email	shubhangi.desai@siroclinpharm.com

Source of Monetary or Material Support
Modification(s)

NIL

Primary Sponsor
Modification(s)

Name	Takeda Global Research Development Center Europe Ltd
Address	61 Aldwych, London WC2B 4AE
Type of Sponsor	Pharmaceutical industry-Global

Details of Secondary Sponsor
Modification(s)

Name	Address
NIL

Countries of Recruitment
Modification(s)

Argentina
Australia
Belgium
Brazil
Bulgaria
Chile
Costa Rica
Czech Republic
Denmark
France
Germany
Guatemala
Hungary
India
Israel
Italy
Malaysia
Mexico
Netherlands
New Zealand
Other
Panama
Peru
Philippines
Poland
Portugal
Qatar
Republic of Korea
Romania
Russian Federation
Saudi Arabia
Serbia
Slovakia
South Africa
Spain
Sweden
Taiwan
Thailand
Turkey
Ukraine
United Kingdom
United States of America
Uruguay
Austria
Canada
Colombia
Croatia
Egypt
Finland
Greece
Hong Kong
Japan
Kuwait
Latvia
Lithuania
United Arab Emirates

Sites of Study
Modification(s)

No of Sites = 54
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Ramaiah Purushotham	A J Hospital and Research Centre	NH â€“ 17, Kuntikana , Mangalore, Karnataka, 575004. Dakshina Kannada KARNATAKA	0824-221-2290 mcrfmangalore@hotmail.com
Dr Algarsamy Mathavan	Apollo Speciality Hospitals	Lake View Road, K.K. Nagar, Madurai, Tamil Nadu- 625020 Madurai TAMIL NADU	0452-258-1157 cardio_madhav@hotmail.com
Dr Jaspal Arneja	Arneja Heart Institute	123, Ramadaspeth, Behind Sowalwar High School, Nagpur-440010 Nagpur MAHARASHTRA	07122448721 jaspalarneja_200@yahoo.com
Dr Atul Abhyankar	B D Mehta Mahavir Heart Institute	B. D Mehta Mahavir Heart Institute, Athwagute, Ring Road, Surat-395001 Surat GUJARAT	2612462116 atulda@hotmail.com
Dr Darshan Banker	Bankers Heart Institute	Near Tagore Nagar, Opp Suryakiran Building, Vadodara-390 015 Vadodara GUJARAT	02652324004 info@bankersheart.com
Dr Parvinder Singh	Baroda Heart Institute and Research Centre	44 Haribhakti Colony, Old Padra Road, Vadodara, Gujarat- 390007 Vadodara GUJARAT	0265-2351091 parvindar@yahoo.com
Dr Neeta Deshpande	Belgaum Diabetes Centre	Near Mahila Bhandar, Ground floor, Maruti Galli, Belgaum - 590001 Belgaum KARNATAKA	9880271313 neetarohit@gmail.com
Dr SS Ramesh	Bhagwan Mahaveer Jain Heart Centre	Miller’s Road, Vasanth Nagar, Bangalore - 560052 Bangalore KARNATAKA	08041999329 ssramesh@vivushealth.net
Dr Hemant Thacker	Bhatia Hospital	Bhatia Hospital, G-1 ward, Tardeo Road, Tardeo Mumbai-400007 Mumbai MAHARASHTRA	02223672358 drhpt@hotmail.com
Dr Srinivas Raju	Bollineni Superspeciality Hospital	Dargamitta, Nellore - 524003 Nellore ANDHRA PRADESH	0861-2312777 cssraju_66@yahoo.co.in
Dr Bhagavatula Kutumba Sastry	Care Hospital	Mozam Zahi Market Exhibition Road, Nampally, Hyderabad-500 001 Hyderabad ANDHRA PRADESH	04024745110 bkssastry@hotmail.com
Dr Bhaskara Rao	Care Hospital	10 50 11 5 Waltair Main Road, Ramnagar, Visakhapatnam-530 003 Visakhapatnam ANDHRA PRADESH	08916617791 bhaskarstudies@hotmail.com
Dr Manoj B Chopda	Chopda Medicare and Research Centre Pvt. Ltd.	Magnum Heart Institute, plot 3/5 Patil Lane no. 1, Laxmi Nagar, Near K.B.H Vidyalaya, Canada Corner, Nashik - 422005 Nashik MAHARASHTRA	9823021613 rush_manoj@yahoomail.com
Dr Rajneesh Kumar Calton	Christian Medical College and Hospital	Department of Cardiology, Brown Road, Ludhiana-141 008 Ludhiana PUNJAB	9878606736 caltonrajneesh@yahoo.in
Dr Deepak Namjoshi	Criti Care Multispeciality Hospital & Research Centre	Plot No. 39, Opp. Copper Chimney, Opp. Juhu Supreme Shopping Centre Main Gulmohar Road JVPD Scheme, Andheri (W), Mumbai-400049 Mumbai MAHARASHTRA	02226286644 dr.deepak6@rediffmail.com
Dr Ajay Dande	Dande Diabetes and Heart Care Centre	49 Bhagwant Maya Nagar N-2 Cidco, Near Hotel Deepali executive Aurangabad-431 003 Aurangabad MAHARASHTRA	02402488332 drdande@yahoo.com
Dr Naved Aslam	Dayanand Medical College and Hospital	Unit Hero DMC Heart Institute, Tagore Nagar Civil Lines, Ludhiana-141 001 Ludhiana PUNJAB	9876608744 drnavedaslam@yahoo.com
Dr Pothineni Ramesh Babu	Dr. Ramesh Cardilogy & Multispeciality hospital	Ramesh Cardiac & Multy Speciality Hospital; Citi Cardiac Research Center Ltd, Ring Road, Near ITI College, Vijayawada-520 008 Krishna ANDHRA PRADESH	08662484800 dr_rameshbabu_p@yahoo.co.in
Dr Atul Mathur	Escorts Heart Institute and Research Centre	B12 Senior Consultant Cardiology, Residents Tower [EHRIC], Okhala Road, New Delhi-110 025 New Delhi DELHI	01126825000 atul_mathur@hotmail.com
Dr Sanjeeb Roy	Fortis Escort hospital	Jawaharlal Nehru Marg Malviya Nagar, Jaipur, Rajasthan- 302017. Jaipur RAJASTHAN	0141-400-8151 sanjeeb.roy@fortishealthcare.com
Dr Bhima Shanker	Frontier Lifeline Hospital	R-30-C Ambattur Industrial Estate Road, Mogappair, Chennai - 600 101 Chennai TAMIL NADU	04442017575 anand_md@rediffmail.com
Dr Joy Thomas	Global Hospital	Global Hospital & Health city, 439- Cheran Nagar, Perumbakkam-600 101 Chennai TAMIL NADU	04422777100 joycardio@gmail.com
Dr Robin Pinto	Holy Family Hospital	St. Andrews Road, Bandra west, Mumbai-400 050 Mumbai MAHARASHTRA	9820076990 robinpinto@rediffmail.com
Dr Umesh Akalkotkar	Jehangir Hospital and Medical Centre	Jehangir Hospital and Medical Centre (J H M C), 32, Sassoon Road, Pune-411 001 Pune MAHARASHTRA	02026050550 noopuresh@yahoo.co.uk
Dr Milind Gadakari	K.E.M Hospital	489, Sardar Moodliar Road, Rastapeth, Pune - 411 011 Pune MAHARASHTRA	02066202260 gadkaris@gmail.com
Dr Padma Kumar	Kasturba Medical college	Dept of Cardiology, Madhav nagar, Manipal - 576104 Dakshina Kannada KARNATAKA	08202922838 padmakumar69@yahoo.com
Dr Milind Gadkari	KEM Hospital	489, Sardar Moodliar Road, Rastapeth, Pune - 411 011 Pune MAHARASHTRA	02066202260 gadkaris@gmail.com
Dr Thomas Alexender	Kovai Medical Centre	P. B. No. 3209, Avinashi Road Coimbatore-641 014 Coimbatore TAMIL NADU	04224323123 Tomalex41@gmail.com
Dr Sameer Dani	Lifecare Insitute of Medical Sciences and Research	Sardar Patel Statue Corner, Stadium Road, Naranpura Ahmedabad - 380 014 Ahmadabad GUJARAT	07940204020 drsameerdani@yahoo.com
Dr Jabir Abdullakutty	Lisie Hospital	Lisie Pullepady Road, P.B. # 3053, Kochi - 682018 Ernakulam KERALA	944701773 drjabi@yahoo.co.in
Dr Stigmon Joseph	Little Flower Hospital & Research Centre	P.B.no.23, Angamaly, Cochin - 683573 Ernakulam KERALA	04846062408 drstigij@yahoo.com
Dr Dinesh Dhanwal	Maulana Azad Medical College and Guru Nanak Eye Centre	B.L. Taneja Block, Maharaja Ranjit Singh Marg, New Delhi - 110 002 New Delhi DELHI	9968604275 dineshdhanwal@hotmail.com
Dr Rajashekar Reddy	Mediciti Hospital	Department of Cradiology, 5-9-22, Secretariat Road, Hyderabad-500 063 Hyderabad ANDHRA PRADESH	04023231111 raj28dr@yahoo.co.in
Dr Byrapaneni Ramesh Babu	Medwin Hospitals	Raghava Ratna Towers, Chirag Ali Lane, Hyderabad-500 001 Hyderabad ANDHRA PRADESH	04023204053 rameshbabubyrapaneni@yahoo.co.in
Dr Ravi Kumar	Meenakshi Mission Hospital and Research Centre	Lake Area, Melur Road Madurai-625020 Madurai TAMIL NADU	04524263113 ravekumar24@gmail.com
Dr Amancherla Ravikishore	Narayanan Hrudayalaya Institute of Medical Sciences	258/A, Bommasandra Industrial Area, Anekal Taluk, Hosur Road, Bangalore,-560 099 Bangalore KARNATAKA	0807835000 ravikishoreag@yahoo.co.in
Dr Mukund Kumble	Omega Hospital Pvt. Ltd.	Omega Hospital Pvt. Ltd., Mahaveera Circle, Kankanady, Mangalore-575 002 Dakshina Kannada KARNATAKA	08242430000 mukundkumble@hotmail.com
Dr Tiny Nair	P R S Hospital	Department of Cardiology, Killipalam Karamana, Trivandrum-695 002 Thiruvananthapuram KERALA	04712344443 tinynair@gmail.com
Dr Sunil Thanvi	P S Medical College and Shree Krishna Hospital	Bhanubhai and Madhuben Patel Cardiac Centre, Karamasad, Anand-388 325 Anand GUJARAT	02692222493 ssthanvi@yahoo.com
Dr Bhaskara Rao	Queens NRI Hospital	#50-53-14, Gurudwara Lane, Seethammadhara, Visakhapatnam, 530 013 Visakhapatnam ANDHRA PRADESH	09246624766 bhaskarstudies@hotmail.com
Dr Anil Jawahirani	Radiance Hospital	113-A Quetta Colony, Telephone Exchange Square, Nagpur - 440008 Nagpur MAHARASHTRA	07122765258 anilramesh123@rediffmail.com
Dr Jugal Bihari Gupta	S R Kalla Memorial Gastro and General Hospital	78 Dhuleshwar Garden Behind H S B C Bank, Sardar Patel Marg C Scheme, Jaipur-302001 Jaipur RAJASTHAN	9829414680 guptadrjb@rediffmail.com
Dr Nitin Ghaisas	Shatabdi Superspeciality Hospital	Suyojit City Centre Mumbai Naka Opposite Mahamarg Bus stand Nasik-422 005 Nashik MAHARASHTRA	02532593002 nghaisas@hotmail.com
Dr Aniruddha Dharmadhikari	Shree Saibaba Heart Institute and Research Centre	Near Kalidas Kala Mandir, Shalimar, Nashik-422002 Nashik MAHARASHTRA	9823033646 aniepaul@hotmail.com
Dr Nehal Sadhu	ShreeKrishna Hospital and Heart care centre	D-1 block, Shantiniketan Apt Opp. H B Kapadiya School, Gurukul Road Memnagar Ahmedabad-380 052 Ahmadabad GUJARAT	07927497979 drnehalsadhu@yahoo.com
Dr Niteen Deshpande	Spandan Heart Institute and research Centre	31 Off Chitaley Marg, Behind Hitavada Press, Dhantoli, Nagpur-440012 Nagpur MAHARASHTRA	9823056722 nvdesh@hotmail.com
Dr Naresh Kumar Goyal	Speciality Clinic	E-1083, Saraswati Vihar, Pitampura, New Delhi, 110034. New Delhi DELHI	09810331109 nkg71@yahoo.com
Dr Abhilash P Nair	Sree Gokulam Medical College & Research Foundation	Venjaramoodu, Thiruvananthapuram - 695607 Thiruvananthapuram KERALA	04723041234 cardiology_clinic@yahoo.com
Dr Ganpati Bantwal	St. Johns Medical College and Hospital	St. John’s Medical College & Hospital 34, Sarjapur road, Bangalore-560 034, Karnataka Bangalore KARNATAKA	08025530724 mallyaganapathi@rediffmail.com
Dr Shrenik Shah	Sterling Hospital	Sterling Hospital Road, Memnagar, Near Gurukul, Ahmedabad-380 052 Ahmadabad GUJARAT	07940011622 dr_shrenik@yahoo.co.in
Dr Nitish Garg	Tagore Heart Care and Research Centre	Banda Bahadur Nagar, Mahavir Marg, Jalandhar-144 008 Jalandhar PUNJAB	0112323400 drnitishgarg@gmail.com
Dr Arun Srinivas	Vikram Hospital and Heart Care	Vikram Hospital and Heart Care, 46 Vivekanand Road, Yadavagiri, Mysore-570 020 Mysore KARNATAKA	080212412121 cardiology@vhpl.com
Dr Padnihare Purayil Mohanan	West Fort Hi-tech Hospital	West Fort, Poonkunnam, Thrissur-680 002 Thrissur KERALA	04872388999 drppmohanan@gmail.com
Dr Guru Prakash	Yashoda group of Hospital	Somajiguda, Rajbhavan Road, Hyderabad-500 082 Hyderabad ANDHRA PRADESH	04023319999 heartsguru@gmail.com

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 54
Name of Committee	Approval Status
A J Institute of Medical Sciences - Ethics Committee	Approved
Apollo Gleneagles Hospital-Institutional Ethics Committee	Approved
Apollo Speciality Hospitals, Instituitional Ethics Committee	Approved
Bankers Ethics Committee, Vadodara	Approved
Baroda Heart Institute Ethics Committee	Approved
Canara Research Ethical Committee, Mangalore	Approved
Central India Medical Research Ethics Committee, Nagpur	Approved
Central India Medical Research Ethics Committee, Nagpur (For Radiance Hospital)	Approved
Christian Medical College Ethics Committee, Ludhiana	Approved
Citi Cardiac Institutional Ethics Committee, Vijayawada	Approved
Clinical Trial Ethics Committee-Bhatia Hospital, Mumbai	Approved
CLINICOM - Bangalore	Approved
CLINICOM Committee for Evaluation of Protocols for Clinical Research	Approved
Ethical / Research Committee, Bangalore	Approved
Ethical Committee, Nagpur	Approved
Ethical Control Committee, Aurangabad	Approved
Ethical Review Board, Meenakshi Mission Hospital & Research Center, Madurai	Approved
Ethics Committee of Life Care Institute of Medical Sciences and Research, Ahmedabad	Approved
Excel Society of Medical Sciences , Mumbai	Approved
Fortis Escort Hospital, Instituitional Ethics Committee Jaipur	Approved
Heart First Ethics Committee, Surat	Approved
Hirabai Cowasji Jehangir Medical Research Institute and Jehangir Clinical Development Centre Ethics Committee, Pune	Approved
Human Research Ethics Committee of H.M. Patel Centre for Medical Care and Research , Anand	Approved
Independent Ethics Committee, Mumbai	Approved
Independent Ethics Committee, New Delhi	Approved
Institute Ethics Committee, Queens NRI Hospital	Approved
Institutional Ethical Review Board, St. Johns Medical College & Hospital, Bangalore	Approved
Institutional Ethics Committee - Lisie Hospital	Approved
Institutional Ethics Committee Westfort Hi-tech Hospital, Thrissur	Approved
Institutional Ethics Committee, care Hospital, Hyderabad	Approved
Institutional Ethics Committee, Dayanand Medical College & Hospital, Ludhiana	Approved
Institutional Ethics Committee, Frontier Lifeline Pvt. Ltd, Chennai	Approved
Institutional Ethics Committee, Global Hospital and Health City, Chennai	Approved
Institutional Ethics Committee, Maulana Azad Medical College & Associated Lok Nayak, New Delhi	Approved
Institutional Ethics Committee, Medwin Hospital, Hyderabad	Approved
KEM Hospital Ethics Committee, Pune	Approved
KMCH Ethics Committee, Coimbatore	Approved
Little Flower Hospital and Research Centre	Approved
Magna Care Ethics Committee	Approved
Manavata Clinical Research Institute & Professional Ethics Committee, Nasik	Approved
Manipal University - Ethics Committee	Approved
PRS Hospital Ethics Committee, Trivandrum	Approved
S R Kalla Memorial Ethical Committee for Human Research, Jaipur	Approved
Shatabdi Superspeciality Hospital Ethics Committee, Nasik	Approved
SPECT - Ethical Review Board	Approved
Sree Gokulam Medical College Ethics Committee	Approved
Sterling Hospital Ethics Committee, Ahmedabad	Approved
Sujlam Independent Ethics Committee, Ahmedabad	Approved
Tagore Heart Care & Research Centre Pvt. Ltd Institutional Ethics Committee, Jalandhar	Approved
The Ethics Committee, Hyderabad	Approved
The Institution Ethics Committee, Deenanath Mangeshkar Hospital & research Center, Pune	Approved
Vikram Hospital Ethics Committee, Mysore	Approved
Vivus Live and Shine Instituitional Review Board	Approved
Yashoda Academy of Medical Education & Research, Secunderabad	Approved

Regulatory Clearance Status from DCGI
Modification(s)

Status

Approved/Obtained

Health Condition / Problems Studied
Modification(s)

Health Type	Condition
Patients	Cardiovascular Outcomes in Subjects with Type 2 Diabetes and Acute Coronary Syndrome,

Intervention / Comparator Agent
Modification(s)

Type	Name	Details
Intervention	Alogliptin	Alogliptin 25 mg, tablets, orally, once daily for up to 4.75 years for patients with normal or mildly impaired renal function as defined by estimated glomerular filtration rate. Alogliptin 12.5 mg, tablets, orally, once daily for up to 4.75 years for patients with moderately impaired renal function as defined by estimated glomerular filtration rate. Alogliptin 6.25 mg, tablets, orally, once daily for up to 4.75 years for patients with severely impaired renal function or end stage renal disease defined by estimated glomerular filtration rate.
Comparator Agent	NIL	NIL
Intervention	Placebo	Alogliptin placebo matching tablets, orally, once daily for up to 4.75 years.

Inclusion Criteria
Modification(s)

Age From	18.00 Year(s)
Age To	80.00 Year(s)
Gender	Both
Details	-Diagnosis of type 2 diabetes mellitus -Subject is receiving monotherapy or combination antidiabetic therapy with a glycosylated hemoglobin level between 6.5% and 11.0%, inclusive, at Screening (between 7.0 and 9.0%, inclusive, if the subjects antidiabetic regimen includes insulin) -Diagnosis of acute coronary syndrome within 15 to 90 days prior to randomization

ExclusionCriteria

Details

-Signs of type 1 diabetes mellitus -Currently receiving a glucagon-like peptide-1 analogue for glycemic control of type 2 diabetes mellitus at Screening -Received a dipeptidyl peptidase-4 inhibitor for either more than 14 days total or within the 3 months prior to Screening

Method of Generating Random Sequence
Modification(s)

Stratified randomization

Method of Concealment
Modification(s)

Centralized

Blinding/Masking
Modification(s)

Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

Primary Outcome
Modification(s)

Outcome	TimePoints
Time from randomization to the occurrence of the Primary Major Adverse Cardiac Events, defined as a composite of cardiovascular death, nonfatal myocardial infarction and nonfatal stroke.	4.75 years

Secondary Outcome
Modification(s)

Outcome	TimePoints
Time from randomization to the occurrence of the Secondary Major Adverse Cardiac Events defined as a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke and urgent revascularization due to unstable angina.	4.75 years

Target Sample Size
Modification(s)

Total Sample Size="5400"
Sample Size from India="400"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)=""

Phase of Trial
Modification(s)

Phase 3

Date of First Enrollment (India)
Modification(s)

04/03/2010

Date of Study Completion (India)

Date Missing

Date of First Enrollment (Global)

16/10/2009

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial
Modification(s)

Years="4"
Months="9"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Completed

Recruitment Status of Trial (India)

Completed

Publication Details
Modification(s)

NIL

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Brief Summary
Modification(s)

Introduction: Alogliptin is a selective and potent dipeptidyl peptidase-4 inhibitor currently being developed by Takeda for use in patients with type 2 diabetes mellitus. Results from five phase 3 double-blind, placebo-controlled, 26-week studies have demonstrated that alogliptin is effective in reducing glycosylated hemoglobin as monotherapy and when added to commonly used antidiabetic agents, including sulfonylureas, metformin, thiazolidinediones, and insulin. Alogliptin is well-tolerated and associated with few adverse events. Cardiovascular outcomes is of special interest in the type 2 diabetes mellitus population, particularly in type 2 diabetes mellitus subjects who have cardiovascular disease and are at high risk for major adverse cardiac events, such as those patients who have had recent acute coronary syndrome.

Study Design: This study has been designed to evaluate the cardiovascular safety of alogliptin versus placebo in addition to Standard of Care in subjects with type 2 diabetes mellitus and acute coronary syndrome.