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CTRI Number  CTRI/2017/04/008410 [Registered on: 25/04/2017] Trial Registered Prospectively
Last Modified On: 19/04/2017
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   Clinical study of Alogliptin in Patients With Type 2 Diabetes Mellitus 
Scientific Title of Study   A Prospective, Multi-center, Open-label, Phase IV Study to Evaluate the Safety and Efficacy of Alogliptin as Monotherapy or Add on Therapy in Indian Patients With Type 2 Diabetes Mellitus 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
SYR-322-4001 amendment 1 dated 21 July 2016  Protocol Number 
U1111-1174-1852  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query
 
Name  Dr Prashant Agrawal 
Designation  Manager Medical Affairs 
Affiliation  Takeda Pharmaceuticals India Pvt. Ltd. 
Address  Takeda Pharmaceuticals India Pvt. Ltd The Capital, A wing, 15th Floor, 1504, Plot No C-70, G-Block, Bandra Kurla Complex Bandra East,Mumbai

Mumbai
MAHARASHTRA
400 051
India 
Phone  02261249925  
Fax  02261249988  
Email  Prashant.agrawal@takeda.com  
 
Details of Contact Person
Public Query
 
Name  Dr Prashant Agrawal 
Designation  Manager Medical Affairs 
Affiliation  Takeda Pharmaceuticals India Pvt. Ltd. 
Address  Takeda Pharmaceuticals India Pvt. Ltd The Capital, A wing, 15th Floor, 1504, Plot No C-70, G-Block, Bandra Kurla Complex Bandra East,Mumbai

Mumbai
MAHARASHTRA
400 051
India 
Phone  02261249925  
Fax  02261249988  
Email  Prashant.agrawal@takeda.com  
 
Source of Monetary or Material Support  
Takeda Pharmaceuticals India Pvt. Ltd. The Capital, A wing, 15th Floor, 1504, G-Block, Bandra Kurla Complex Bandra East,Mumbai 400 051 
 
Primary Sponsor  
Name  Takeda Pharmaceuticals India Pvt Ltd 
Address  The Capital, Awing, 15th Floor, 1504, Plot No C-70, G-Block, Bandra Kurla Complex Bandra East,Mumbai 400051 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
SIRO Clinpharm Pvt Ltd   1st floor, Unit Nos. 3 & 4, Plot no. D-3, Road No. 16, Wagle Industrial Estate, Thane West, Thane, Maharashtra 400604 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 18  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sanjay Chatterjee  Apollo Gleneagles  58, Canal Circular road, Kolkata, West Bengal 700054, India
Kolkata
WEST BENGAL 
9831032310

sanjay_doc@yahoo.co.in 
Dr Adlyne Reena Solomon  Arthur Asirvatham Hospital  42-A, Kuruvikaran Salai, Near Anna Bus Stand, Madurai- 625 020
Madurai
TAMIL NADU 
9843051977

adlynereenaasirvatham@yahoo.com 
Dr SV Deshpande  Ashirwad Hospital & Research Centre  Maratha Section, Near Jijamata Udyan, Station Road, Ulhasnagar, Mumbai- 421 004
Mumbai
MAHARASHTRA 
9822017445

writetoshrikant@rediffmail.com 
Dr Bhupendra Narayan Mahanta  Assam Medical College and hospital  Medicaine dept, Barbari, Dibrugarh, Assam 786002
Dibrugarh
ASSAM 
9435030599

drbnmahanta@hotmail.com 
Dr Promod Umarji  BJGMC & Sasosoon General Hospital  Jai Prakash Narayna Road, Near Pune Station, Pune 411001
Pune
MAHARASHTRA 
9822307068

mpumarji@gmail.com 
Dr SK Sharma  Diabetes, Thyroid and Endocrine Center  A-1, Madrampura, Ajmer Road, Near 4no. ESI Hospital Jaipur-302006 (Rajasthan)
Jaipur
RAJASTHAN 
9829010233

sksharmacr@gmail.com 
Dr Shembalkar  Getwell Hospital and Research  Institute, 20/1 Khare Marg, Dhantoli, Nagpur-440012
Nagpur
MAHARASHTRA 
9665013901

drshembalkar@gmail.com 
Dr Ashutosh Somalwar  Government Medical college and hospital  Medical college square, Nagpur, Maharashtra 440003,India
Nagpur
MAHARASHTRA 
9850301640

amsomalwar@gmail.com 
Dr Rajshree Khot  Indira Gandhi Government Medical College and Hospital  Central Avenue Road, Opp Railway Station, Nagpur, Maharashtra 440008
Nagpur
MAHARASHTRA 
9823134598

rajashree.s.khot@gmail.com 
Dr KAV Subrahmanyam  King George Hospital.  Maharanipeta, Visakhapatnam- 530 002
Visakhapatnam
ANDHRA PRADESH 
9848149536

kavsendo@yahoo.co.in 
Dr Balamurugan  Kovai Diabetes Speciality Centre and Hospital  15, Vivekananda Road, Ram Nagar, Coimbatore- 641 009
Coimbatore
TAMIL NADU 
9842244881

rbmkdsc@gmail.com 
Dr Jaiganesh Muruganandam  M V Hospital for Diabetes Pvt. Ltd  No. 5, West Mada Church Street, Royapuram, Chennai- 600 013
Chennai
TAMIL NADU 
9094053261

jaiganeshat@yahoo.co.in 
Dr Brahme Keyur Madan  Medical College Baroda & Sir Sayajirao General (SSG)  Hospital, Anandpura, Baroda 390001, Gujarat
Vadodara
GUJARAT 
9727729105

keyurbrahme@gmail.com 
Dr Rakesh Sahay  Osmania General Hospital  Golden Jubilee Block, Afzalgunj, Hyderabad- 500 012
Hyderabad
ANDHRA PRADESH 
9849597507

rakeshsahay@rediffmail.com 
Dr Shushil Kumar Gupta  Sanjay Gandhi Post Graduate Institute of Medical Sciences  Department of Endocrinology, Raebareli Road, Lucknow, UP-226014
Lucknow
UTTAR PRADESH 
9415200400

sushilguptasgpgi@gmail.com 
Dr Ajay Bulle  Shree Hospital & Critical Care Centre  799, Om Nagar, Opposite Tajshree Building, Sakkardara square, Nagpur-440009, Maharashtra
Nagpur
MAHARASHTRA 
9320126340

drajaybulle@gmail.com 
Dr Puneet Saxena  SMS Medical College and attached hospitals G-1 Department of Medicine, Dhanvantri   G-1 Department of Medicine, Dhanvantri OPD Block, Jaipur 302004
Jaipur
RAJASTHAN 
9414079182

puneetsaxena96@yahoo.co.in 
Dr Pravin Supe  Supe Heart & Diabetes Hospital & Research Centre  Opposite Adharashram, Gharpure Ghat, Near Rungtha High School, Ashok Stambh, Nashik- 422 002
Nashik
MAHARASHTRA 
9405366165

pravinsupe@ymail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 18  
Name of Committee  Approval Status 
Apollo Gleneagles  Submittted/Under Review 
Ashirwad Ethics Committee  Approved 
Assam Medical College and hospital  Submittted/Under Review 
Ethics Committee, Osmania Medical College & Osmania General Hospital  Approved 
Getwell Institutional Ethics Committee, Getwell Hospital and Research Institute  Approved 
Getwell Institutional Ethics Committee, Getwell Hospital and Research Institute  Approved 
Indira Gandhi Government Medical College and Hospital  Submittted/Under Review 
Institutional Ethics Committee Human Welfare Ethical Committee for human sciences and research  Approved 
Institutional Ethics Committee for Human Research, Medical College Baroda  Submittted/Under Review 
Institutional Ethics Committee of Kovai Diabetes Speciality Centre and Hospital  Approved 
INSTITUTIONAL ETHICS COMMITTEE PROF. M. VISWANATHAN DIABETES RESEARCH CENTRE  Approved 
Institutional Ethics Committee, Arthur Asirvatham Hospital  Approved 
Institutional Ethics Committee, Department of Pharmacology, BJ Government Medical College & Sassoon General Hospital  Submittted/Under Review 
Institutional Ethics Committee, dept of Pharmacology, Government Medical college and hospital  Approved 
Institutional Ethics Committee, King George Hospital, Maharanipeta  Approved 
Shree Hospital Ethics Committee  Approved 
SMS Medical College and attached hospitals  Submittted/Under Review 
Supe Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Type 2 Diabetes Mellitus ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Alogliptin tablets 25 mg/12.5 mg/6.5 mg   Alogliptin tablets 25 mg/12.5 mg/6.5 mg, tablets, orally, once, daily for 26 weeks in addition to standard care for the management of Type 2 Diabetes Mellitus (T2DM). 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. In the opinion of the Investigator, the subject is capable of understanding and complying with protocol requirements.
2. Male and female patients, ≥18 years, who in Investigator’s opinion are eligible to receive
alogliptin as per locally approved prescribing information along with standard care for
management of T2DM;
3. Patients with T2DM who are DPP-4 inhibitor- naïve; including alogliptin.
4. Patients willing to give written informed consent to participate in the study and also
willing to give consent for audio-video recording of the entire informed consent process.
5. A female subject of childbearing potential who is sexually active with a nonsterilized
male partner agrees to use routinely adequate contraception from signing of informed
consent throughout the duration of the study.
 
 
ExclusionCriteria 
Details  1. Contraindication or limitation for administration of alogliptin tablets according to the approved label/Prescribing Information;
2. Patients treated with alogliptin tablets outside the approved label/ prescribing information.
3. The subject with end-stage renal disease (ESRD) (Creatinine Clearance (CrCl) <15
mL/min or requiring hemodialysis).
4. The subject has received any investigational compound within 30 days prior to the first
dose of study medication.
5. The subject is an immediate family member or is in a dependant relationship with a study
site employee who is involved in conduct of this study (e.g., spouse, parent, child, sibling) or may consent under duress.
6. If female, the subject is pregnant or lactating or intending to become pregnant before, during, or within 30 days after last dose of study medication; or intending to donate ova during such time period. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

Percentage of Participants with Adverse Drug Reactions (ADRs) and Unexpected ADRs
Change from Baseline in Glycosylated Haemoglobin (HbA1c)
Percentage of Participants with Glycosylated Hemoglobin 7.0% 
week 0
week 13
week 26
week 30 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   31/05/2017 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="15" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None Yet  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

This is a A Prospective, Multi-center, Open-label, Phase IV Study to Evaluate the Safety and Efficacy of Alogliptin as Monotherapy or Add on Therapy in Indian Patients With Type 2 Diabetes Mellitus 

The drug being tested in this study is called alogliptin. Alogliptin is being tested to treat people who have Type 2 Diabetes Mellitus (T2DM). This study will look at side effects and glycemic control in people who take alogliptin in addition to standard care.

The study will enroll approximately 300 patients. All participants will receive alogliptin tablets at a dose determined based on the creatinine clearance. The recommended dose of alogliptin is 25 mg once daily with normal or mildly impaired renal function (creatinine clearance [CrCl] ≥60 mL/min), dose of 12.5 mg for participants with moderate renal impairment (CrCl ≥30 to <60 mL/min),

and 6.25 mg for participants severe renal impairment (CrCl ≥15 to <30 mL/ min). Participants with end-stage renal disease (ESRD) (CrCl <15 mL/min or requiring hemodialysis) will be excluded, in addition to standard care for the management of T2DM.

All participants will be asked to take one tablet every morning each day throughout the study.


This multi-center trial will be conducted in India. The overall time to participate in this study is up to 33 weeks. Participants will make multiple visits to the clinic, and will be contacted by telephone 30 days after last dose of study drug for a follow-up assessment.  
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