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
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.