CTRI/2014/08/004827 [Registered on: 05/08/2014] Trial Registered Prospectively
Last Modified On:
06/07/2016
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
A clinical trial to study the effect of Fixed Dose Combination of Teneligliptin and Metformin Tablet in the treatment of patients with Type 2 Diabetes Mellitus.
Scientific Title of Study
A Randomized, Double Blind, Double Dummy, Comparative, Prospective, Multicenter, Parallel Study to assess Efficacy, Safety and Tolerability of Fixed Dose Combination of Teneligliptin and Metformin Tablet Compared with Metformin monotherapy in Adult Patients with Type 2 Diabetes Mellitus Inadequately Controlled on Metformin Alone.
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
GPL/CT/2013/003/III; version 2.0, dated:21.02.2014
Protocol Number
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 Piyush Agarwal
Designation
Deputy General Manager
Affiliation
Glenmark Pharmaceuticals Ltd
Address
Glenmark Pharmaceuticals Ltd Glenmark House, B D Sawant Marg Chakala, Andheri(East) Mumbai
Basement Floor, Opp. Administration Dept.
Survey No. 15, Fatima Nagar, Pune – 411040
Pune MAHARASHTRA
91-20-66812435
pykadam10@gmail.com
Dr Danda Srinivas
Indus Hospitals
Department of Internal Medicine, Ground floor, KGH Down Road, Maharanipeta, Visakhapatnam – 530002 Visakhapatnam ANDHRA PRADESH
91-891-2508881
drdsrinivas1978@gmail.com
Dr C S Yajnik
KEM Hospital Research Centre
Diabetes Unit, Research Centre Unit, 6th Floor, Banoo Coyaji Building, Sardar Moodliar Road, Rasta Peth, Pune – 411011
Pune MAHARASHTRA
91-20-66405731
csyajnik@hotmail.com
Dr B Vivekanand
King George Hospital
Department of Endocrinology, Super Speciality Block, 1st
Floor, King George Hospital, Maharanipeta, Visakhapatnam –530002
Visakhapatnam ANDHRA PRADESH
08912508275
drvivek_78@yahoo.com
Dr D Himanshu
King George’s Medical University
Department of Endocrinology,
Doctors chambers, 2nd Floor,
King George’s Medical University, Chowk, Lucknow – 226003
Lucknow UTTAR PRADESH
91-9839266822
dr.himanshureddy@gmail.com
Dr R Balamurugan
Kovai Diabetes Speciality Centre & Hospital
15, Vivekanand Road, Ramnagar, Coimbatore -641009 Coimbatore TAMIL NADU
9842244881
balamurugan_dr@hotmail.com
Dr Vinod Kumar Pavithran
KVM Multi Specialty Hospital
Department of General Medicine, Ground floor, KVM Hospital, PB No. -30, Cherthala, Kerala – 688524
Alappuzha KERALA
91-9446378522
drvinodkvm@gmail.com
Dr Nivedita Moulick
LokmanyaTilak Municipal General Hospital and LTM General Hospials
Department of Medicine, Building No.3,College Building 1st Floor, Endocrine Division, LTMMC & LTMGH, Sion, Mumbai - 400022 Mumbai MAHARASHTRA
91-22-24063076
ndmoulick@rediffmail.com
Dr Hemanga Barman
M.V. Hospital for Diabetes Pvt. Ltd.
No. 4, West Mada Chruch Street, Royapuram, Chennai - 600013 Chennai TAMIL NADU
044-25954913
drbarmanh007@rediffmail.com
Dr Laxmikant Goyal
Malpani Multispecialty Hospital
Basement Floor, Department of Clinical Research, S P -6, Road No. 1, VKI Area, Sikar Road, Jaipur -302013 Jaipur RAJASTHAN
91-141-2333886
drlkgoyal@gmail.com
Dr Rajesh Nair
Mar Augustine Golden Jubilee Hospital
Department of General Medicine, Ground floor, P. O. Mookkannoor, Angamali, Ernakulam (District), Kerala- 683577 Ernakulam KERALA
91-484-2616869
drnairrajesh@gmail.com
Dr Sandeep Jain
Marudhar Hospital
A 93-99, Singh bhoomi, Khatipura, Jaipur - 302012 Jaipur RAJASTHAN
9414069583
drsandeeprjain@yahoo.co.in
Dr Mahendra Parmar
Medical College, Baroda and SSG Hospital
Department of Medicine, Ground Floor, Baroda Medical College(SSG Hospital) Sayajiganj, Vadodara -390001 Vadodara GUJARAT
91-265-2424848
mcparmar1961@gmail.com
Dr Bhatia Shailaja Girish
Medipoint Hospitals Pvt. Ltd.
Ground Floor,241/1, New D. P. Road, Aundh, Pune – 411007 Pune MAHARASHTRA
153, Magarpatta City Road, Pune - 411013 Pune MAHARASHTRA
020-66285000
drshri2000@yahoo.com
Dr Samir Dasgupta
Peerless Hospitex Hospital & Research Center Limited
Department of Diabetology & Endocrinology ,1st Floor,360 Panchasayar ,Kolkata - 700 094 Kolkata WEST BENGAL
91-9830190232
sugarwars@gmail.com
Dr Nirav Bhalani
Rhythm Heart Institute
5-9, Lakulesh Park Society, Near Sadhuvasvani School, New VIP Road, Vadodara - 390022, Gujarat Vadodara GUJARAT
0265-2486111
drniravbhalani@hotmail.com
Dr B L N Prasad
RIMS Government General Hospital
Dept. of Medicine, OPD Room No- 13, 1 Floor, Rajiv Gandhi Institute of Medical Sciences and RIMS Government General Hospital, Srikakulam - 532001 Srikakulam ANDHRA PRADESH
91-8942279033
amcmedicine@hotmail.com
Dr Avinash Kulkarni
Sahyadri Speciality Hospital
30C, Erandwane, Karve Road, Pune - 411004 Pune MAHARASHTRA
020-25403000
adkul1957@gmail.com
Dr Subhash B Yadav
Sanjay Gandhi Post Graduate Institute & Medical Sciences
Department of Endocrinology,
Room No 10, Ground Floor, Raibareli Road, Lucknow– 226014
Lucknow UTTAR PRADESH
0522-2668017
subhash70@gmail.com
Dr Vivek Arya
Sanjivni Super specilty Hospital Privated Limited
1, Uday Park Society, Nr Sunrise Park, Vastrapur, Ahmedabad-380015 Ahmadabad GUJARAT
9879537973
Vivekarya007@yahoo.com
Dr Sadanand C D
Sapthagiri Institute of Medical Sciences and Research Centre
# 15, Chikkasandra, Hesaragatta Main Road, Banglore-560090 Bangalore KARNATAKA
9986143260
suri@rediffmail.com
Dr Kunal Jhaveri
Saviour Multispecilty Hospital
Near Bharat Petrol Pump, Near Lakhudi Talav, Stadium Road, Navrangpura, Ahmedabad-380014 Ahmadabad GUJARAT
9824093938
kunal.vcim@gmail.com
Dr Prakash Kurmi
Shivam Medical Hospital
C-4, Satyanarayan Society, Gor no Kuvo, Jasodanagar Char Rasta, Maninagar, Ahmedabad - 380008, Gujarat Ahmadabad GUJARAT
079-25855830
dr_prakashkurmi@yahoo.co.in
Dr Mayank Thakkar
Shree Giriraj Multispeciality Hospital
150 feet Ring Road, 27 - Navjyot Park, Main Road, Amin Marg Cross Road, Rajkot - 360005, Gujarat Rajkot GUJARAT
91-9714991559
drmayankthakkar@shrigirirajhospital.com
Dr Govind Kulkarni
Shree Hospital
Siddharth Mansion, Nagar Road, Opposite Aga Khan Palace, Pune - 411006 Pune MAHARASHTRA
020-26681127
drgdk2001@yahoo.co.uk
Dr Surender Kumar
Sir Ganga Ram Hospital
Department of Endocrinology & Metabolism, F 47, First Floor, Old Building, Sir Ganga Ram Hospital , Sir Ganga Ram Hospital Marg, Rajinder Nagar, New Delhi – 110060 New Delhi DELHI
91-11-42251636
doctorsuren@yahoo.co.uk
Dr Prakash Keswani
SMS Hospital
2nd Floor, Medical Unit, Department of Medicine, JLNMarg, Jaipur -302004 Jaipur RAJASTHAN
919829145524
drkeshwanisms@gmail.com
Dr Jitender Lakhani
Smt. B. K. Shah Medical Institute & research Centre & Dhiraj Hospital
Type 2 Diabetes Mellitus Inadequately Controlled on Metformin Alone.,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Fixed Dose Combination of Teneligliptin 20 mg and Metformin 1000 mg Tablets
administered 1 or 2 tablet/s once daily for 24 weeks
Comparator Agent
Metformin 1000 mg Tablets
administered 1 or 2 tablet/s once daily for 24 weeks
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1. Patients age ≥18 and ≤65 years inclusive of either sex willing to give their written informed consent and comply with the protocol requirements.
2. Patients with Type 2 Diabetes Mellitus who have been treated with upto 1 gram per day of Metformin monotherapy for at least 3 months prior to screening and having inadequate glycaemic control [Glycosylated Haemoglobin (HbA1c) levels of >7% to ≤ 9%].
ExclusionCriteria
Details
1. Pregnant or lactating women.
2. Female Patient of child bearing potential who do not agree to remain abstinent or use medically acceptable methods of contraception during the study therapy and for 4 weeks after the end of study therapy.
3. Patient with Type 1 diabetes mellitus or secondary form of diabetes.
4. Patients with known hypersensitivity to any of the components of the formulation.
5. Known cases of diabetic nephropathy, diabetic ketoacidosis, diabetic coma, hyperglycemia hyperosmolar state, retinopathy, neuropathy or other diabetic complications of sufficient severity to require treatment like severe Peripheral Neuropathy, Symptomatic Orthostatic Hypotension, Urinary Retention, Foot ulcers, or Gastric Stasis.
6. Patients who have a recent history or who are currently known to abuse alcohol or drugs.
7. Patients with clinically significant renal, hepatic, or cerebrovascular disease, known pituitary or gastric dysfunction, malignancy, thyroid dysfunction, chronic uncontrolled systemic diseases like asthma, collagen disorders, severe infection etc. or any other medical illness that may affect patient safety or difficult to evaluate the efficacy of the product.
8. Patients receiving treatment with systemic corticosteroids.
9. Patients who have participated in any clinical trial in the past 1 month.
10. Any other condition that in the opinion of the Investigator that does not justify the patient’s participation in the study.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Pre-numbered or coded identical Containers
Blinding/Masking
Double Blind Double Dummy
Primary Outcome
Outcome
TimePoints
Mean Change in Glycosylated Haemoglobin (HbA1c) levels
24 weeks
Secondary Outcome
Outcome
TimePoints
Proportion of patients achieving the goal of HbA1c ≤7% level
24 weeks
Mean Change in Fasting and Postprandial Plasma Glucose (FPG and PPG)
24 weeks
Target Sample Size
Total Sample Size="378" Sample Size from India="378" Final Enrollment numbers achieved (Total)= "" Final Enrollment numbers achieved (India)=""
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
This is double-blind, double dummy, randomized, active controlled, two-arm, parallel-group, comparative study. Study will enroll 378 subjects with type 2 diabetes from the different centres in India.
Patients will be recruited after providing written informed consent. After screening, patients will be randomized (meeting randomization criteria) in 1:1 ratio to receive either Fixed Dose Combination of Teneligliptin and Metformin or Metformin for 24 weeks. The primary objective of the study is to see the mean change in Glycosylated Haemoglobin (HbA1c) levels at the end of treatment. Secondary objective includes proportion of patients achieving the goal of ≤7.0% HbA1c level, mean change for fasting and postprandial plasma glucose. During the study, there will be 7 study visits for efficacy, safety and tolerability assessment.