Safety and Efficacy of Exenatide Injection in Subjects with Type 2 Diabetes Mellitus: 24 Week Trial
Scientific Title of Study
Safety and Efficacy of Exenatide Injection in Subjects with Type 2 Diabetes Mellitus: A Randomized, Double Blind, Placebo-Controlled, Parallel Group, Multicentric, 24 Week Trial.
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)
Name
Dr Mudgal Kothekar MD
Designation
Associate Vice President - Clinical Development
Affiliation
Sun Pharma Advanced Research Company Ltd
Address
Sun Pharma Advanced Research Company Ltd,
17-B Mahal Industrial Estate,
Mahakali Caves Road, Andheri (E),
Mumbai – 400 093
India
Sun Pharma Advanced Research Company Ltd,
17-B Mahal Industrial Estate,
Mahakali Caves Road, Andheri (E),
Mumbai – 400 093
India
Mumbai MAHARASHTRA 400 093 India
Sun Pharma Advanced Research Company Ltd,
17-B Mahal Industrial Estate,
Mahakali Caves Road, Andheri (E),
Mumbai – 400 093
India
Sun Pharma Advanced Research Company Ltd,
17-B Mahal Industrial Estate,
Mahakali Caves Road, Andheri (E),
Mumbai – 400 093
India
Mumbai MAHARASHTRA 400 093 India
Sun Pharma Advanced Research Company Ltd,
17-B Mahal Industrial Estate,
Mahakali Caves Road, Andheri (E),
Mumbai – 400 093
India
Sun Pharma Advanced Research Company Ltd,
17-B Mahal Industrial Estate,
Mahakali Caves Road, Andheri (E),
Mumbai – 400 093
India
Mumbai MAHARASHTRA 400 093 India
BGS Global Hospitals, BGS Health & Education City, Endocrinology Department, #67, Uttarahalli Road,Kengeri-560060.Bangalore, Karnataka
Bangalore KARNATAKA
9731533636
babu09_uk@yahoo.co.uk
Dr Dukhabandhu Naik
Christian medical college hospital
Christian Medical College, Department of endocrinology,
Vellore - 632004 Vellore TAMIL NADU
9700146888
drnaik2000@gmail.com
Dr Surendra K Sharma
Diabetes, Thyroid and Endocrine Centre,
A-1, Madarampura, near 4 no. ESI Hospital, Ajmer Road, Jaipur 302006, Rajasthan. Jaipur RAJASTHAN
9829010233
sksharma7@gmail.com
Dr Jay Karnani
Dr. Jay Karnanis clinic,
4, stadium house, Ground floor, opp. municipal swimming pool, Navrangpura, Ahmedabad- 380009 Ahmadabad GUJARAT
9824039232
Jkarnani@indiatimes.com
DrR Srinivasan
G. Kuppuswamy Naidu Memorial Hospital
G. Kuppuswamy Naidu Memorial Hospital, P.B. No. 6327, Nethaji Road, Pappanaickenpalayam, Coimbatore. Tamil Nadu-641037, India
Coimbatore TAMIL NADU
9600933080
srinir02@gmail.com
DrJayeshree Shembhalkar
Getwell Hospital and Research Institute
Getwell Hospital and Research Institute, Lokmat Square, Dhantoli, Nagpur-440012.Maharashtra, India
Nagpur MAHARASHTRA
9665013901
pkshembalkar@hotmail.com
Dr Mohan Magdum
Ira Clinic
Shirole Road,
1205/1-2 Shivaji Nagar,
Pune - 411004. Pune MAHARASHTRA
9822217243
mohanmagdum@gmail.com
Dr Alok Kanungo
Kanungo Institute of Diabetes Specialities Pvt. Ltd.
Kanungo Institute of Diabetes Specialities Pvt. Ltd., Plot No – 1120, Dumduma, Bhubaneswar – 751019, Orissa
Cuttack ORISSA
9437055740
kanungokids@gmail.com
DrSudha Vidyasagar
Kasturba Hospital
Kasturba medical college and hospital, Clinical research, Near KMC Dean office, Mezzamina floor, KMC old library building, Manipal - 576104, Karnataka Udupi KARNATAKA
9880083580
vsagar33@yahoo.com
Dr K A V Subrahmanium
King George Hospital
King George Hospital, Down road, Maharani Peta, Vishakhapatnam-530002.
Visakhapatnam ANDHRA PRADESH
9848149536
kavsendo@yahoo.co.in
DrD Himanshu
King Georges Medical College,
Shah Mina Road, Chowk, Lucknow-226003.Uttar Pradesh, India
Lucknow UTTAR PRADESH
9769397917
dr.himanshu.reddy@gmail.com
DrBalamurugan
Kovai Diabetes Speciality Center and Hospital
Kovai Diabetes Speciality Center and Hospital,15, Vivekananda Road , Ramnagar, Coimbatore-641009.Tamil Nadu, India
Coimbatore TAMIL NADU
9842244881
balamurugan_dr@hotmail.com
Dr Bipin Shah
Krishnashray hospital,
Sanstha vasahat, Raopura, near Ushakiran building, Baroda-390001 Vadodara GUJARAT
2, 1st Floor, K. B. Commercial Centre, Khanpur, Ahmedabad-380001. Ahmadabad GUJARAT
9879160345
vkabichandani@yahoo.co.in
Dr Pawan Gangwal
S. R. Kalla Memorial Gastro & General Hospital,
S. R. Kalla Memorial Gastro & General Hospital, 78, Dhuleshwar Garden, Behind HSBC Bank , Sardar Patel Marg, C - Scheme, Jaipur- 302001.
Jaipur RAJASTHAN
9782640746
drpgangwal2014@gmail.com
Dr Dhiren Patel
Sanjivani Hospital and ICCU Centre,
Opp. Vidhyabharti School, Bhatar Road, Surat-395001. Surat GUJARAT
401-402, Jay complex, Hirabag Circle, Varachha main road, Surat 395006. Surat GUJARAT
9825312027
shreejihospitalsurat@gmail.com
Dr Krishnan Seshadri
Shri Ramachandra Medical College & Research Institute
Shri Ramachandra Medical College & Research Institute,A1 Private Clinic, Dept of Endocrinology, Diabetes & Metabolism, Porur, Chennai-600116.India
Chennai TAMIL NADU
9940068170
krishnagseshadri@gmail.com
Dr Jashvant Shah
Sonal Hospital and Diabetes Clinic,
12/925 Firoz Chambers, 3rd floor, lal gate, Khand Bazar, Surat 395003. Surat GUJARAT
9825138477
drjlshah@yahoo.com
Dr Ganpathi Bantwal
St John Medical College and Hospital
St. Johns Medical College and Hospital, Department of Endocrinology, Sarjapur Road, Bangalore - 560034.
Bangalore KARNATAKA
080-22065649
mallyaganapathi@rediffmail.com
Dr Sunil Gupta
Sunils Diabetes Care and Research Centre Pvt. Ltd.
Sunils diabetes care and research center Pvt. Ltd.42, Lendra Park,Ramdas Peth,Nagpur-440010
Nagpur MAHARASHTRA
9823152111
drsgupta_ngp@rediffmail.com
Dr Sunil Jain
TOTALL Diabetes Hormone Institute,
TOTALL Diabetes Hormone Institute, BCM Health Island,PU-4 Scheme no 54, Near Bombay Hospital, Behind Prestige management Institute,Indore-452010.
Indore MADHYA PRADESH
Type 2 diabetes mellitus , (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Exenatide injection:
5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the next 20 weeks. To be self-administered twice daily in the thigh, abdomen, or upper arm within the 60-minute period before the morning and evening meals (or before the two main meals of the day, approximately 6 hours or more apart).
Comparator Agent
Placebo
5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the next 20 weeks. To be self-administered twice daily in the thigh, abdomen, or upper arm within the 60-minute period before the morning and evening meals (or before the two main meals of the day, approximately 6 hours or more apart).
Inclusion Criteria
Age From
20.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
1.Male and female subjects 20 years of age and older.
2.Established clinical diagnosis of type 2 diabetes mellitus treated with diet and exercise or anti-diabetic agents as monotherapy or combination therapy.
3.Weight stable
4.Women of child-bearing potential must be practicing an acceptable method of birth control as judged by the investigator
5.Willing to participate and give written informed consent.
ExclusionCriteria
Details
1.Previous exposure to exenatide
2.Current or previous exposure to insulin.
3.Used drugs for weight loss
4.Currently treated with any of the excluded medications
5.Received treatment within the last 3 months with a drug that has not received regulatory approval for indication at the time of trial entry
6.Type 1 diabetes mellitus.
7.Severe renal impairment
8.A history of renal transplantation or currently on renal dialysis.
9.History of pancreatitis.
10.A known allergy to any components contained in the exenatide injection.
11.A history of severe gastrointestinal disease
12.Pregnant or lactating females
13.History of chronic pancreatitis
14.Immunosuppressed or requiring treatment with an immunosuppressant or recently received an immunosuppressant, including systemic corticosteroids.
15.History of immune deficiency syndrome or HIV positive
This is a randomized, double blind,
placebo-controlled, parallel groups, multicentric, 24-week trial to assess the Safety and Efficacy of Exenatide
Injection in Subjects with Type 2 Diabetes Mellitus