CTRI/2018/02/011670 [Registered on: 02/02/2018] Trial Registered Retrospectively
Last Modified On:
29/11/2018
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
This trial is to see Efficacy and long-term safety of oral semaglutide versus sitagliptin in subjects with type 2 diabetes
Scientific Title of Study
Efficacy and long-term safety of oral semaglutide versus sitagliptin in subjects with type 2 diabetes
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
NN9924-4222 ver 2.0 dated 24 Aug 2015
Protocol Number
U1111-1168-4339
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 Anil N Shinde
Designation
Associate Director- Clinical, Regulatory Affairs & Quality, Novo Nordisk India Pvt Ltd.
Affiliation
Novo Nordisk India Private Ltd.
Address
Novo Nordisk India Private Ltd.
Plot No.32, 47 - 50,
EPIP Area, Whitefield
Bangalore
Karnataka
560 006
Bangalore KARNATAKA 560 006 India
Phone
08040303200
Fax
08041123517
Email
ansd@novonordisk.com
Details of Contact Person Public Query
Name
Dr Anil N Shinde
Designation
Associate Director CMRQ
Affiliation
Novo Nordisk India Private Ltd.
Address
Novo Nordisk India Private Ltd.
Plot No.32, 47 - 50,
EPIP Area, Whitefield
Bangalore
Karnataka
560 006
Bangalore KARNATAKA 560 066 India
Phone
08040303200
Fax
08041123517
Email
ansd@novonordisk.com
Source of Monetary or Material Support
Novo Nordisk India Private Ltd.
Plot No.32, 47 - 50,
EPIP Area, Whitefield,
Bangalore - 560 066
India
Primary Sponsor
Name
Novo Nordisk AS
Address
Novo Nordisk India Private Ltd.
"Plot No.32, 47 - 50,
EPIP Area, Whitefield"
Bangalore
Karnataka
560 006
Type of Sponsor
Pharmaceutical industry-Global
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
Argentina Brazil France Germany India Israel Japan Mexico Romania Russian Federation South Africa Turkey Ukraine United Kingdom United States of America
Sites of Study
No of Sites = 24
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Yashdeep Gupta
All India Institute of Medical Sciences (AIIMS)
Department of Endocrinology & Metabolism, 3RD Floor, Biotechnology Building All India Institute of Medical Sciences
New Delhi
Delhi 110029
India
New Delhi DELHI
4th Floor, Room No. 19, Topiwala National Medical College & B.Y.L. Nair Charitable Hospital,
Dr. A. L. Nair Road,
Mumbai
Maharashtra 400 008
India Mumbai MAHARASHTRA
Care Hospital
CARE OUT PATIENT CENTRE, Ground Floor C Block, Room No. 125 8-2-620/A-E, Road No 10,Banjara Hills
Hyderabad
Telangana 500034
India Hyderabad ANDHRA PRADESH
04039310129 914066258792 sethibipin54@gmail.com
Dr Nihal Thomas
Christian Medical College (CMC)
810, Dept of Endocrinology, Diabetes and Metabolism, Christian Medical College
Vellore
Tamil Nadu 632004
India Vellore TAMIL NADU
Department of Endocrinology, NRS Medical College,
Kolkata,
West Bengal 700014,
India
Kolkata WEST BENGAL
919830176384
drnilanjansengupta@gmail.com
Dr Manoj Chadha
P. D. Hinduja Hospital
#2214,SECOND FLOOR , P.D.HINDUJA NATIONAL HOSPITAL AND MEDICAL RESEARCH CENTRE ,VEER SAVARKAR MARG,MAHIM(WEST ) Mumbai
Maharashtra 400016
India  Mumbai MAHARASHTRA
2224448242 02224441515 mchadha59@gmail.com
Dr Rajesh Rajput
PGIMS, Rohtak
Department of Endocrinology & Medicine VIÂ PGIMS, Medical Road, Rohtak,
Haryana 124001
India
Rohtak HARYANA
911262279069
drrajeshrajput@outlook.com
Dr Anil Bhansali
Post Graduate Institute of Medical Education & Research (PGIMER)
Sector 12, Near Punjab University
Chandigarh
Punjab 160012
India Chandigarh CHANDIGARH
KUKATPALLY
Hyderabad
Telangana 500072
India Hyderabad ANDHRA PRADESH
040-23320111
raopaturi@gmail.com
Dr Sushil Kumar Gupta
Sanjay gandhi post graduate institute of medical sciences(SGPGIMS),
Department of Medical Endocrinology, Sanjay gandhi post graduate institute of medical sciences(SGPGIMS), rae bareli road,
Lucknow,
Uttar pradesh-226014
INDIA
Lucknow UTTAR PRADESH
915222494918
sushilguptasgpgi@gmail.com
Dr Sandeep Mathur
SMS Hospital
Sawai Man Singh Hospital J.L.N. Marg, Near Narayan Singh Circle
Jaipur
Rajasthan 302004
India Jaipur RAJASTHAN
1. Informed consent obtained before any trial-related activities. Trial-related activities are any
procedures that are carried out as part of the trial, including activities to determine suitability for
the trial.
2. Male or female, age ≥ 18 years at the time of signing informed consent.
For Japan only: Male or female, age ≥ 20 years at the time of signing informed consent.
3. Diagnosed with type 2 diabetes mellitus ≥ 90 days prior to day of screening.
4. HbA1c 7.0-10.5% (53-91 mmol/mol) (both inclusive).
5. Stable daily dose of metformin (≥ 1500 mg or maximum tolerated dose as documented in the subject medical record) alone or in combination with SU (≥ half of the maximum approved dose according to local label or maximum tolerated dose as documented in the subject medical record) within 90 days prior to the day of screening.
ExclusionCriteria
Details
"1. Known or suspected hypersensitivity to trial product(s) or related products.
2. Previous participation in this trial. Participation is defined as signed informed consent.
3. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing
potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice).
4.Receipt of any investigational medicinal product within 90 days before screening. 5. Any disorder, which in the investigator’s opinion might jeopardise subject’s safety or compliance with the protocol.
6. Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN 2) or Medullary Thyroid Carcinoma (MTC).
7. History of pancreatitis (acute or chronic).
8. History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery).
9. Any of the following: myocardial infarction, stroke or hospitalization for unstable angina and/or transient ischaemic attack within the past 180 days prior to the day of screening.
10. Subjects presently classified as being in New York Heart Association (NYHA) Class IV.
11. Planned coronary, carotid or peripheral artery revascularisation known on the day of screening 12. Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) 60 mL/min/1.73 m2 as per Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI).
13. Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before the day of screening. An exception is short-term insulin treatment for acute illness for a total of ≤ 14 days.
14. Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within 90 days prior to randomisation.
15. History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in-situ carcinomas)."
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Primary Outcome
Outcome
TimePoints
Change in HbA1c values from baseline
Week 0 to Week 26
Secondary Outcome
Outcome
TimePoints
Change from baseline to week 26 in body weight (kg)
week 0 to week 26
Change in HbA1c and Body weight (kg)
From week 52 and to week 78
Change in:Body weight (%),FPG, SMPG, 7 point profile, Mean 7 point profile, Mean post prandial increment (over all meals), Body mass index (BMI),Waist circumference,Fasting lipid profile (total cholesterol, LDL cholesterol, VLDL cholesterol, HDL cholesterol,
triglycerides, free fatty acids,Patient reported outcomes,Short Form-36 version 2 (SF-36v2â„¢) (acute version) health survey
,Impact of Weight on Quality of Life (IWQoL-Lite) Clinical Trial Version, Control of Eating questionnaire (CoEQ)
from week 0 to week 26, to week 52 and to week 78
Subjects who after 26 weeks of treatment achieve(yes/no): HbA1c less than 7.0%(53 mmol/mol)ADA target,HbA1c ≤ 6.5%(48 mmol/mol) American Association of Clinical Endocrinologists target, HbA1c reduction ≥ 1%, Weight loss ≥ 3 %, Weight loss ≥ 5 %,Weight loss ≥ 10%, HbA1c less than 7.0%(53 mmol/mol) without hypoglycaemia (treatment emergent severe or BG confirmed symptomatic hypoglycaemia) and no weight gain, HbA1c reduction ≥ 1 % and weight loss ≥ 3 %
Week 0 to week 26 ,52 and 78
Target Sample Size
Total Sample Size="1852" Sample Size from India="150" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
This trial was unable to start in India due to unable to obtain Health Authority approval however this trial has been globally planned to complete on 26 Mar 2018. So this trial is terminated in India.