FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2017/06/008830 [Registered on: 14/06/2017] Trial Registered Prospectively
Last Modified On: 29/11/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A Trial to determine the Efficacy and Safety of Oral Semaglutide versus Placebo in Subjects diagnosed with Type 2 Diabetes Mellitus treated with insulin 
Scientific Title of Study   "Efficacy and Safety of Oral Semaglutide versus Placebo in Subjects with Type 2 Diabetes Mellitus treated with insulin"  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
1111-1180-3637  UTN 
NN9924-4280, Amendment No -2,version -3.0, dated 22 Nov 2016  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
Modification(s)  
Name  Dr Anil N Shinde 
Designation  Director- Clinical, Medical, Regulatory & Quality 
Affiliation  Novo Nordisk India Private Ltd. 
Address  Novo Nordisk India Private Ltd. Plot No.32, 47 - 50, EPIP Area, Whitefield, Bangalore.

Bangalore
KARNATAKA
560066
India 
Phone  91-8040303471  
Fax  8041123517  
Email  ansd@novonordisk.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Dr Anil N Shinde 
Designation  Director- Clinical, Medical, Regulatory & Quality 
Affiliation  Novo Nordisk India Private Ltd. 
Address  Novo Nordisk India Private Ltd. Plot No.32, 47 - 50, EPIP Area, Whitefield, Bangalore.

Bangalore
KARNATAKA
560066
India 
Phone  91-8040303471  
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 India Private Ltd  
Address  Novo Nordisk India Private Ltd. Plot No.32, 47 - 50, EPIP Area, Whitefield, Bangalore - 560 066, India 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India
Japan
Mexico
Poland
Russian Federation
United States of America
Canada
France
Greece  
Sites of Study
Modification(s)  
No of Sites = 12  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Yashdeep Gupta   All India Institute of Medical Sciences  Department of Endocrinology & Metabolism, 3RD Floor, Biotechnology Building All India Institute of Medical Sciences New Delhi, 11029, India
New Delhi
DELHI 		 9999598468

yash_deep_gupta@yahoo.co.in 
Dr Sanjay Chatterjee  Apollo Gleneagles Hospitals  Clinical Trial & Research Department 58, Canal Circular Road, Kolkata-700054, West Bengal, India"
Kolkata
WEST BENGAL 		 9831032310
03323201739
sanjay_doc@yahoo.co.in 
Dr Banshi Saboo  Dr. Jivraj Mehta Health Foundation Bakeri Medical Research Center,  Endocrine OPD, Ayojannagar, Near Shreyas crossing Road Jivraj Mehta Marg, Jivrajpark Ahmedabad – 380007, Gujarat"
Ahmadabad
GUJARAT 		 9824047676
07926302104
banshisaboo@hotmail.com 
Dr Neeraj Manikath   Government Medical College  Medical College Rd, Government Medical College Campus, Kozhikode, Kerala 673009
Kozhikode
KERALA 		 9447391055

nmanikath@gmail.com 
Dr Sanjay Agarwal  Grand medical Foundation Ruby Hall Clinic  40, Sassoon Road, Pune- 411001, Maharashtra"
Pune
MAHARASHTRA 		 9822091220
02066455628
agarwalclinic@gmail.com 
Dr Subhankar Chowdhury  IPGME&R and SSKM Hospital  "Dept. of Endocrinology, IPGME&R and SSKM Hospital, Ronald Ross Building, 4th Floor, 244 AJC Bose Road, Kolkata 700 020.
Kolkata
WEST BENGAL 		 9831076501
03322235076
subhankar.chowdhury@gmail.com 
DrVMohan  Madras Diabetes Research Foundation  Clinical trials Department 1st floor #8, Conran Smith Road, Gopalapuram, Chennai-600086"
Chennai
TAMIL NADU 		 4443968888
04428350935
drmohans@diabetes.ind.in 
DrArpandev Bhattacharyya  Manipal Hospital  "Dept. Of Diabetes & Endocrinology,"Dept. Of Diabetes & Endocrinology, Manipal Hospital, 98, HAL Airport Road, Bangalore – 560017, Karnataka, India " 98, HAL Airport Road, Bangalore – 560017, Karnataka, India
Bangalore
KARNATAKA 		 9886051410
08025207181
arpan@diabetesendocrinology.in 
Dr Shaikh Shehla Sajid Akhtar  Prince Aly Khan Hospital  Aminabad Building, 4th Flr, Flat no 25, Aga Hall, Nesbit Road,Mazagaon, Mumbai 400 010 India
Mumbai
MAHARASHTRA 		 9820984842
02223743820
drshehla@rediffmail.com 
Dr Sandeep Kumar Mathur  SMS Medical College & Attached Hospitals  Dhanwantri OPD Block, First Floor,Room no- J.L.N. Marg, Jaipur - 302004 Rajasthan - India
Jaipur
RAJASTHAN 		 01412560291

drsandeepmathur@rediffmail.com 
Dr Premlata Krishnamoorthy Varthakavi  Topiwala National Medical College & BYL Nair Charitable Hospital,  Department of Endocrinology, College building, 4th Floor, Room no. 19, Topiwala National Medical College & BYL Nair Charitable Hospital, Dr AL Nair Road, Mumbai- 400 008,Maharashtra, India
Mumbai
MAHARASHTRA 		 9224480560

premavar@hotmail.com 
Dr Sunil M Jain  Totall Diabetes Hormone Institute  A unit of Diabetes Thyroid Hormone Research Institute Pvt Ltd, BCM Health Island, PU4, Scheme 54, Behind Prestige Management Institute, Near Bombay Hospital, Indore – 452010.
Indore
MADHYA PRADESH 		 7312443200
7312443250
sunilmjain@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 11  
Name of Committee  Approval Status 
Prince Aly Khan hospital Institutional Ethics Committee  Approved 
Dr. Jivraj Mehta Smarak Health Foundation Bakeri Medical Research Center Institutional Ethics committee   Approved 
Ethics Committee of Diabetes Thyroid hormone research institute  Approved 
Ethics Committee of Manipal Hospitals  Approved 
Institutional Ethics Committee Poona Medical Research Foundation  Approved 
Institutional Ethics Committee, AIIMS  Approved 
Institutional Ethics committee, Apollo Gleneagles Hospitals  Approved 
Institutional Ethics Committee, Govt. Medical College  Approved 
Institutional Ethics Committee, IPGME&R and SSKM Hospital  Approved 
Institutional Ethics Committee, Madras Diabetes Research Foundation  Approved 
The Ethics Committee, S.M.S Hospital  Not Applicable 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Type 2 Diabetes, (1) ICD-10 Condition: E11||Type 2 diabetes mellitus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Oral Semaglutide   Once daily dose of 3mg, 7mg and 14mg of oral semaglutide Total duration 52 week 
Comparator Agent  Placebo  Once daily dose of 3mg, 7mg and 14mg of placebo orally Total duration 52 week 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1Informed 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.

2Male or female, age above or equal to 18 years at the time of signing informed consent.

3Diagnosed with type 2 diabetes mellitus ≥ 90 days prior to the day of screening.

4HbA1c of 7.0-9.5 percentage(53-80 mmol/mol) (both inclusive).

5Stable treatment with one of the following insulin regimens (minimum 10 IU/day) ≥ 90 days prior to the day of screening. Maximum 20% change in total daily dose is acceptable:
1Basal insulin alone
2Basal and bolus insulin in any combination
3Premixed insulin including combinations of soluble insulins
4Concomitant treatment with stable daily dose of metformin (≥ 1500 mg or maximum tolerated dose as documented in the subject medical record) ≥ 90 days prior to the day of screening is allowed.  
 
ExclusionCriteria 
Details  1Known or suspected hypersensitivity to trial product(s) or related products.
2Previous participation in this trial. Participation is defined as signed informed consent.
3Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice).
4Receipt of any investigational medicinal product within 90 days before screening.
5Any disorder, which in the investigator’s opinion might jeopardise subject’s safety or compliance with the protocol.
6Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN 2) or Medullary Thyroid Carcinoma (MTC).
7History of pancreatitis (acute or chronic).
8History of major surgical procedures involving the stomach and potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery).
9Any of the following: myocardial infarction (MI), stroke or hospitalisation for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening and randomisation.
10Classified as being in New York Heart Association (NYHA) Class IV.
11Planned coronary, carotid or peripheral artery revascularisation known on the day of screening.
12Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) <60 mL/min/1.73 m2 as per Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI).
13Treatment 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 change of insulin treatment for acute illness for a total of ≤ 14 days.
14Known hypoglycaemic unawareness according to Clarke’s questionnaire.
15Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within 90 days prior to randomisation.
16History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and carcinoma in situ).
17Subjects with alanine aminotransferase (ALT) > 2.5 x upper normal limit (UNL). 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Change from baseline in HbA1c
 		 Week 0 to week 26
 
 
Secondary Outcome  
Outcome  TimePoints 
Change from baseline to week 26 in body weight   Week 0 to week 26 
Change from baseline to week 52 in:
1HbA1c
2Body weight (kg)  		 Week 0 to week 52 
Change from baseline to week 26 and week 52 in:
1Fasting plasma glucose (FPG) 		 Week 0 to week 26 and week 52 
If a subject after week 26 and week 52 achieves HbA1c 7.0% (53 mmol/mol)   Week 0 till after week 26 and week 52  
Number of treatment-emergent adverse events (TEAEs) and Systamatic Hypoglycaemic episodes during exposure to trial product, assessed
up to approximately 57 weeks 		 Week 0 to week 57 
 
Target Sample Size   Total Sample Size="720"
Sample Size from India="80" 
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 3 
Date of First Enrollment (India)   15/06/2017 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  02/01/2017 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="1"
Days="21" 
Recruitment Status of Trial (Global)
Modification(s)  		 Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  


This trial is conducted globally. This is a 52-week, randomised, double-blind, placebo-controlled, four-armed, parallel-group, multicentre, multinational trial. The trial will compare the efficacy and safety of three dose levels of once-daily oral semaglutide versus placebo in subjects with T2DM treated with insulin. The total trial duration for the individual subject will be approximately 59 weeks. The trial includes a 2-week screening period followed by a 52-week randomised treatment period and a 5-week follow-up period.


 
Close