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CTRI Number  CTRI/2017/07/008990 [Registered on: 06/07/2017] 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   This trial will study if it is beneficial in terms of blood sugar control, and safe, to add liraglutide to anti-diabetes medication like sodium-glucose co- transporter 2 (SGLT2) inhibitor with or without metformin.  
Scientific Title of Study   "This is a 26-week, confirmatory, randomised, double-blind, placebo-controlled, multicentre, multinational, two-arm, parallel-group trial, investigating the effect and safety of adding liraglutide 1.8 mg/day to pre-trial treatment with any SGLT2 inhibitor (as monotherapy or in combination withmetformin) in subjects with T2DM who have not achieved adequate glycaemic control despite stable treatment with SGLT2 inhibitor ± metformin for at least 90 days prior to trial participation. "  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NN2211-4315 version 2.0 dated 26 Oct 2016  Protocol Number 
U1111-1184-8086  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
Modification(s)  
Name  Dr Anil N Shinde 
Designation  Director – Clinical, Medical, Regulatory Affairs & Quality (CMRQ) 
Affiliation  Novo Nordisk India Private Ltd. 
Address  Novo Nordisk India Private Ltd. Plot No.32, 47 - 50 EPIP Area, Whitefield Bangalore Karnataka 560066 India

Bangalore
KARNATAKA
560066
India 
Phone  91-8040303471  
Fax  08041123517  
Email  ansd@novonordisk.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Dr Anil N Shinde 
Designation  Director – Clinical, Medical, Regulatory Affairs & Quality (CMRQ) 
Affiliation  Novo Nordisk India Private Ltd 
Address  Novo Nordisk India Private Ltd. Plot No.32, 47 - 50 EPIP Area, Whitefield Bangalore Karnataka 560066 India

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 Karnataka 560 066  
 
Primary Sponsor  
Name  Novo Nordisk India Private Ltd 
Address  Plot No.32, 47 - 50, EPIP Area, Whitefield" Bangalore Karnataka 560 066  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Argentina
Brazil
Canada
India
Ireland
Italy
Lebanon
Malaysia
Mexico
Sweden
United Kingdom
United States of America  
Sites of Study  
No of Sites = 9  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr D Vijay Shekhar Reddy  Gandhi Medical College and Hospital  Department of Endocrinology, 3rd Floor, Main Building, Musheerabad, Secunderabad, Telangana 500003
Hyderabad
ANDHRA PRADESH 		 9849172161
04027504441
drdvsreddyendo@yahoo.com 
Dr Leena Ashwin Dabhi  AMC MET Medical College Sheth L. G. General Hospital  Research Room Opp. (Old) X-Ray Room and Radiology Department, Near Medicine Department OPD, Ground Floor, Old Building, Rambag, Maninagar, Ahmedabad Gujurat 380008
Ahmadabad
GUJARAT 		 9879144653
917925464653
leenadabhilg@gmail.com 
Dr Vaishali Deshmukh  Deenanath Mangeshkar Hospital and research centre  Near Mhatre Bridge, Erandawne Pune Maharastra 411004
Pune
MAHARASHTRA 		 9850811450
02040151668
deshmukhclinic@rediffmail.com 
Dr S K Sharma  Diabetes, Thyroid and Endocrine centre  A1,Ajmer Road, near 4no, ESI Hospital,Jaipur, Rajasthan -302006
Jaipur
RAJASTHAN 		 9829010233
01412451947
sksharmacr@gmail.com 
Dr A K Ojha  ILS  Salt Lake City, Kolkata, West Bengal 700064
Kolkata
WEST BENGAL 		 9831833197
03340206555
ojha_arvind2003@yahoo.co.in 
DrBalamurugan Ramanathan  Kovai Diabetic Speciality Centre & Hospital  No.15, Vivekananda Road, Shop No.15, Vivekananda Rd, Ram Nagar Coimbatore Tamil Nadu 641009
Coimbatore
TAMIL NADU 		 9842244881
04224377714
balamurugan_dr@gmail.com 
Dr S K Jain  Lady Hardinge Medical College and S.S.K. Hospital  Department of Medicine First Floor, Old Building, Lady Hardinge Medical College and S.S.K. Hospital, New Delhi-110001
New Delhi
DELHI 		 9811411214
01123363728
sjajnj@yahoo.com 
Dr Arpandev Bhattacharyya  Manipal Hospitals  98, HAL Airport Road Bangalore Karnataka 560017
Bangalore
KARNATAKA 		 9886051410
08025207181
arpan@diabetesendocrinology.in 
Dr Sunil M Jain  TOTALL Diabetes Hormone Institute  BCM Health Island PU-4 Scheme No. 54, Near Bombay Hospital, Behind Prestige Management Institute, Indore Madhya Pradesh 452010
Indore
MADHYA PRADESH 		 9826023182
917312443250
drmeghaagrawal@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 9  
Name of Committee  Approval Status 
AMC MET Ethics Committee  Approved 
Ethics Committee for Human Research Lady Hardinge Medical College and S.S.K. Hospital  Approved 
Ethics Committee of Diabetes Thyroid Hormone Research Institute  Approved 
Ethics Committee of Manipal Hospitals  Approved 
Human Welfare Ethical Committee for Human Sciences and Research  Approved 
ILS Hospital Ethics Committee  Approved 
Institutional Ethics Committee Gandhi Medical College and Hospital  Approved 
Institutional Ethics Committee of Kovai Diabetes Specialty Centre and Hospital  Approved 
Institutional Ethics Committee(IEC) Department of Research 6th Floor C Wing Deenanath Mangeshkar Hospital and Research Centre   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Type 2 Diabetes,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Liraglutide   Liraglutide will be initiated with a starting dose of 0.6 mg/day, with subsequent weekly dose escalations of 0.6 mg/day in accordance with the approved dose escalation for liraglutide until the maintenance dose of 1.8 mg/day in this trial is reached. Escalation from 0.6 to 1.2 then 1.8 mg/day can be extended by 7 days in total if subjects do not tolerate an increase in dose during dose escalation, at the discretion of the investigator. duration : 29 weeks route of administration: subcutaneous 
Comparator Agent  Placebo  Placebo will be initiated with a starting dose of 0.6 mg/day, with subsequent weekly dose escalations of 0.6 mg/day in accordance with the approved dose escalation for liraglutide until the maintenance dose of 1.8 mg/day in this trial is reached. Escalation from 0.6 to 1.2 then 1.8 mg/day can be extended by 7 days in total if subjects do not tolerate an increase in dose during dose escalation, at the discretion of the investigator. duration : 29 weeks route of administration: subcutaneous 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  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.
3. Diagnosed with type 2 diabetes mellitus.
4. HbA1c of 7.0-9.5% (53-80 mmol/mol) (both inclusive).
5. Stable dose of an SGLT-2 inhibitor as monotherapy or in combination (including fixed-dose
drug combination) with a stable dose of metformin (≥ 1500 mg or maximum tolerated dose)
for at least 90 days prior to the day of screening. All medications in compliance with current
local label.
6. Body mass index greater than 20 kg/m2."
 
 
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 an adequate contraceptive method (adequate contraceptive measure
as required by local regulation or practice).Brazil: According to resolution 466/12: Regarding exclusion criterion: Female who is
pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not
using adequate contraceptive methods (adequate contraceptive measures as required by local
regulation or practice). For women who expressly declare free of the risk of pregnancy, either
by not engaging in sexual activity or by having sexual activity with no birth potential risk, use of
contraceptive method will not be mandatory.
4. Receipt of any investigational medicinal product within 90 days before screening.
5. Treatment with any medication for the indication of diabetes or obesity other than stated in
the inclusion criteria within the past 90 days prior to the day of screening. However, short
term insulin treatment for a maximum of 14 days during the 90 days prior to the day of
screening is allowed.
6. Any disorder which in the investigator’s opinion might jeopardise subject’s safety or
compliance with the protocol.
7. History of diabetic ketoacidosis while being treated with SGLT2 inhibitors.
8. Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid
carcinoma. Family is defined as a first degree relative.
9. History or presence of pancreatitis (acute or chronic).
10. Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of < 60
mL/min/1.73m2 as defined by KDIGO1 classification using isotope dilution mass
spectrometry (IDMS) for serum creatinine measured at screening.
11. Impaired liver function, defined as ALT ≥2.5 times upper normal limit at screening.
12. Subjects presently classified as being in New York Heart Association (NYHA) Class IV.
13. Planned coronary, carotid or peripheral artery revascularisation known on the day of
screening.
14. Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or
transient ischaemic attack within the past 180 days prior to the day of screening.
15. Inadequately treated blood pressure defined as Grade 3 hypertension or higher (systolic
≥180 mmHg or diastolic ≥110 mmHg) at screening.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
To compare the effect of liraglutide 1.8 mg/day versus placebo as add-on to an SGLT2 inhibitor ± metformin on glycaemic control in subjects with type 2 diabetes mellitus.
 		 Change from baseline to week 26  
 
Secondary Outcome  
Outcome  TimePoints 
To compare the effect of liraglutide 1.8 mg/day versus placebo as add-on to an SGLT2 inhibitor ±
metformin in subjects with type 2 diabetes mellitus with regards to:
Body weight related parameters
Selected cardiovascular risk factors
Safety 		 Change from baseline to week 26 in body weight
 
To compare the effect of liraglutide 1.8 mg/day versus placebo as add-on to an SGLT2 inhibitor ±
metformin in subjects with type 2 diabetes mellitus with regards to:
selected glucose metabolism parameters 		 Change from baseline to week 26 in body weight 
 
Target Sample Size   Total Sample Size="303"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "398"
Final Enrollment numbers achieved (India)="31" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   19/07/2017 
Date of Study Completion (India) 08/05/2018 
Date of First Enrollment (Global)  03/03/2017 
Date of Study Completion (Global) 01/06/2018 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
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 26-week, confirmatory, randomised, double-blind, placebo-controlled, multicentre,
multinational, two-arm, parallel-group trial, investigating the effect and safety of adding liraglutide
1.8 mg/day to pre-trial treatment with any SGLT2 inhibitor (as monotherapy or in combination with
metformin) in subjects with T2DM who have not achieved adequate glycaemic control despite
stable treatment with SGLT2 inhibitor ± metformin for at least 90 days prior to trial participation.
 
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