FULL DETAILS (Read-only)

CTRI Number  CTRI/2016/08/007216 [Registered on: 23/08/2016] 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, Active Controlled Trial 
Public Title of Study
Modification(s)  
A clinical trial to compare the glycaemic control and safety of insulin degludec/liraglutide (IDegLira) with insulin glargine (IGlar) as add-on therapy to SGLT2i in subjects with type 2 diabetes mellitus  
Scientific Title of Study   A clinical trial comparing glycaemic control and safety of insulin degludec/liraglutide (IDegLira) versus insulin glargine (IGlar) as add-on therapy to SGLT2i in subjects with type 2 diabetes mellitus  
Secondary IDs if Any
Modification(s)  
Secondary ID  Registry 
NN9068-4229 ver 2.0 dated 20 NOV 15  Protocol Number 
U1111-1168-9343  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Address 




 
Phone    
Fax    
Email    
 
Details Contact Person
Scientific Query

Modification(s)  
Name  Dr Anil N Shinde 
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 Contact Person
Public Query

Modification(s)  
Name  Dr Anil N Shinde 
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  
 
Source of Monetary or Material Support  
Novo Nordisk India Private Ltd.  
 
Primary Sponsor  
Name  Novo Nordisk India Private Ltd 
Address  Plot No.32, 47 - 50, EPIP Area, Whitefield, Bangalore.  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Argentina
Canada
Finland
Hungary
India
Russian Federation
Slovakia
Slovenia
Spain
Switzerland
United States of America  
Sites of Study  
No of Sites = 8  
Contact Person  Name of Site  Site Address  Phone/Fax/Email 
Dr JJ Mukherjee  Apollo Gleneagles Hospitals   Endocrinology & Diabetes Department Apollo Gleneagles Hospitals Kolkata, 58 – canal Circular Road Kolkata- 700054.
Kolkata
 
03323203040
03323205184
jjmukh@gmail.com 
Dr S K Singh  Banaras Hindu University  Dept. of Endocrinology and metabolism Institute of medical sciences,Banaras Hindu University Varanasi, Uttar Pradesh -221 005
Varanasi
 
05422307528
05422367568
sksendocrine@yahoo.com 
Dr Parminder Singh   Dayanand Medical College & Hospital  Dept of Endocrinology DMC&H Civil Lines, Tagore Nagar Ludhiana -141001 Punjab
Ludhiana
 
0161-4687700

pam.endo@yahoo.co.in 
Dr V Balaji   Dr v. Seshiah Diabetes Research Institute   729, P.H Road, Aminjikarai , Chennai -600029 Tamil Nadu
Chennai
 
04426641414
04426640660
balajivijayam@gmail.com 
Dr Rakesh Sahay  Osmania medical College & general Hospital   Dept of Endocrinology 2nd Floor, Golden Jubilee Block Osmania medical College & general Hospital Afzalgunj, HYDERABAD Telangana – 500012
Hyderabad
 
04024651667
04024651667
sahayrk@gmail.com 
Dr Sushil Jindal   People’s College of Medical Science’s & Research centre  Bypass Road, Bhanpur, Bhopal 462037, Madhya Pradesh, India.
Bhopal
 
9300033888

susjindal@gmail.com 
Dr Deep Dutta  PGIMER & Dr RML Hospital   Room no. 36, Guest House cum Academic block, PGIMER Annex, 1, Baba Kharak Singh Marg , New Delhi 110001
New Delhi
 
9911544096

pratibhase111@gmail.com 
Dr Sandeep Mathur   SMS Medical College & Attached Hospitals  Dhanwantri OPD Block , First Floor JLN MARG , Jaipur- 302004
Jaipur
 
01412708666

drsandeepmathur@rediffmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 8  
Name of Committee  Approval Status 
Drug Trial Ethics committee  Approved 
Ethics Committee Institute of Medical Sciences situated at Faculty of Medicine Banaras Hindu University  Not Applicable 
Ethics Committee of Apollo Gleneagles Hospitals   Approved 
Ethics Committee of Osmania Medical College& Osmania General Hospital   Approved 
Ethics Committee of People’s College of Medical Sciences & Research Centre   Approved 
Institutional Ethics committee of PGIMER & Dr RML Hospital   Not Applicable 
The Ethics Committee of Dr V. Seshiah Diabetes Research Institute   Approved 
The Ethics Committee of SMS Medical college & Attached Hospitals   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Type 2 Diabetes 
Patients  Type 2 diabetes mellitus 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Insulin Degludec/Liraglutide   Starting dose of 10 dose steps (10 Units Insulindegludec+ 0.36 mg Liraglutide) / 26 weeks/ Once daily Injection / Subcutaneous  
Comparator Agent  Insulin glargine   Starting dose of 10 Units (10 Units Insulin Glargine) / 26 weeks/ Once daily Injection / Subcutaneous  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 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 greater than or equal to 18 years at the time of signing informed consent.
3. Subjects diagnosed (clinically) with type 2 diabetes mellitus.
4. HbA1c 7.0-11.0% (53-97 mmol/mol) (both inclusive) by central laboratory analysis.
5. BMI greater than or equal to 20 kg/m2 and lesser than 40 kg/m2.
6. Insulin naïve subjects; however short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as well as prior insulin treatment for gestational diabetes.
7. Oral antidiabetic treatment:
a. SGLT2i: Subjects must have been on a stable daily dose of any SGLT2i (greater than or equal to half of the maximum approved dose according to current local label or maximum tolerated dose as documented in subject medical record, or minimum recommended maintenance dose according to current local label) for at least 90 days prior to the day of screening.
b. Combination therapy: Stable daily dose of SGLT2i as outlined above in combination with stable daily dose(s) of metformin with/without DPP4i is allowed:
i. Metformin (greater than or equal to 1500 mg or maximum tolerated dose as documented in the subject medical record) for at least 90 days prior to the day of screening.
ii. DPP4i (greater than or equal to half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record) for at least 90 days prior to the day of screening.
iii. Stable daily doses, as outlined above, of fixed dose combination products combining either SGLT2i and metformin or SGLT2i and DPP4i, according to locally approved label for at least 90 days prior to the day of screening are also allowed 
 
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. Receipt of any investigational medicinal product within 90 days prior to screening.
4. 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).
5. Use of any OADs (other than SGLT2i in monotherapy or in combination with metformin or DPP4i or pioglitazone as described in the inclusion criteria) within 90 days prior to the day of screening.
6. Use of GLP-1 receptor agonist (e.g., exenatide or liraglutide) within 90 days prior to the day of screening.
7. Acute decompensation of glycaemic control requiring immediate intensification of treatment to
prevent severe metabolic dysregulation (e.g., diabetes ketoacidosis) in the previous 90 days prior to the day of the screening.
8. Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroids carcinoma.
9. Screening calcitonin ≥ 50 ng/L.
10. History of pancreatitis (acute or chronic).
11. Any of the following: myocardial infarction, stroke or hospitalisation for unstable angina and/or
transient ischaemic attack within the past 180 days prior to the day of screening.
12. Subjects presently classified as being in NYHA Class III or IV.
13. Planned coronary, carotid or peripheral artery revascularisation at the day of screening.
14. Renal impairment eGFR 60 mL/min/1.73 m2 as per CKD-EPI.
15. Impaired liver function, defined as ALT ≥ 2.5 times upper normal limit at screening.
16. Inadequately treated blood pressure as defined as Class 2 hypertension or higher (systolic ≥ 160
mmHg or diastolic ≥ 100 mmHg) at screening.
17. Anticipated initiation or change in concomitant medications for more than 14 consecutive days or on a frequent basis known to affect weight or glucose metabolism (e.g., orlistat, thyroid hormones, corticosteroids).
18. Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within 90 days prior to randomisation.
19. History or presence of malignant neoplasms within the last 5 years (except basal and squamous
cell skin cancer and in-situ carcinomas).
20. History of diabetic ketoacidosis.
21. Any disorder, except for conditions associated with diabetes, which in the investigator’s opinion
might jeopardise subject’s safety or compliance with the protocol.
"
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change from baseline in HbA1c
 
Week 0 to week 26 
 
Secondary Outcome  
Outcome  TimePoints 
1. Change from baseline in body weight after 26 weeks
2. Number of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during 26 weeks
3. Insulin dose, total daily dose (U)
 
Week 0 to week 26 
 
Target Sample Size   Total Sample Size="416"
Sample Size from India="50" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   26/08/2016 
Date of First Enrollment (Global)  23/05/2016 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Brief Summary  
This is a 26-week randomised, active-controlled, multicentre, multinational, two-arm parallel, openlabel, TTT trial in subjects with T2DM. Subjects inadequately controlled on treatment with SGLT2i ± OAD will be eligible for the trial. The trial will compare IDegLira to IGlar as an add-on to treatment with SGLT2i ± OAD. Inadequately controlled T2DM is defined as an HbA1c level of 7.0-11.0 % (53-97 mmol/mol) (both inclusive).  A total of 416 subjects will be randomized using IWRS in a 1:1 manner to either of the two trial arms, IDegLira (OD) or IGlar (OD).
The total trial duration will be approximately 32 weeks, consisting of a 2 week screening period, a 26-week treatment period, and two follow-up contacts (FU1 and FU2).

 

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
Modification(s)  
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. "  
Secondary IDs if Any  
Secondary ID  Registry 
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   
Address 




 
Phone    
Fax    
Email    
 
Details Contact Person
Scientific Query

Modification(s)  
Name  Dr Anil N Shinde 
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 Contact Person
Public Query

Modification(s)  
Name  Dr Anil N Shinde 
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
Modification(s)  
No of Sites = 9  
Contact Person  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
 
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
 
9879144653
917925464653
leenadabhilg@gmail.com 
Dr Vaishali Deshmukh  Deenanath Mangeshkar Hospital and research centre  Near Mhatre Bridge, Erandawne Pune Maharastra 411004
Pune
 
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
 
9829010233
01412451947
sksharmacr@gmail.com 
Dr A K Ojha  ILS  Salt Lake City, Kolkata, West Bengal 700064
Kolkata
 
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
 
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
 
9811411214
01123363728
sjajnj@yahoo.com 
Dr Arpandev Bhattacharyya  Manipal Hospitals  98, HAL Airport Road Bangalore Karnataka 560017
Bangalore
 
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
 
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
Modification(s)  
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
Modification(s)  
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
Modification(s)  
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" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)
Modification(s)  
19/07/2017 
Date of First Enrollment (Global)  03/03/2017 
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
Modification(s)  
None yet 
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.
 

CTRI Number  CTRI/2017/06/008819 [Registered on: 12/06/2017] Trial Registered Prospectively
Last Modified On: 09/06/2017
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study
Modification(s)  
Drug 
Study Design  Single Arm Trial 
Public Title of Study
Modification(s)  
Is SGLT2 inhibitors(diabetes drug) effective?:Test on exfoliated human kidney cell.  
Scientific Title of Study   SGLT2 EXPRESSION IN HUMAN RENAL PROXIMAL TUBULAR CELLS FOR PREDICTING EFFICACY OF SGLT2 INHIBITORS 
Secondary IDs if Any  
Secondary ID  Registry 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sujoy Ghosh 
Address  Institute of post graduate medical education and research and SSKM hospital 244 AJC Bose road kolkata 700020 Ronald Ross Building 4th floor room no 8 Department of Endocrinology and Metabolism

Kolkata
WEST BENGAL
700020
India 
Phone  9674625823  
Fax  03322236558  
Email  drsujoyghosh2000@gmail.com  
 
Details Contact Person
Scientific Query
 
Name  Dr Sujoy Ghosh 
Address  Institute of post graduate medical education and research and SSKM hospital 244 AJC Bose road kolkata 700020 Ronald Ross Building 4th floor room no 8 Department of Endocrinology and Metabolism


WEST BENGAL
700020
India 
Phone  9674625823  
Fax  03322236558  
Email  drsujoyghosh2000@gmail.com  
 
Details Contact Person
Public Query
 
Name  Dr Sujoy Ghosh 
Address  Institute of post graduate medical education and research and SSKM hospital 244 AJC Bose road kolkata 700020 Ronald Ross Building 4th floor room no 8 Department of Endocrinology and Metabolism


WEST BENGAL
700020
India 
Phone  9674625823  
Fax  03322236558  
Email  drsujoyghosh2000@gmail.com  
 
Source of Monetary or Material Support
Modification(s)  
Research Society for the Study of Diabetes in India,Dr Makkars Diabetes and Obesity Centre A 5 B/122 Paschim Vihar New Delhi 110063 India  
 
Primary Sponsor  
Name  Research Society for the Study of Diabetes in India 
Address  Dr Makkars Diabetes and Obesity Centre A 5 B/122 Paschim Vihar New Delhi 110063 India 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 1  
Contact Person  Name of Site  Site Address  Phone/Fax/Email 
Dr Sujoy Ghosh  Institute of post graduate medical education and research and SSKM hospital  Department of Endocrinology,Ronald ross building,room-8 244 AJC Bose road kolkata 700020
Kolkata
 
9674625823
03322236558
drsujoyghosh2000@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IPGME&R RESEARCH OVERSIGHT COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
Awaited 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Type 2 Diabetes mellitus prediabetes 
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  Canagliflozin  Canagliflozin 100mg once daily orally will be given in both groups of type 2 diabetes patients (both with glucose levels between 180-250 mg/dl). Group 1: with Glycosuria at baseline. Group 2: without Gylcosuria at baseline. Glycaemic response in both groups will be compared and also corroborated with expression of SGLT2 receptor at baseline and after intervention.  
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Healthy subjects- normoglycaemic (Fasting glucose <100mg/dl) and 2hr Post 75gm glucose, plasma venous glucose <140 mg/dl.
Individuals with prediabetes: (Fasting glucose <100mg/dl but <126 mg/dl) and/or 2hr Post 75gm glucose, plasma venous glucose >140 mg/dl but < 200 mg/dlType2 Diabetes as per ADA criteria, on lifestyle modification and drugs (other than SGLT2 inhibitors) but with current venous plasma glucose levels (fasting, 2 hour post prandial and/or random) greater than 180mg/dl but less than 250mg/dl
 
 
ExclusionCriteria 
Details  • Prior SGLT2 inhibitor therapy in last 6 months
• Individuals on insulin therapy
• Contraindications to SGLT2 inhibitor therapy
• Comorbidities requiring hospital admission including CVA, CAD, CKD, dialysis, surgery, pregnancy, lactation, or complications arising thereof.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
This study will be first of its kind to help us to define If SGLT2/GLUT2 is overexpressed in Indians with Type 2 Diabetes and/or individuals with pre-diabetes.
This will provide pathophysiological basis for prediction of treatment benefit with SGLT2 inhibitors in Indians.
This study is likely to provide clinical insights into patient characteristics which help predict response to SGLT2 inhibitors (example presence or absence of glycosuria.

 
1year 
 
Secondary Outcome  
Outcome  TimePoints 
This will provide pathophysiological basis for prediction of treatment benefit with SGLT2 inhibitors in Indians.
This study is likely to provide clinical insights into patient characteristics which help predict response to SGLT2 inhibitors (example presence or absence of glycosuria.

 
1year 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/07/2017 
Date of First Enrollment (Global)  No Date Specified 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details
Modification(s)  
none yet 
Brief Summary  

Diabetes mellitus is estimated to affect nearly 350million of the  global population and predicted to affect over 550million by 2035. In healthy (ie, glucose-tolerant) individuals, approximately 160–180 grams of glucose from plasma is filtered by the kidneys daily. Renal glucose homeostatsis includes gluconeogenesis, glucose uptake from circulation for metabolism by kidney and renal glucose filtration followed by reabsorption. Bulk of filtered glucose i.e.90% is reabsorbed by the low-affinity/high-capacity sodium glucose co-transporter (SGLT2) located in the S1 segments of proximal tubule and residual glucose is then absorbed by the high-affinity/low-capacity SGLT1 in the S3 segment. Transcellular glucose transport is facilitated by two basolateral membrane glucose transporters: the low-affinity GLUT2 in the S1 segment and the high-affinity GLUT1 in the S3 segment. Hence almost no glucose is excreted into the urine in normoglycaemic individuals. In a healthy adult, the maximum glucose transport capacity known as the renal threshold for glucose equates to a filtration rate of 260–350 mg/min/1.73 m2, which is equivalent to a plasma glucose concentration of approximately 180 mg/dL. Once this threshold is exceeded extra glucose cannot be reabsorbed and is excreted into the urine, resulting in glycosuria.In previous studies it has been suggested that the renal threshold in patient with uncontrolled diabetes may increase upto 250mg/dl,presumably due to upregulation of SGLT2. The filtered glucose load at glomerulus or glomerular filtration rate (GFR)is increased with hyperglycemia and diabetes is associated with glomerular hyperfiltration. A study in humans with type 1 diabetes showed a significant increase in the renal transport maximum (Tmax) of glucose , implying possible upregulation in tubular glucose carriers.Different studies have demonstrated that SGLT2 and tubular GLUT2 expressions were increased in alloxan induced and streptozotocin induced diabetic rats respectively. Human data regarding renal expression of SGLT2  and GLUT in diabetes is limited. Studies have demonstrated increased expression  ofintestinal glucose carriers in patients with type 2 diabetes. No studies have been conducted in individuals with pre-diabetes regarding expression of SGLT2 and GLUT2 in pre-diabetes in human renal proximal tubular cells.

In our study we would isolate and subculture highly differentiated proximal tubular epithelial cells from human urine. This technique, with its variations, is a significant new tool in understanding the expression and activity of renal glucose transporters in human proximal tubular epithelial cells from subjects with prediabetes, type 2 diabetes as compared to healthy volunteers. SGLT2 might be pathologically and demonstrably upregulated in PCT of prediabetics and diabetics as compared to normal subjects. It will also try to prove that glycosuria in diabetic and prediabetic subjects occurs due to upregulation of SGLT2, which may have variability (quantitative or qualitative) in expression due to differences with possible genetic polymorphism. Hence these subgroup of diabetics and prediabetics are much less likely to respond to SGLT2 inhibition than non glycosuric subjects. Thus, this study might ultimately have a huge impact in future in lowering the burden of medical expenditure regarding indiscriminate use of these costly group of drugs (SGLT2inhibitors) in clinical practice.

 

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