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CTRI Number  CTRI/2020/01/022846 [Registered on: 17/01/2020] Trial Registered Prospectively
Last Modified On: 19/11/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study the efficacy and safety of fixed dose combination of remogliflozin etabonate and vildagliptin in the treatment of type 2 diabetes mellitus. 
Scientific Title of Study   A randomised, double-blind, double-dummy, parallel-group, multi-centre, active-controlled study to evaluate efficacy and safety of fixed dose combination of remogliflozin etabonate and vildagliptin in subjects with type-2 diabetes mellitus. 
Trial Acronym  FOREVER  
Secondary IDs if Any  
Secondary ID  Identifier 
GPL/CT/2019/006/III, version no. 1.0, dated: 07.08.2019  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  
Name  Dr Rahul Kodgule 
Designation  GM-Clinical Development Branded Generics 
Affiliation  Glenmark Pharmaceuticals Ltd 
Address  Glenmark Pharmaceuticals Ltd Glenmark House, B D Sawant Marg Chakala, Andheri(East) District: Mumbai State: Maharashtra

Thane
MAHARASHTRA
400099
India 
Phone  912240189999  
Fax    
Email  Rahul.Kodgule@glenmarkpharma.com  
 
Details of Contact Person
Public Query  
Name  Amol Pendse 
Designation  DGM-Clinical Research Operations 
Affiliation  Glenmark Pharmaceuticals Ltd 
Address  Glenmark Research Centre, Plot No. A-607, T.T.C. Industrial Area, MIDC, Mahape, Navi Mumbai District: Thane State: Maharashtra

Thane
MAHARASHTRA
400709
India 
Phone  912267720000   
Fax    
Email  Amol.Pendse@glenmarkpharma.com  
 
Source of Monetary or Material Support  
Glenmark Pharmaceuticals Ltd. 
 
Primary Sponsor  
Name  Glenmark Pharmaceuticals Ltd 
Address  Glenmark House, B.D. Sawant Marg, Chakala, Andheri East, Mumbai State: Maharashtra PIN Code: 400099  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 28  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vipul Khandelwal  Apex Hospital Pvt.Ltd  Apex Hospital Pvt. Ltd, SP4 & 6, Malviya Industrial Area, Malviya nagar, Jaipur-302017
Jaipur
RAJASTHAN 		 9829193517

dr.vipul@yahoo.co.in 
Dr Arthur Joseph Asirvatham  Arthur Asirvatham Hospital  42-A, Kuruvikaran Salai, Near Anna Bus Stand, Madurai- 625020
Madurai
TAMIL NADU 		 91-9443751977

ajasirvathamresearch@yahoo.in 
Dr Paramesh Shamanna  Bangalore Diabetes Centre  Bangalore Diabetes Centre, No 426, 4th Cross, 2nd Block, Kalyan Nagar, Bangalore- 560 043
Bangalore
KARNATAKA 		 91-9845010610

drparamesh2@gmail.com 
Dr Hemant Premaji Thacker  Bhatia Hospital  Bhatia Hospital, G-1 Block, Tardeo Road, Mumbai- 400007
Mumbai
MAHARASHTRA 		 91-9820073882

drhpt@hotmail.com 
Dr Brij Mohan  Brij Medical Centre Pvt. Ltd.  Brij Medical Centre, 94-E, Near Panki Police Station, Kanpur-208020, Uttar Pradesh
Kanpur Nagar
UTTAR PRADESH 		 91-9415043742

drbrijmohan@bmchospital.in 
Dr Manoj Chawla  BSES Municipal General Hospital  , S. V Road, Opp.Railway Station, Andheri West, Mumbai- 400058
Mumbai
MAHARASHTRA 		 91-9820002333

drmanojchawla@yahoo.com 
Dr Dinesh Jain  Dayanand Medical College & Hospital  Dayanand Medical College & Hospital , Civil Lines, Ludhiana -141001, Punjab
Ludhiana
PUNJAB 		 9815532533

drjaindinesh@yahoo.co.in 
Dr Surendra Kumar Sharma  Diabetes Thyroid & Endocrine Centre  A-1, Madrampur, Ajmerpur Road, Near 4 No ESI Hospital, Ajmer Road, Sodala, Jaipur – 302006
Jaipur
RAJASTHAN 		 91-9829010233

sksharma.cr@gmail.com 
Dr S R Aravind  Diacon Hospital  Diacon Hospital,359-360, 19th Main, 1st Block, Rajajinagar, Bangalore-560010
Bangalore
KARNATAKA 		 91-9008998367

draravind@hotmail.com 
Dr J B Gupta  Eternal Hospital, Unit of Eternal Heart Care Centre and Research   Unit of Eternal Heart Care Centre and Research Institute Pvt. Ltd., 3 A, Jagatpura road,jawahar circle, Jaipur-302017
Jaipur
RAJASTHAN 		 9829414680

drjbgupta@gmail.com 
Dr Prajapati Vipul Kumar Buchubhai  GCS Medical College Hospital & Research Centre  Opp. DRM office, Near Chemundu bridge, Naroda road, Ahmedabad-380025
Ahmadabad
GUJARAT 		 91-7922201915

prajapativipul1983@gmail.com 
Dr Jayashri Prafulla Shembalkar  Getwell Hospital & Research Institute  20/1, Dr. Khare Marg, Dhantoli, Nagpur-440012
Nagpur
MAHARASHTRA 		 91-9665013901

pkshembalkar@hotmail.com 
Dr Sunil N Washimkar  Government Medical College & Super Speciality Hospital  Near Tukdoji square, Nagpur-440009
Nagpur
MAHARASHTRA 		 91-9823065380

sunil_wash@rediffmail.com 
Dr Hemant Gupta  Grant Government Medical College  Sir J J Group of Hospital, OPD -20, Main OPD Building, Byculla, Mumbai – 400008
Mumbai
MAHARASHTRA 		 91-9870456888

Drhemantgupta@hotmail.com 
Dr R Balamurugan  Kovai Diabetes Speciality Centre & Hospital  15, Vivekanand Road, Ram nagar, Coimbatore-641009
Coimbatore
TAMIL NADU 		 91-9842244881

rbmkdsc@gmail.com 
Dr Amol Dange  Lifepoint Multispecialty Hospital  145/1,Mumbai Bangalore Highway, Near Hotel Sayaji, Wakad, Pune - 411057
Pune
MAHARASHTRA 		 9823912040

amoldange298@gmail.com 
Dr Shashank R joshi  Lilavati Hospital and Research Centre  A-791, Bandra Reclamation, Bandra (W), Mumbai – 400050
Mumbai
MAHARASHTRA 		 91-9820189302

shashank.sr@gmail.com 
Dr Sandeep Kumar Gupta  M. V. Hospital and research centre  314/30, Mirza Mandi Chowk, lucknow-226003, Uttar Pradesh
Lucknow
UTTAR PRADESH 		 91-22-2258215

sandeepkumar.gupta@rediffmail.com 
Dr Prabhat Kumar Sharma  Maharaja Agrasen Super Speciality Hospital  Central Shine, Agrasen Aspetal Marg, Sector-7, Vidyadhar Nagar, Jaipur- 302039
Jaipur
RAJASTHAN 		 9983995050

swaps2503@yahoo.com 
Dr Sandeep Jain  Marudhar Hospital  Marudhar Hospital, A 93-99, Singh bhoomi, Khatipura, Jaipur - 302012
Jaipur
RAJASTHAN 		 9414069583

drsandeeprjain@yahoo.co.in 
Dr Chikkalingaiah Siddegowda  Medstar Speciality Hospital  No–641/17/1/3, Kodigehalli main road, Sahakar nagar, Bangalore-560092
Bangalore
KARNATAKA 		 9844004187

drchikkalingaiahmedstar@gmail.com 
Dr Piyush Desai  Nirmal Hospital  2/1423-8-6 Sangrampura, Ring road, Near Center point, Surat -395002
Surat
GUJARAT 		 91-9825144453

drdesaipiyush@gmail.com 
Dr Gaurav Hemendra Chhaya  Sanjivani Super Speciality Hospital Pvt. Ltd.  1 Uday Park Society, Near Sunrise Park, Vastrapur, Ahmedabad-380015
Ahmadabad
GUJARAT 		 91-9825324056

gaurav.chhaya2010@yahoo.com 
Dr Prakash Kurmi  Shivam Hospital  C-4, Satyanarayan Society, Gor No Kuvo, Jashoda nagar Cross Road, Mani nagar East, Ahmedabad-380008
Ahmadabad
GUJARAT 		 91-9825047692

dr_prakashkurmi@yahoo.co.in 
Dr Mahesh Fulwani  Shri Krishna Hrudayalaya and Critical Care Centre  Tikekar Road, Congress Nagar Square Dhantholi, Nagpur- 440012
Nagpur
MAHARASHTRA 		 91-9823078146

drmaheshfulwani@gmail.com 
Dr Sanjay Saran  SMS Medical College and attached Hospital  Dept. of Endocrinology, Room No 43 A fourth floor, Dhanvantri OPD Block, Jaipur-302004
Jaipur
RAJASTHAN 		 9760190799

drsanjaysaran@gmail.com 
Dr Keyur Bramhe  SSG Hospital  2nd Floor, Clinical Study Room, New Emergency Building, SSG Hospital, Medical College- Baroda, Anandpura, Vadodara- 390001
Vadodara
GUJARAT 		 91-9727729105

keyurbrahme@gmail.com 
Dr Pravin Dinkar Supe  Supe Heart & Diabetes Hospital & Research Centre  Opposite Adharashram, Gharpure Ghat, Ashok Stambh, Nasik 422002
Nashik
MAHARASHTRA 		 91-9405366165

pravinsupe@ymail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 28  
Name of Committee  Approval Status 
Ethics Committee-Apex Hospitals Pvt. Ltd.  Approved 
BSES Municipal General Hospital Ethics Committee  Approved 
Clinical Trial Ethics Committee-Bhatia Hospital  Approved 
Diacon Hospital Ethics Committee  Approved 
Drug Trial ethics Committee(DTEC)  Approved 
Eternal Heart Care Centre and Research Institute-Institutional Ethics Committee  Approved 
Ethics Committee Brij Medical Centre  Approved 
Ethics Committee- SMS Medical College and attached Hospitals  Approved 
Getwell Institutional Ethics Committee  Approved 
Human welfare Ethical Committee for Human Sciences and Research  Approved 
Institutional Ethics Committee for Human Research(IECHR), Medical college and SSG Hospital  Approved 
Institutional Ethics Committee for M. V. Hospital and research centre  Approved 
Institutional Ethics Committee Maharaja Agrasen Hospital  Approved 
Institutional Ethics Committee of Kovai Diabetes Speciality Centre & Hospital  Approved 
Institutional Ethics Committee, Government medical College Nagpur  Approved 
Institutional Ethics Committee, Life point hospital  Approved 
Institutional Ethics Committee- Arthur Asirvatham Hospital  Approved 
Institutional Ethics Committee- GCS Medical College Hospital & Research Centre  Approved 
Institutional Ethics Committee-GGMC and JJH  Approved 
Institutional Ethics Committee-Lilavati Hospital And Research Centre  Approved 
Marudhar Hospital Ethics Committee  Approved 
Medisys Clinisearch Ethical Review Board  Approved 
Medstar speciality hospital Ethics Committee  Approved 
Nirmal Hospital Ethics Committee  Approved 
Sanjivani Hospital Ethics Committee  Approved 
Shivam Ethics Committee(SEC)  Approved 
Supe Hospital Ethics Committee  Approved 
Virtuous institutional medical research ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  FDC of empagliflozin 25 mg and linagliptin 5 mg (or Matching Placebo) tablet, orally once daily   1. Dosage Form: Tablet. 2. Dosage Frequency: Once daily. 3. Dose: empagliflozin 25 mg and Linagliptin 5 mg. 4. Mode of Administration: Once daily in the morning with food preferably at similar time of the day. 
Intervention  FDC of remogliflozin etabonate 100 mg and vildagliptin 50 mg (or Matching Placebo) tablet, orally twice daily  1. Dosage Form: Tablet. 2. Dosage Frequency: Twice daily. 3. Dose: Remogliflozin etabonate 100 mg and Vildagliptin 50 mg. 4. Mode of Administration: Twice daily with food preferably at similar time of the day. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Male and female subjects ≥ 18 and ≤ 65 years of age, diagnosed with T2DM.
2. Subjects who have received stable dose of metformin ≥ 1500 mg/day as monotherapy for at least 10 weeks prior to screening and having inadequate glycemic control at screening defined as HbA1c levels of ≥ 8% to ≤ 11%.
 
 
ExclusionCriteria 
Details  1. History of Type 1 diabetes mellitus or secondary diabetes mellitus or diabetes insipidus
2. History of metabolic acidosis or diabetic ketoacidosis
3. FPG >270 mg/dL at screening.
If FPG is >270 mg/dL at screening, FPG will be repeated within 1 week. If repeat FPG is >270 mg/dL, subject will be excluded from the study.
4. Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2 using the Modification of Diet in Renal Disease (MDRD) equation or serum creatinine level of > 1.5 mg/dL for male subjects and > 1.4 mg/dL for female subjects, at screening.
5. Severe hepatic insufficiency and/or significant abnormal liver function defined as aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3X ULN or total serum bilirubin >2.0 mg/dL at screening
6. Congestive heart failure defined as New York Heart Association (NYHA) class III/IV, unstable or acute congestive heart failure.
7. Significant cardiovascular history defined as: myocardial infarction, unstable angina pectoris, transient ischemic attack, unstable or previously undiagnosed arrhythmia, cardiac surgery or revascularization (coronary angioplasty or bypass grafts), or cerebrovascular accident.
8. Intolerance, contraindication or potential allergy/hypersensitivity to any of the ingredients of study medication or any other SGLT2 inhibitors or DPP4 inhibitors
9. Subjects with symptomatic diarrhoea or any other medical condition which the investigators may judge to be a risk for dehydration and hypovolemia
10. Subjects with symptomatic urinary tract infection or mycotic genital infection at screening or history of a recent symptomatic infection within 4 weeks prior to screening
11. Subject with a positive result for hepatitis B surface antigen or hepatitis C antibody at screening.
12. Subject is known to be seropositive for human immunodeficiency virus (HIV).
 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Centralized 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Mean change in HbA1c levels from baseline to end of treatment  16 Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Mean change from baseline in HbA1c levels at week 12  12 Weeks 
Mean change from baseline in fasting plasma glucose (FPG) levels at end of treatment  16 weeks 
Mean change from baseline in post-prandial plasma glucose (PPG) at end of treatment  16 Weeks 
Mean change from baseline in body weight at end of treatment  16 Weeks 
Proportion of subjects achieving a therapeutic glycaemic response, defined as HbA1c 7%, end of treatment  16 Weeks 
 
Target Sample Size   Total Sample Size="400"
Sample Size from India="400" 
Final Enrollment numbers achieved (Total)= "400"
Final Enrollment numbers achieved (India)="400" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   31/01/2020 
Date of Study Completion (India) 23/07/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This study is a randomized, double blind, double dummy, active controlled, parallel group, multi-centre trial comparing the safety and efficacy of FDC of remogliflozin etabonate (100 mg) and vildagliptin (50 mg) given twice daily with that of FDC of empagliflozin (25 mg) and linagliptin (5 mg) once daily in 400 patients who have inadequately controlled type 2 diabetes mellitus on stable dose of metformin for at least 10 weeks. The subject’s will continue to receive metformin at stable doses of ≥ 1500 mg per day, throughout the study period in an open label manner. The study consist of screening period of up to 3 weeks and includes a 2 week run in period, 16 weeks study treatment and a safety follow��’up period of 2 weeks post last dose of the study drug. The primary outcome measures will be mean change from baseline in HbA1c at the end of treatment. Any adverse event (AE), either clinical/laboratory, will be recorded and assessed for severity, seriousness and causality. 
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