| CTRI Number |
CTRI/2022/05/042581 [Registered on: 17/05/2022] Trial Registered Prospectively |
| Last Modified On: |
18/09/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To assess safety and efficacy of Remogliflozin-Metformin-Vildagliptin combination in treatment of patients with Diabetes in India |
|
Scientific Title of Study
|
A Phase IV, prospective, single arm, baseline controlled, multi-centric study for assessment of safety and efficacy of Fixed dose combination (FDC) of Remogliflozin Etabonate, Metformin and Vildagliptin (RMV) in management of Type 2 Diabetes Mellitus (T2DM) patients |
| Trial Acronym |
TRIAD-RMV |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| GPL/CT/2021/011/IV Version 2.0 dated 10-Jan-2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sachin Suryawanshi |
| Designation |
General Manager- Global Medical Affairs (IF) |
| Affiliation |
Glenmark Pharmaceuticals Ltd. |
| Address |
Glenmark Corporate Enclave, BD Sawant Marg, Andheri East, Mumbai 400099
Mumbai (Suburban)
MAHARASHTRA
400099
India |
| Phone |
|
| Fax |
|
| Email |
Sachin.Suryawanshi@glenmarkpharma.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sachin Suryawanshi |
| Designation |
General Manager- Global Medical Affairs (IF) |
| Affiliation |
Glenmark Pharmaceuticals Ltd. |
| Address |
Glenmark Corporate Enclave, BD Sawant Marg, Andheri East, Mumbai 400099
MAHARASHTRA
400099
India |
| Phone |
|
| Fax |
|
| Email |
Sachin.Suryawanshi@glenmarkpharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Rujuta Gadkari |
| Designation |
Manager- Global Medical Affairs (IF) |
| Affiliation |
Glenmark Pharmaceuticals Ltd. |
| Address |
Glenmark Corporate Enclave, BD Sawant Marg, Andheri East, Mumbai 400099
Mumbai (Suburban)
MAHARASHTRA
400099
India |
| Phone |
|
| Fax |
|
| Email |
rujuta.gadkari@glenmarkpharma.com |
|
|
Source of Monetary or Material Support
|
| Glenmark Pharmaceuticals Ltd.
Glenmark House, B D Sawant Marg, Andheri East, Mumbai - 400099 |
|
|
Primary Sponsor
|
| Name |
Glenmark Pharmaceuticals Ltd |
| Address |
Glenmark House, B D Sawant Marg, Andheri East, Mumbai - 400099 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Divendu Bhushan |
All India Institute of Medical Sciences |
Dept. of General Medicine, PHULWARISHARIF, Patna Bihar- 801507
Patna
BIHAR |
9661216010
drdivendubhushan@aiimspatna.org |
| Dr K Sunil Naik |
Government General Hospital |
Balaga Srikakulam Andhra
Pradesh - 532001 India
Srikakulam
ANDHRA PRADESH |
8942279033
drsunilnaikggh@gmail.com |
| Dr Hemant Gupta |
Grant Govt Medical College |
OPD No 20, Department of Internal Medicine, old OPD building, Grant Govt Medical College and Sir J.J Group of Hospital Byculla, Mumbai-400008
Mumbai
MAHARASHTRA |
9870456888
drhemantgupta@hotmail.com |
| Dr AMIT SURESH BHATE |
Jeevan Rekha Hospital |
Dr. B R Ambedkar Road, Belagavi, Karnataka- 590010
Belgaum
KARNATAKA |
9667177125
dr.amitsureshbhate@gmail.com |
| Dr Sandeep Garg |
Maulana Azad Medical College |
Room No.120, Department of Medicine BL Taneja Block, Maulana Azad Medical College and Associated Hospitals, New Delhi 11002
New Delhi
DELHI |
9958311466
drsandeepgargmamc@gmail.com |
| Dr Pravin Soni |
PCMCs PGI YCM Hospital |
Dept. of General Medicine, 2nd Floor General Medicine Dept., PCMCs PGI YCM Hospital, Sant Tukaram Nagar, Pimpri, Pune-411018
Pune
MAHARASHTRA |
9822027511
drpravinsoni18@gmail.com |
| Dr JS Kushwaha |
Prakhar Hospital Pvt Ltd |
8/219 Arya Nagar,
Kanpur, Uttar Pradesh-208002
Kanpur Nagar
UTTAR PRADESH |
7905113329
dr.jskushwahacr@gmail.com |
| Dr Prabhat Kumar Agrawal |
S.N. Medical College |
Central Library, Moti Katra, Mantola Agra, Uttar pradesh- 282003
Agra
UTTAR PRADESH |
9319250485
ppagrawal120@gmail.com |
| Dr Shailesh Rajaram Adwani |
Sterling Multispeciality Hospital |
P.D.E.A’s(Pune District Education Association) Ayurved Rugnalay & Sterling Multispeciality Hospital,
Sec no 27, Near Bhel Chowk, Nigdi Pradhikaran, Pune 411 044, MH, India.
Pune
MAHARASHTRA |
9423583838
sradwani@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| Ethics Committee of The Prakhar Hospital Kanpur |
Approved |
| Institute Ethics Committee All India Institute of Medical Sciences Patna |
Approved |
| Institutional Ethics Committee Govt. Medical College Govt. General Hospital Balaga Srikakulam |
Approved |
| Institutional Ethics Committee Jeevan Rekha Hospital |
Approved |
| Institutional Ethics Committee Sterling Multispeciality Hospital |
Approved |
| Institutional Ethics Committee, Grant Govt Medical College |
Approved |
| Institutional Ethics Committee, S N Medical College, Agra |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
| Intervention |
FDC of Remogliflozin - Vildagliptin - Metformin |
Twice daily orally for 24 weeks |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult Indian (Age ≥18 years, ≤ 65 years) of either gender, diagnosed with T2DM for more than 6 months
2. On ongoing dual drug regimen of stable dose of Metformin+DPP4i or Metformin+SGLT2i since last 12 weeks before screening
3. With Daily Metformin Dose on 1000mg or 2000mg
4. Uncontrolled glycaemia with HbA1c ≥ 8% at time of screening
5. Patient willing to provide signed and dated, written informed consent prior to any study specific procedures |
|
| ExclusionCriteria |
| Details |
1. H/o hypersensitivity or contraindication to the contents of the IP, (Remogliflozin Etabonate, Vildagliptin and Metformin)
2. Patients of Type 1 diabetes.
3. Patient suffering from any moderate to severe hepatic, cardiac, neurologic or neoplastic disorder
4. Patients with eGFR <60 mL/min/1.73 m2 at time of initiation of Remogliflozin Etabonate (RE) therapy (eGFR of <45 L/min/1.73m2 in patients on Metformin+RE)
5. History of pancreatitis or pancreatic surgery
6. Patients with a history of any malignancy
7. History of diabetic ketoacidosis
8. Any acute/chronic systemic infections
9. Recurrent urogenital infections
10. Patients at risk for volume depletion as judged by the investigator
11. Active participation in another clinical study with IP and/or investigational device
12. For women only – currently pregnant (confirmed with positive pregnancy test) or breast-feeding.
13. Any condition which, in the judgment of the Investigator, may render the patient unable to complete the study or which may pose a significant risk to the patient or patient suspected or with confirmed poor protocol or medication compliance. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of related TEAEs of special interest as assessed by physician |
Up to Week 24 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Mean change from baseline in HbA1c levels at Week 24
2. Mean change from baseline in HbA1c levels at Week 12
3. Mean change from baseline in FPG, PPG levels, Body weight, Waist circumference, Blood pressure at Week 12 and 24.
4. Proportion of patients achieving target glycemic control of HbA1c ≤7% at Week 12 and 24
5. Proportion of patients requiring rescue medications by 12 and 24 weeks of treatment.
6. Mean change from baseline in TG, TC, LDL-C and HDL-C at Week 24
7. Incidence of TEAEs, TESAEs, TEAEs leading to dose modification/discontinuation of treatment [Time frame: up to Week 24]
8. Incidence of solicited and unsolicited adverse events (Clinical signs, symptoms, laboratory parameters) during the study period of 24 weeks |
Up to Week 24 |
|
|
Target Sample Size
|
Total Sample Size="215"
Sample Size from India="215"
Final Enrollment numbers achieved (Total)= "215"
Final Enrollment numbers achieved (India)="215" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
20/05/2022 |
| Date of Study Completion (India) |
28/01/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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)?
Response - NO
|
|
Brief Summary
|
This study is being conducted to assess safety and efficacy of Remogliflozin+Metformin+Vildagliptin FDC on patients with T2DM. This study is a Prospective, single arm, baseline controlled, multi-centric study. It will be conducted on 215 patients across approx. 9 centres in India. All enrolled patients will be followed up for a period of 24 weeks. AEs, TEAEs will be evaluated during the entire study duration. |