| CTRI Number |
CTRI/2026/01/100048 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
31/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
How Safe and Effective Are Vildagliptin and Remogliflozin with Metformin in People with Type 2 Diabetes |
|
Scientific Title of Study
|
A study of the safety and effectiveness of Vildagliptin and Remogliflozin when added to Metformin in Type 2 Diabetes patients in Kanpur |
| Trial Acronym |
T2DM |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nilam Nigam |
| Designation |
Professor |
| Affiliation |
Rama Medical College Hospital and Research Centre, Kanpur |
| Address |
Department of Pharmacology and Therapeutics, Rama Medical College, Mandhana Kanpur,Uttar Pradesh. Rama Medical College Hospital and Research Centre, Kanpur Kanpur Nagar UTTAR PRADESH 209217 India |
| Phone |
9140190479 |
| Fax |
|
| Email |
drnilamnigam@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Nilam Nigam |
| Designation |
Professor |
| Affiliation |
Rama Medical College Hospital and Research Centre, Kanpur |
| Address |
Department of Pharmacology and Therapeutics, Rama Medical College, Mandhana Kanpur,Uttar Pradesh. Rama Medical College Hospital and Research Centre, Kanpur
Kanpur Nagar UTTAR PRADESH 209217 India |
| Phone |
9140190479 |
| Fax |
|
| Email |
drnilamnigam@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Ravi Kumar |
| Designation |
Junior Resident |
| Affiliation |
Rama Medical College Hospital and Research Centre, Kanpur |
| Address |
Department of Pharmacology and Therapeutic, 3rd floor, room number 03154, Rama Medical College, Mandhana ,Kanpur , Uttar Pradesh, India Department of Pharmacology and Therapeutic, 3rd floor, room number 03154, Rama Medical College, Mandhana ,Kanpur , Uttar Pradesh Kanpur Nagar UTTAR PRADESH 209217 India |
| Phone |
08303434055 |
| Fax |
|
| Email |
ravikumar17jul@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pharmacology and Department of Medicine Infrastructural support by Rama
medical college hospital and research centre, madhana Kanpur,uttar pradesh, India-209217 |
|
|
Primary Sponsor
|
| Name |
Rama Medical College Hospital and research centre |
| Address |
Department of Pharmacology and Therapeutic, 3rd floor, room number 03154, Rama Medical College, Mandhana ,Kanpur , Uttar Pradesh, India -209217 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ravi Kumar |
Rama medical college and Hospital |
Department of pharmacology room number
03154 and Department of medicine
Room Number 1, Rama medical College Hospital
and Research Centre, Mandhana Kanpur, Uttar
Pradesh, India -209217 Kanpur Nagar UTTAR PRADESH |
08303434055
ravikumar17jul@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Rama medical College Hospital and Research Centre,Kanpur |
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 |
Remogliflozin |
TABLET REMOGLIFLOZIN 100 MG TWICE A DAY PERORAL FOR 3 MONTHS |
| Comparator Agent |
Vildagliptin |
TABLET VILDAGLIPTIN 50 MG TWICE A DAY PERORAL FOR 3 MONTHS |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Age between 35 and 70 years all sexes
2.Diagnosed with T2DM with HbA1c more than 6.5 percentage
3.Currently taking a stable dose of metformin (more than equal to 1500 mg per day or maximum tolerated dose) for
more than equal to months.
|
|
| ExclusionCriteria |
| Details |
Use of other anti-diabetic medications besides metformin
Hepatic dysfunction (ALT and AST more than equal to 2.5 UNL or Bilirubin more than 2x UNL)
Renal dysfunction (eGFR less than 45 ml per min per 1.73 m²)
Active genitourinary tract infections and lower limb cellulitis or ulcers
Known case of osteoporosis
Known allergy to study medications
Pregnant or nursing patients
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Detailed medical history
Systemic examination
blood sugar profile
others biochemical examination
|
Baseline Visit (Day 0) and Follow-up Visit (Day 90): |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="80" 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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
20/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Background and Rationale Type 2 Diabetes
Mellitus is a progressive chronic disease requiring treatment
intensification over time to maintain
glycemic control While Metformin is the established Firstline therapy its
efficacy diminishes as insulin resistance and beta cell dysfunction worsen This necessitates add on therapies The American Diabetes Association recommends several classes of drugs, including Dipeptidyl Peptidase 4 inhibitors and Sodium-Glucose Cotransporter2 inhibitors, for second line treatment.
Vildagliptin a
DPP4 inhibitor is a well established weight neutral agent with a good safety
profile Remogliflozin etabonate is a newer SGLT2 inhibitor that not only
improves glycemic control but also offers the additional benefits of weight
loss and blood pressure reduction Its availability at a lower cost
in India makes it a potentially attractive and cost-effective option for a large
patient population
While both drug classes
are effective there
is a lack of direct head to head comparative data between the established DPP4 inhibitor
Vildagliptin and the newer more affordable SGLT2 inhibitor Remogliflozin especially within the Indian population This study aims to address
this gap by directly comparing their efficacy and safety as add on therapy in patients with T2DM inadequately
controlled with metformin
Objectives Primary Objective To compare
the efficacy of vildagliptin and remogliflozin
as add on therapy to metformin
in patients with type 2 diabetes mellitus in terms of their effect on HbA1c
levels
Secondary Objectives To compare the safety of vildagliptin and remogliflozin as add on therapy
to metformin To compare
the effect of vildagliptin and remogliflozin on
lipid profile and body weight
|