| CTRI Number |
CTRI/2025/04/085124 [Registered on: 21/04/2025] Trial Registered Prospectively |
| Last Modified On: |
21/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To evaluate the demographic characteristics, clinical parameters, and treatment pattern of FDC(Dapagliflozin 10 mg, Metformin 500mg and Vildagliptin 100mg SR) versus FDC(Dapagliflozin,Metformin)
and FDC (Dapagliflozin,Vildagliptin SR). |
|
Scientific Title of Study
|
A real-world prospective, multicenter, observational comparative study for Clinical Evaluation of Triple Combination Therapy (FDC Dapagliflozin, Metformin and Vildagliptin SR) versus Dual Drug Combinations (FDC Dapagliflozin plus Metformin and FDC Dapagliflozin plus Vildagliptin SR) and assess their effectiveness and safety in Type 2 Diabetes Management. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| JALR/USV/RWS/2024 v1.0, 26 Jul 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abhijit Pednekar |
| Designation |
Vice President - Medical |
| Affiliation |
USV Private Limited |
| Address |
Room No 1 Scitenfic division B.S.D. Marg, Arvind Vithal Gandhi, Chowk,
Govandi East
Mumbai (Suburban)
MAHARASHTRA
400088
India |
| Phone |
9920489007 |
| Fax |
|
| Email |
abhijit.pednekar@usv.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sona Warrier |
| Designation |
Medical Advisor |
| Affiliation |
USV Private Limited |
| Address |
Room No 1 Scitenfic division B.S.D. Marg, Arvind Vithal Gandhi, Chowk,
Govandi East
Mumbai (Suburban)
MAHARASHTRA
400088
India |
| Phone |
7738104068 |
| Fax |
|
| Email |
sona.b.warrier@usv.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sona Warrier |
| Designation |
Medical Advisor |
| Affiliation |
USV Private Limited |
| Address |
Room No 1 Scitenfic division B.S.D. Marg, Arvind Vithal Gandhi, Chowk,
Govandi East
Mumbai (Suburban)
MAHARASHTRA
400088
India |
| Phone |
7738104068 |
| Fax |
|
| Email |
sona.b.warrier@usv.in |
|
|
Source of Monetary or Material Support
|
| USV Private Limited
B.S.D. Marg, Arvind Vithal Gandhi, Chowk,
Govandi East, Mumbai,
Maharashtra 400088
|
|
|
Primary Sponsor
|
| Name |
USV Private Limited |
| Address |
USV Private Limited
B.S.D. Marg, Arvind Vithal Gandhi, Chowk,
Govandi East, Mumbai,
Maharashtra 400088 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| USV Private Limited |
USV Private Limited
B.S.D. Marg, Arvind Vithal Gandhi, Chowk,
Govandi East, Mumbai,
Maharashtra 400088 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr G Vijayakumar |
Diabetes Medicare Centre |
1st floor Room no 2 ,New No 8, Old No 19/3, Ram Flats, No 3, Raja Street, T Nagar
Chennai
TAMIL NADU |
9841044301
diabetesgoodlife@yahoo.co.in |
| Dr Kirti Samudra |
Dr. Kirthi Samudras Diabetes and Eye Care Clinic |
Room no 1 13, Vijay Marg, Opp.Shreeyash Hospital, Sector 19, New Panvel East, Panvel, navi mumbai
Mumbai
MAHARASHTRA |
9867579565
dr.kirtisamudra@gmail.com |
| Dr Lily Rodrigues |
Surakshaka Multispeciality Hospital |
1st floor Room no 1 KPHB main Road, Kukatpally
Hyderabad
TELANGANA |
9885250500
drrlily@gmail.com |
| Dr Mukulesh Gupta |
Udyan Health Care Pvt Ltd |
1st floor room No 1, 730, Near Bangla Bazar, Eldeco Udyan1
Lucknow
UTTAR PRADESH |
9336046146
drmukulesh@yahoo.com |
| Dr Jayant Kumar Panda |
Wellbeing hospital |
Room No 1 Bijupatnaik Square, Tulsipur
Cuttack
ORISSA |
9437028282
drjayantpanda@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Institutional EC Human EC |
Approved |
| Institutional Ethics Committee |
Submittted/Under Review |
| RIPON Independent Ethics Committee |
Approved |
| Sukham Ethics Committee |
Approved |
| Surakshaka Institutional Ethics Committee |
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 Dapagliflozin 10 mg + Metformin 500 mg +
Vildagliptin 100 mg (SR) |
1 tablet in a day for 6 months |
| Comparator Agent |
FDC of Dapagliflozin 10mg + Metformin 500mg |
1 tablet in a day for 6 months |
| Comparator Agent |
FDC of Dapagliflozin 10mg + Vildagliptin 100mg(SR) |
1 tablet in a day for 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Subject willing to provide written informed consent.
2.Subject having documented history of diabetes mellitus greater than or equal to 12 months
3.Subjects receiving 2 or more Oral anti-hyperglycaemic medications (OAMs) at stable doses for 12 weeks prior to screening, with metformin greater than or equal 500 mg per day or dapagliflozin ( greater than or equal 5 mg/day) or vildagliptin (greater than or equal 100 mg/day)
4.Glycated haemoglobin (HbA1c) between 8.0% and 10.5%.
5.Subjects with body mass index (BMI) Greater than 18 kg/m² and less than 40 kg/m² at screening
6.Ability and willingness to administer study medication as prescribed by the study investigator
7.As determined by the investigator, the subject should be capable and willing to do the following:
a.Perform self-monitored blood glucose (SMBG) at least once weekly and at the occurrence of hypoglycaemia symptoms
b.Complete subject diaries as instructed
c.Be receptive to diabetes education |
|
| ExclusionCriteria |
| Details |
1.Suspected hypersensitivity to either of the study medications or any of the ingredients of the formulation
2.Surgical or medical condition that, in the judgment of the Investigator or Sponsor, could interfere with the test product to be used
3.Female subject who is pregnant or lactating
4.Subjects with a diagnosis of type 1 diabetes, gestational diabetes mellitus
5.Subject with abnormal eGFR (less than 30 mL per min or 1.73 m2).
6.Subjects with any one of the following comorbid conditions – physical or mental retardation, or malignancy
7.Participants with a recent history (within the previous 6 months) or current history of drug abuse or alcohol abuse
8.Not eligible to participate in this trial based on investigator opinion
9.Trial related conditions
a.Concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent
b.Suspected inability or unwillingness to comply with the study procedures |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| changes in demographic characteristics, clinical parameters and treatment pattern |
From baseline to end of study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| evaluates the safety of patients |
Safety will be evaluated at various time points of the study at 3 months & 6 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
N/A |
|
Date of First Enrollment (India)
|
05/05/2025 |
| 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="0"
Months="8"
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
|
This is a real-world prospective, multicenter, observational study for Clinical Evaluation of Triple Combination Therapy (FDC Dapagliflozin, Metformin and Vildagliptin SR) versus Dual Drug Combinations (FDC Dapagliflozin, Metformin and FDC Dapagliflozin, Vildagliptin SR) and a Comparative Study on Effectiveness and Safety in Type 2 Diabetes Management. Data related to demographic characteristics, duration of disease, co-morbidities, concomitant medications, lab results and dosage pattern will be collected from medical records authenticated by physicians/cardiologists during routine care. |