| CTRI Number |
CTRI/2021/10/037574 [Registered on: 26/10/2021] Trial Registered Prospectively |
| Last Modified On: |
28/06/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of utility of Viladagliptin 50 mg tablet twice daily and metformin combination therapy with Vildagliptin 100 mg sustained release tablet once daily and metformin combination therapy in Indian patients with type 2 diabetes mellitus: A randomized open label phase IV clinical trial |
|
Scientific Title of Study
|
Comparison of efficacy and safety of Viladagliptin 50 mg tablet twice daily and metformin combination therapy with Vildagliptin 100 mg sustained release tablet once daily and metformin combination therapy in Indian patients with type 2 diabetes mellitus: A randomized open label phase IV clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rudra Paul |
| Designation |
Demonstrator |
| Affiliation |
NRS Medical College |
| Address |
Dept of Pharmacology
NRS Medical College
Kolkata-700014
Kolkata
WEST BENGAL
700014
India |
| Phone |
9433153785 |
| Fax |
|
| Email |
academicrudra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arijit Ghosh |
| Designation |
Associate Professor |
| Affiliation |
NRS Medical College |
| Address |
Dept of Pharmacology
NRS Medical College
Kolkata-700014
Kolkata
WEST BENGAL
700014
India |
| Phone |
9874727137 |
| Fax |
|
| Email |
drarijitghosh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arijit Ghosh |
| Designation |
Associate Professor |
| Affiliation |
NRS Medical College |
| Address |
Dept of Pharmacology
NRS Medical College
Kolkata-700014
Kolkata
WEST BENGAL
700014
India |
| Phone |
9874727137 |
| Fax |
|
| Email |
drarijitghosh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Study Medication, Laboratory investigations |
|
|
Primary Sponsor
|
| Name |
Dr Rudra Paul |
| Address |
Dept of Pharmacology
NRS Medical College
Kolkata
|
| Type of Sponsor |
Other [Self Sponcered] |
|
|
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 Rudra Paul |
Dept of Endocrinology |
Dept of Endocrinology
NRS Medical College
Kolkata
WEST BENGAL |
9433153785
academicrudra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, NRS Medical College |
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 |
Metformin 1000 mg per day and Vildagliptin 100 mg SR |
Metformin 1000 mg per day and Vildagliptin 100 mg SR once daily for 12 weeks |
| Comparator Agent |
Metformin 1000 mg per day and Vildagliptin 50 mg twice daily |
Metformin 1000 mg per day and Vildagliptin 50 mg twice daily for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 Age > 18 yrs
2 Newly Diagnosed cases with type 2 diabetes mellitus
3 HbA1C ≥ 6.5 & ≤ 8
|
|
| ExclusionCriteria |
| Details |
ï¶ Female patients who are pregnant or lactating
1 FPG > 250mg/dl, PPPG > 350mg/dl
2 Co-morbid cardiovascular, hepatic renal and psychatric complications
3 Co-administration of drugs that are likely to interact with vildagliptin or metformin
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in HbA1C At week 12 visit |
Change in HbA1C At week 12 visit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in FPG, PPPG at week 4, 8 and 12 visits |
At the intervals of weeks 4, 8 and 12 |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/11/2021 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Present study is aimed to compare efficacy and safety of Metformin and Vildagliptin 100 mg SR combination therapy with Metformin and Vildagliptin 50 mg twice daily combination therapy |