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CTRI Number  CTRI/2025/08/092604 [Registered on: 07/08/2025] Trial Registered Prospectively
Last Modified On: 29/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To Compare effects of Trelagliptin with Teneligliptin in changes arterial hardening in people with Type 2 Diabetes Mellitus  
Scientific Title of Study
Modification(s)  		 Effect of Trelagliptin on vascular stiffness in comparison to Teneligliptin in type 2 diabetes mellitus: a pilot randomized controlled trial 
Trial Acronym  VASTT-D 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Arindam Naskar 
Designation  Assistant Professor 
Affiliation  School of Tropical Medicine 
Address  Room No 16, School of Tropical Medicine, 108 CR avenue

Kolkata
WEST BENGAL
700073
India 
Phone  7044007741  
Fax    
Email  indrani.bbs@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Arindam Naskar 
Designation  Assistant Professor 
Affiliation  School of Tropical Medicine 
Address  Room No 16, School of Tropical Medicine, 108 CR avenue

Kolkata
WEST BENGAL
700073
India 
Phone  7044007741  
Fax    
Email  indrani.bbs@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Arindam Naskar 
Designation  Assistant Professor 
Affiliation  School of Tropical Medicine 
Address  Room No 16, School of Tropical Medicine, 108 CR avenue

Kolkata
WEST BENGAL
700073
India 
Phone  7044007741  
Fax    
Email  indrani.bbs@gmail.com  
 
Source of Monetary or Material Support  
School of Tropical Medicine, 108 CR Avenue, Kolkata-700073, India 
 
Primary Sponsor  
Name  ARINDAM NASKAR 
Address  Room No 16, School of Tropical Medicine, 108 CR Avenue, Kolkata 700073 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Arindam Naskar  School Of Tropical Medicine  Room No 16, Department of Endocrinology, Nutrition and Metabolic diseases, 108 CR Avenue, Kolkata 700073
Kolkata
WEST BENGAL 		 7044007741

indrani.bbs@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Clinical Research Ethics Committee (CREC-STM)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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  Teneligliptin  Patients will receive Tab Teneligliptin 20 mg once daily 
Intervention  Trelagliptin   Patients will receive Tab Trelagliptin 100 mg once weekly  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Adult subjects ( more than 40 yrs to less than65 of age),of any gender
Established diagnosis of type 2 diabetes mellitus
Inadequate glycaemic control with existing glycated haemoglobin (HbA1c) value ranging between 7.0-9.0
Willing to providing written informed consent 
 
ExclusionCriteria 
Details  History of serious hypersensitivity reaction to any DPP-4 in past
Pregnancy or breastfeeding
Patients having estimated GFR less than 50 ml/min/1.73m2
Patients having established cardiac rhythm disorder like atrial
fibrillation or atrial flutter, implanted permanent pacemaker, sick sinus syndrome or atrio-ventricular block of more than second degree
Patients suffered from Acute Myocardial Infarction, Unstable angina , Cerebrovascular accident within last 6 months
Patients known Heart failure (Stage III or IV)
Severe liver dysfunction(Child Pugh C)
Baseline AST, ALT more than 3 times of upper limit
History of chronic pancreatitis
Patients with Bullous Pemphigoid
Patients with BMI more than 40
Patients taking any other concomitant medication which is known to effect arterial stiffness (GLP1 agonist/SGLT2 inhibitors)
Tobacco abusers, Alcoholic and any kind of substance abusers
Patients with malignancy and/or on chemotherapy
Patients with infectious disease like HIV, HepB, HepC 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the effect of Trelagliptin vs Teneligliptin on
arterial stiffness as an add-on therapy to pre- existing oral antidiabetic
drugs (as per standard of care) in patients of T2DM
with impaired glycaemic status (HbA1c more than 7 but less than9) from baseline to week 24 		 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
To compare changes from baseline to week 24 in
1. HbA1C,FBS,PPBS, bodyweight
2. Proportion of patients achieving HbA1C less than 7%
3. To evaluate any adverse effects 		 6 months 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
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   Phase 3 
Date of First Enrollment (India)   22/08/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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   DPP4 Inhibitors have shown mixed results in improving vascular outcomes. Trelagliptin, is a newer DPP4 inhibitor, recently been launched in India. Till now , a single pilot study has been done on Trelagliptin effect on Flow mediated dilatation (FMD)  and it failed to show any significant changes on FMD. However, its effect on Pulse wave Velocity (PWV), which is a marker of vascular stiffness, is still lacking in clinical trial. This pilot trial aims to investigate whether Trelagliptin has any effect on PWV as well as vascular stiffness in Type 2 Diabetes mellitus patients. 
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