To Compare effects of Trelagliptin with Teneligliptin in changes arterial hardening in people with Type 2 Diabetes Mellitus

Effect of Trelagliptin on vascular stiffness in comparison to Teneligliptin in type 2 diabetes mellitus: a pilot randomized controlled trial - VASTT-D

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/08/092604

Enrollment

Registered

2025-08-07

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: Trelagliptin: Patients will receive Tab Trelagliptin 100 mg once weekly Control Intervention1: Teneligliptin: Patients will receive Tab Teneligliptin 20 mg once daily

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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 24Timepoint: 6 months	—

Secondary

Measure	Time frame
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 effectsTimepoint: 6 months	—

Countries

India

Contacts

Public ContactDr Arindam Naskar

School of Tropical Medicine

indrani.bbs@gmail.com7044007741

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026