Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Tab Trelagliptin 100 mg once weekly: One group will receive Tab Trelagliptin 100 mg once weekly and other group will receive Tab Teneligliptin 20 mg daily to compare effects of both dru
Sponsors
DR ARINDAM NASKAR
Eligibility
Inclusion criteria
Inclusion criteria: Established Type 2 DM according to ADA diagnostic criteria HbA1c between 7.0% and 10.0% with existing oral antidiabetic drugs (OADs) and Insulin Willing and able to provide written informed consent.
Exclusion criteria
Exclusion criteria: History of serious hypersensitivity reaction to any DPP-4 inhibitor. Pregnant or breastfeeding women. Renal impairment with estimated GFR less than 50 mL/min/1.73 m . Cardiac rhythm disorders such as atrial fibrillation atrial flutter implanted permanent pacemaker sick sinus syndrome or atrioventricular block of second degree or higher. Recent cardiovascular or cerebrovascular events-Acute Myocardial Infarction Unstable Angina or Cerebrovascular Accident within the last 6 months. Heart failure- NYHA Class III or IV. Severe hepatic dysfunction- Child-Pugh Class C or baseline AST/ALT more than 3 times upper limit of normal. History of chronic pancreatitis. History of Bullous Pemphigoid. Body Mass Index (BMI) more than 40 kg/m . Concomitant medications affecting cardiac autonomic function (e.g. SGLT2 inhibitors GLP-1 receptor agonists). Tobacco alcohol or substance abuse. Known malignancy or ongoing chemotherapy. Active infectious diseases such as HIV Hepatitis B or Hepatitis C.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effect of Trelagliptin vs Teneligliptin on cardiac autonomic function as an add-on to standard oral antidiabetic therapy in patients with T2DM (HbA1c more than 7% to less than 9 %) from baseline to 24 weeks. Timepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess change in HbA1c, FBS, PPBS, and BMI from baseline to week 24. To assess change in insulin resistance markers (HOMA-IR, TyG index, TG/HDL, METS-IR) from baseline to week 24. To evaluate any adverse effects during the study period. Timepoint: 6 months | — |
Countries
India
Contacts
Public ContactDR ARINDAM NASKAR
Outcome results
None listed