Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Intervention arm-Bempedoic Acid 180 mg add on to Atorvastatin 20 mg
: Intervention: Bempedoic acid 180mg daily as add on therapy to Atorvastatin 20mg daily Control arm: Atorvastatin 40m
Sponsors
ARINDAM NASKAR
Eligibility
Inclusion criteria
Inclusion criteria: Established diagnosis of type 2 diabetes mellitus (T2DM) [As per American Diabetes Association criteria for diagnosis of T2DM] Serum LDL more than 70 mg/dl with Atorvastatin (20mg daily) therapy for at least 6 months Willing to providing written informed consent
Exclusion criteria
Exclusion criteria: Patients having estimated GFR less than 30 ml/min/1.73m2 by CKD-EPI criteria Patients known Heart failure (Stage III or IV) Severe liver dysfunction (Child Pugh C) Baseline AST and ALT more than 3 times of upper limit Hemoglobin less than 8 gm/dl Tobacco abusers and any kind of substance abusers Patients with malignancy and/or on chemotherapy Patients with infectious disease like HIV Hepatitis B and Hepatitis C Hyperuricemia (Male more than 7 mg/dl, female more than 6 mg/dl) History of Tendon rupture
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effect of Bempedoic acid vs standard of care on arterial stiffness in patients of T2DM with LDL more than 70 mg/dl from baseline to week 24.Timepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare any changes from baseline to week 24 in Lipid Profile BMI eGFR Urinary albumin creatinine ratio ALT and ASTTimepoint: 6 months | — |
Countries
India
Contacts
Public ContactDr Arindam Naskar
School of Tropical Medicine
Outcome results
None listed