Health Condition 1: E789- Disorder of lipoprotein metabolism, unspecified
Conditions
Interventions
Intervention1: Test Group 1, Bempedoicacid 180mg plus Ezetimibe 10mg as a fixed dose combination.
: Bempedoicacid 180mg plus Ezetimibe 10mg as a fixed dose combination over baseline statin therapy, gi
Sponsors
SRM College of Pharmacy
Eligibility
Inclusion criteria
Inclusion criteria: 1. Men and women above 18 years of age are include. 2. Patients diagnosed with Type 2 Diabetes Mellitus and dyslipidemia. 3. Participants receiving baseline statin therapy should have fasting LDL-C level of 100mg/dL or higher at first screening visit. 4. Patients receiving antihyperglycemic medication before randomization and HbA1c between 6.5% to 10% at randomization
Exclusion criteria
Exclusion criteria: 1. Patients with recent history of clinically significant cardiovascular disease, including uncontrolled hypertension, planned revascularization procedure, NYHA class IV heart failure. 2. Myocardial infarction, severe or unstable angina, coronary angioplasty, coronary artery bypass graft surgery, stroke, transient ischaemic attack within 3 months of screening are excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the insulin sensitivity using HOMA IR index score and improvement of beta cell function C peptide.Timepoint: After 90 days | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the reduction in HbA1c levels and reducing LDL-C and total cholesterol levels in diabetic dyslipidemic patients.Timepoint: After 90 days | — |
Countries
India
Contacts
Public ContactKarthick Perumal
SRM Institute
Outcome results
None listed