Dual vs Triple Lipid-Lowering Therapy in Type 2 Diabetes Mellitus Patients With Elevated LDL Cholesterol

Summary

This Open-label, randomized clinical trial evaluates the comparative efficacy and safety of dual versus triple lipid-lowering therapy using rosuvastatin, ezetimibe, and bempedoic acid in patients with type 2 diabetes mellitus and elevated LDL cholesterol. The study aims to determine whether adding bempedoic acid to standard dual therapy provides superior lipid control without compromising safety. The 126 participants, aged 35 - 60 years will be randomly assigned to one of three treatment groups for 12 weeks, and their lipid profiles, glycemic control, and adverse effects will be monitored.The total duration of study will be 6 months, with a 3 months individual treatment period.

Eligibility

Inclusion Criteria:

* Males and females
* Age 35-60 years
* HbA1c ≥ 7.0 (≥ 48 mmol/mol)
* On stable anti-diabetic therapy for at least 3 months
* LDL-C \> 100 mg/dL on at least two occasions
* Diagnosed with hypercholesterolemia
* Establish high cardiovascular risk (e.g, previous MI, stroke or atherosclerosis) or
* ≥2 cardiovascular risk factors (hypertension, smoking, obesity, family history)
* BMI \>23 - \<32(WHO Asian Criteria)
* No prior statin side effects

Exclusion Criteria:

* HbA1c \>10 % (86 mmol/mol)
* BMI \> 32
* Type 1 Diabetes, gestational diabetes
* Pregnancy or lactation
* Acute liver disease or ALT/AST levels \> 3× the upper limit of normal
* Renal failure (GFR \< 30 mL/min)
* Uncontrolled hypothyroidism or nephrotic syndrome
* Recent cancer diagnosis (last 6 months)
* Current use of other lipid-lowering agents (e.g., fibrates or PCSK9 inhibitors)
* Known allergy to any component
* Statin intolerance with severe adverse effects (e.g., rhabdomyolysis)

Conditions3

Interventions3

Browse More Trials