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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age35-60
SponsorBahria University

About this trial

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 criteria

Qualifiers

Males and females

Age 35-60 years

HbA1c ≥ 7.0 (≥ 48 mmol/mol)

On stable anti-diabetic therapy for at least 3 months

Disqualifiers

HbA1c >10 % (86 mmol/mol)

BMI > 32

Type 1 Diabetes, gestational diabetes

Pregnancy or lactation

Trial design

Treatments tested in this trial

  • Rosuvastatin + Ezetimibe
  • Bempedoic Acid + Ezetimibe
  • Rosuvastatin + Ezetimibe + Bempedoic Acid

Treatment groups

126 Participants
are divided into 3 treatment groups

Sponsors and collaborators