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

ConditionsType 2 Diabetes MellitusHypercholesterolemia / 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Rosuvastatin + Ezetimibe

    Drug

    Group A (Dual therapy 1): Tab Rosuvastatin 20 mg + Tab Ezetimibe 10mg (FDC) orally, once daily for 90 days

  • Bempedoic Acid + Ezetimibe

    Drug

    Group B (Dual therapy 2): Tab Bempedoic Acid 180mg+ Tab Ezetimibe 10mg (FDC) orally, once daily for 90 days

  • Rosuvastatin + Ezetimibe + Bempedoic Acid

    Drug

    Group C (Triple therapy): Tab Rosuvastatin 20 mg+ Tab Ezetimibe 10mg+ Tab Bempedoic Acid 180mg orally, once daily for 90 days

Treatment groups

126 Participants
are divided into 3 treatment groups
Group A: Rosuvastatin + EzetimibeActive comparator 1 intervention
Group B: Bempedoic Acid + EzetimibeActive comparator 1 intervention
Group C: Rosuvastatin + Ezetimibe + Bempedoic AcidActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Primary outcome: Percent Change in LDL-C From Baseline to 12 Weeks and Proportion of Participants Achieving LDL-C <70 mg/dL

The study will measure the percent change in LDL-C from baseline to 12 weeks and the proportion of participants achieving LDL-C \<70 mg/dL as per international guidelines.

Time frame
12 weeks

Secondary outcomes

1

Secondary outcome : Change in Total Cholesterol Level From Baseline to 12 Weeks (mg/dL)

The study will measure the change in total cholesterol (mg/dL) from baseline to 12 weeks to evaluate the efficacy of dual and triple lipid-lowering therapies.

Time frame
12 weeks
2

Secondary Outcome : Change in Triglyceride Level From Baseline to 12 Weeks (mg/dL)

The study will measure the change in Triglyceride Level from baseline to 12 weeks to evaluate the efficacy of dual and triple lipid-lowering therapies.

Time frame
12 weeks
3

Secondary Outcome : Change in HDL-C Level From Baseline to 12 Weeks (mg/dL)

The study will measure the change in HDL-C Level from baseline to 12 weeks to evaluate the efficacy of dual and triple lipid-lowering therapies.

Time frame
12 weeks
4

Secondary Outcome : Change in VLDL Level From Baseline to 12 Weeks (mg/dL)

The study will measure the change in VLDL Level from baseline to 12 weeks to evaluate the efficacy of dual and triple lipid-lowering therapies.

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bahria University

Lead sponsor

Source ClinicalTrials.gov
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