Effectiveness Of Bempedoic Acid -Ezetimibe Fixed Dose Combination On Insulin Sensitivity In Diabetic Dyslipidemic Patients - A Prospective, Open-label, Randomized Controlled Trial.
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To assess the insulin sensitivity using HOMA IR index score and improvement of beta cell function C peptide.
研究概览
简要总结
This is a randomized, open label, prospective study which involves patients above 18 years of age who are diagnosed with Type 2 Diabetes Mellitus and dyslipidemia.
Participants receiving baseline statin therapy should have fasting LDL-C level of 100mg/dL or higher at first screening visit.
Patients are randomized into 3 groups based on Random allocation software version 2.0
Initial Evaluations: VISIT-0 (Day-1)
Fasting Blood Glucose
Fasting Insulin
Fasting Low Density Lipoprotein
Fasting Total Cholesterol
HbA1c
Postprandial Blood Glucose
Fasting C- Peptide
Fasting Triglycerides
HOMA-IR index score online calculator
KIER Scoring Scale
Group 1 (Test group 1): Involves 30 patients administered with Bempedoic acid(180mg) + Ezetimibe(10mg) as a fixed dose combination over baseline statin therapy for 90 days (Once daily) at bedtime.
Group 2 (Test group 2): Involves 30 patients administered with Ezetimibe(10mg) as a monotherapy over baseline statin therapy for 90 days (Once daily) at bedtime.
Group 3 (Control group): Involves 30 patients continuing existing statin therapy.
Patients are contacted through telephone regarding medication adherence on visit 1 (Day-30) and visit 2 (Day-60).
Patients are requested for In-person visit 3 (Day 90) for the follow up with above mentioned parameters.
The results are statistically compared and reported after 90 days of treatment.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Men and women above 18 years of age are include.
- •Patients diagnosed with Type 2 Diabetes Mellitus and dyslipidemia.
- •Participants receiving baseline statin therapy should have fasting LDL-C level of 100mg/dL or higher at first screening visit.
- •Patients receiving antihyperglycemic medication before randomization and HbA1c between 6.5% to 10% at randomization.
排除标准
- •Patients with recent history of clinically significant cardiovascular disease, including uncontrolled hypertension, planned revascularization procedure, NYHA class IV heart failure.
- •Myocardial infarction, severe or unstable angina, coronary angioplasty, coronary artery bypass graft surgery, stroke, transient ischaemic attack within 3 months of screening are excluded.
结局指标
主要结局
To assess the insulin sensitivity using HOMA IR index score and improvement of beta cell function C peptide.
时间窗: After 90 days
次要结局
- To compare the reduction in HbA1c levels and reducing LDL-C and total cholesterol levels in diabetic dyslipidemic patients.(After 90 days)
研究者
Dr J S Kumar
SRM Institute