NCT06846411招募中4 期
Empagliflozin Versus Metformin for Glucose Variability and Metabolic Outcomes in Drug-Naïve Type 2 Diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- mean amplitude of glucose excursion (MAGE)
研究概览
简要总结
This multicenter, open-label, prospective study randomized 46 drug-naïve adults with T2D (HbA1c 6.5%-10.0%) to receive empagliflozin (10 mg/day) or metformin (1,000 mg/day) for 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants were eligible if they had T2D with an HbA1c between 6.5% and 10.0%, were between 20 and 75 years of age, and had not received any anti-diabetic medications for at least eight weeks prior to screening.
排除标准
- •individuals with a body mass index (BMI) <18.5 kg/m² or ≥40 kg/m², clinically significant hepatic impairment (e.g., hepatic cirrhosis, portal hypertension, chronic active hepatitis), or a history of acute cardiovascular events (e.g., coronary artery disease, cerebrovascular disease, peripheral arterial disease) within two months prior to enrollment. Participants with CKD (eGFR <60 mL/min/1.73 m²) or end-stage renal disease (eGFR <15 mL/min/1.73 m² or on dialysis) were also excluded.
- •Additional exclusion criteria included uncontrolled hypertension (BP ≥160/100 mmHg), New York Heart Association (NYHA) class III or IV heart failure, chronic oral corticosteroid use (>30 consecutive days), a history of cancer (except basal cell carcinoma) within the past five years, or significant dyslipidemia (triglycerides >1,000 mg/dL or LDL cholesterol >250 mg/dL).
研究组 & 干预措施
Standard
Active Comparator
Metformin therapy
干预措施: Metformin (Drug)
Experimental
Experimental
Empagliflozin therapy
干预措施: Empagliflozin 10 mg (Drug)
结局指标
主要结局
mean amplitude of glucose excursion (MAGE)
时间窗: 24 weeks
MAGE is a key glucose variability index that assesses the amplitude of clinically relevant glucose fluctuations and is calculated as the mean of the differences between consecutive glucose nadirs and peaks that exceed one standard deviation (SD) above or below the mean glucose level
次要结局
- SD of glucose(24 weeks)
- Time in range (TIR)(24 weeks)
- Mean Blood Glucose (MBG)(24 weeks)
- Glucose Management Indicator (GMI)(24 weeks)
- Coefficient of Variation (CV)(24 weeks)
研究者
Soo Lim
Professor
Seoul National University Bundang Hospital
研究点 (1)
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