NCT06399835招募中4 期
Comparing Enavogliflozin and Pioglitazone as Add-ons to Metformin With/Without Dipeptidyl Peptidase-4 Inhibitors in 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
- 120
- 试验地点
- 2
- 主要终点
- Changes of HbA1c from the baseline
研究概览
简要总结
The current study aimed to thoroughly compare a thiazolidinedione and an sodium-glucose cotransporter-2 (SGLT2) inhibitor regarding various clinical issues including atherosclerosis. Enavogliflozin is compared to Pioglitazone in the glucose-lowering effects of adding to the treatment of patients with type 2 diabetes whose HbA1c levels are not controlled by Metformin with or without DPP-4 inhibitors. Additionally, the study will compare changes in other metabolic or cardiovascular risk factors, such as triglycerides, high density lipoprotein cholesterol (HDLc), uric acid, blood pressure, and inflammatory markers, between the two drugs.
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
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes patients with a glycated hemoglobin (HbA1c) level of 7.0 - 10.5% at screening
- •Males or females aged 20-80 years
- •Individuals who have been taking Metformin (≥ 500mg) with or without a DPP-4 inhibitor (such as Sitagliptin, Vildagliptin, Saxagliptin, Linagliptin, Gemigliptin, Alogliptin, Teneligliptin, Anagliptin, Evogliptin) for at least the past 3 months
- •Body mass index ≥ 23 kg/m²
- •Estimated glomerular filtration ratio (eGFR) ≥ 60 ml/min/1.73m²
排除标准
- •Patients with Type 1 Diabetes, Gestational Diabetes, or secondary diabetes due to other causes
- •Patients with a history of acute cardiovascular disease within the last 3 months prior to the screening visit
- •Pregnant or breastfeeding patients, or patients not using contraception. Patients with chronic Hepatitis B or C (excluding healthy carriers of Hepatitis B), or liver disease (aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3 times the upper limit of normal)
- •Patients with heart failure or a history of heart failure
- •Individuals with a history of cancer within the past 5 years (excluding those adequately treated for squamous cell carcinoma or thyroid cancer)
- •Patients who have participated in another clinical study within the last 30 days
- •Alcohol addiction
- •Patients for whom the use of Enavogliflozin or Pioglitazone is contraindicated
- •Patients taking other oral hypoglycemic agents or insulin or other investigational drugs
- •Patients deemed unsuitable for the study based on the investigator's judgment
研究组 & 干预措施
Enavogliflozin
Experimental
Enavogliflozin 0.3 mg
干预措施: Enavogliflozin (Drug)
Pioglitazone
Active Comparator
Pioglitazone 15 mg
干预措施: Pioglitazone (Drug)
结局指标
主要结局
Changes of HbA1c from the baseline
时间窗: 24 weeks
%
次要结局
- Changes of electrolytes (uric acid)(12 weeks, 24 weeks)
- Changes in parathyroid hormone(12 weeks, 24 weeks)
- Changes in 25-hydroxyl vitamin D3(12 weeks, 24 weeks)
- Changes of urine electrolytes (Na, K, Cl, Ca, P, glucose)(12 weeks, 24 weeks)
- Changes of lipids (total cholesterol, HDLc, low density lipoprotein cholesterol [LDLc], triglycerides)(12 weeks, 24 weeks)
- Patients achieving HbA1c levels below 7%(24 weeks)
- Changes of body fat (whole body fat, abdominal fat)(24 weeks)
- Changes of body weight(12 weeks, 24 weeks)
- Changes of glucose levels (fasting, 2-hour postprandial)(12 weeks, 24 weeks)
- Changes of systolic/diastolic blood pressures(12 weeks, 24 weeks)
- Changes of albuminuria(12 weeks, 24 weeks)
- Changes of carotid intima-media thickness(24 weeks)
- Changes in ketone body(12 weeks, 24 weeks)
研究者
Soo Lim
Professor
Seoul National University Bundang Hospital
研究点 (2)
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