Acarbose in Cardiovascular Risk Management. Assessment of Clinical Efficacy and Safety of Acarbose and Its Effect on Selected Cardiovascular Risk Factors in Type 2 Diabetes Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 3,310
- 主要终点
- Safety, tolerability of acarbose and its effect on body weight, waist circumference and blood pressure
研究概览
简要总结
The use of acarbose in impaired glucose tolerance (IGT) and type 2 diabetic subjects has been associated with a significant reduction of cardiovascular events. Additionally, acarbose has been shown to have a beneficial influence on some of the other cardiovascular risk factors (metabolic syndrome components). Thus, prevention of postprandial hyperglycemia by acarbose may be a promising therapeutic strategy for reducing the increased risk for cardiovascular disease. Further studies are needed to confirm the influence of acarbose on cardiovascular risk factors in the real life setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes Mellitus
- •Age >/= 18 years
- •Naive to acarbose (minimum 3 months before inclusion)
排除标准
- •Hypersensitivity to acarbose or any of the excipients
- •Age <18 years
- •Pregnancy and in nursing
- •Inflammatory bowel disease, colonic ulceration, partial intestinal obstruction or in patients predisposed to intestinal obstruction
- •Chronic intestinal diseases associated with marked disorders of digestion or absorption
- •States which may deteriorate as a result of increased gas formation in the intestine, (e.g. Roemheld's syndrome [an angina pectoris-like syndrome or aggravation of an angina pectoris due to the postprandial filling of the stomach] and larger hernias)
- •Hepatic and severe renal impairment (creatinine clearance <25 mL/min/ 1,73m2)
研究组 & 干预措施
Group 1
干预措施: Acarbose (Glucobay, BAYG5421) (Drug)
结局指标
主要结局
Safety, tolerability of acarbose and its effect on body weight, waist circumference and blood pressure
时间窗: approximately 6 months after acarbose treatment initiation
次要结局
- Effect of acarbose on HbA1c, fasting and postprandial glycemia and on lipid profile(approximately 6 months after acarbose treatment initiation)