International, prospective, non-interventional observational study on effectiveness, safety and tolerability of Glucobay® in routine treatment of untreated or pretreated diabetes mellitus type 2/ Impaired Glucose Tolerance
试验速览
- 阶段
- 4 期
- 入组人数
- 16,000
- 试验地点
- 80
- 主要终点
- Data collection on patients weight and waist circumference, fasting blood glucose, postprandial blood glucose (2h), HbA1C; exploratory analysis according to patient groups (concomitant cardiovascular disease groups, BMI)
研究概览
简要总结
This study is international, prospective, non-interventional observational study, data are obtained on effectiveness, safety and tolerability of Glucobay® in routine treatment. The general study objectives are to investigate the influence of Glucobay® on fasting blood glucose, postprandial blood glucose (2h), HbA1C as well as the patients weight. Glucobay® (acarbose) is taken 1-3 times daily.A biometric evaluation - primarily descriptive and exploratory - will be carried out according to a statistical analysisplan at the end of the study and summarized in a final report. All patients receiving at least one tablet will be included in the safety analysis. The results of this NIS study will be compared to the results of clinical trials.The study is planned to be carried out in 2000 patients from 80 trial sites in India.FPFV for India - 21 JUNE 2010.
研究设计
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
入选标准
- •All patients with untreated or pretreated diabetes mellitus type 2/ IGT can be included into the study.
- •No Glucobay® intake within the last 3 months before documentation of initial visit.
排除标准
- •contraindication stated in the local Glucobay® product information; warnings and precautionsmust be considered.
结局指标
主要结局
Data collection on patients weight and waist circumference, fasting blood glucose, postprandial blood glucose (2h), HbA1C; exploratory analysis according to patient groups (concomitant cardiovascular disease groups, BMI)
时间窗: Time Frame: During observation period of three months ] [ Designated as safety issue: No ]
次要结局
未报告次要终点