A Prospective, Observational Study on the Use of Glucophage XR Therapy in the Management of Patients With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,592
- 试验地点
- 1
- 主要终点
- Proportion of subjects who discontinue Glucophage XR treatment prematurely (< 12 weeks) due to side effects
研究概览
简要总结
This was an observational, prospective, multicentric study conducted in a cohort of subjects with type 2 diabetes and prescribed with Glucophage XR therapy from hospitals or clinics in Hong Kong, Indonesia, Korea, Malaysia, Philippines and Singapore. Glucophage XR is being used in the Asia Pacific region for the treatment of subjects with type 2 diabetes. This study was designed to provide information on the day to-day experience of using Glucophage XR in the management of subjects with type 2 diabetes and its use in routine clinical practice in Asia Pacific region.
详细描述
Glucophage (metformin) is the standard first line therapy for subjects with type 2 diabetes mellitus (DM). The consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes has recommended metformin therapy in concurrent with lifestyle intervention at diagnosis. It has been well accepted that subjects' compliance with therapy tends to decrease as the dosage frequency increases and hence the regimens should be simplified as far as possible to support good compliance with therapy. The use of an extended release formulation of metformin (Glucophage XR) supports the simplification of treatment of subjects with type 2 diabetes by allowing a once daily administration of metformin.
OBJECTIVES
Primary objective:
- To assess the tolerability of Glucophage XR therapy when used in routine clinical practice in subjects with type 2 diabetes
Secondary objective:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects diagnosed with type 2 diabetes
- •Subjects who have been given Glucophage XR for the treatment of the type 2 diabetes
排除标准
- •Subjects treated with Glucophage XR before the study initiation
- •Contraindicated use of Glucophage XR based on local label
- •Subjects who plan to continue on another oral anti diabetic therapy during the course of the study
结局指标
主要结局
Proportion of subjects who discontinue Glucophage XR treatment prematurely (< 12 weeks) due to side effects
时间窗: Baseline to post-treatment visit (after at least 12 weeks of treatment from the baseline visit)
次要结局
- Reasons for discontinuation(At the time of discontinuation before completing the 12 weeks observation of period)
- Change in glycosylated haemoglobin (HbA1c) levels from baseline after 12 weeks(Baseline to post-treatment visit (after at least 12 weeks of treatment from the baseline visit))
- Proportion of subjects experiencing at least one gastrointestinal side effect(Baseline to post-treatment visit (after at least 12 weeks of treatment from the baseline visit) or discontinuation of treatment, whichever is earlier)
- Proportion of subjects remaining on Glucophage XR therapy for at least 12 weeks(Baseline to post-treatment visit (after at least 12 weeks of treatment from the baseline visit))
- Incidence of side effects(Baseline to post-treatment visit (after at least 12 weeks of treatment from the baseline visit) or discontinuation of treatment, whichever is earlier)