NCT01510522撤回4 期
Evaluate Adherence to Treatment With Glucophage Sachets Versus Tablets in Diabetes Type 2 Patients, Previously Treated With Metformin Tablets
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Change from Baseline of Patient self-reported subjective compliance as assessed by Haynes-Sackett test at Month 6
研究概览
简要总结
This is an open-label, multicenter, two-arm, parallel, randomized phase 4 study to compare the compliance in diabetes type 2 patients treated with Glucophage sachets versus patients treated with Glucophage tablets.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes mellitus type 2 diagnosed (Baseline Glycemia > 7,0 mmol/L (126 mg/dL) or overload Glycemia > 11,0 mmol/L (198 mg/dL)
- •On treatment with metformin tablets
- •Patients with at least 2 treated co-morbidities
- •Established dose of Metformin > 1.700 mg/day
- •Age > 18 years old
- •Given informed consent
排除标准
- •Patients not able to take medication orally
- •According to Summary of Product Characteristics (SmPC)
- •Participating in another clinical trial 30 days prior to randomization
- •Any other illness or medical or psychiatric condition, severe and uncontrolled that could interfere in the patient's participation or in the assessment of the study results
研究组 & 干预措施
Glucophage sachets
Experimental
Patients receive Glucophage sachets, the powder formulation for oral solution in sachets.
干预措施: Glucophage (Drug)
Glucophage tablets
Active Comparator
Patients received Glucophage tablets.
干预措施: Glucophage (Drug)
结局指标
主要结局
Change from Baseline of Patient self-reported subjective compliance as assessed by Haynes-Sackett test at Month 6
时间窗: Month 6
次要结局
- Objective compliance to treatment(Month 3 and month 6)
- Rate of reported adverse events(Month 3 and month 6)
- Evaluation of treatment satisfaction and preferences with the Diabetes Treatment Satisfaction Questionnaire (DTSQ)(Baseline, month 3 and month 6)
研究者
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