AMEMET Study - Observational Multicentric Clinical Study: Metformin in Patients Over 65 Years With Type 2 Diabetes (DM2)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- metformin daily dose in diabetic outpatients type 2
研究概览
简要总结
Multicentric, observational, cross-sectional study in Italy. The aims are to evaluate the daily metformin prescribed dose and the impact of renal function and concomitant medication in diabetic patients over 65 years.
详细描述
The study was commissioned by the Italian Association of Clinical Endocrinologists (Association of Medical Endocrinologists - AME) and approved by the Ethical Committee of Cuneo Hospital. The research was open to all specialists taking care of patients with diabetes in Italy.
The primary endpoint was the evaluation of metformin dosage. Secondary endpoints were the relationship between the metformin dosage and the renal filtration rate and the relationship between the metformin dosage and the concomitant medication.
An ad hoc form was developed and used to record all medical findings. The form was emailed to all participating centers who then emailed or faxed it back to the investigator's data manager. Data were checked for accuracy.
The following data were required: age, gender, body weight and height, diabetes duration, type of metformin (classical/slow), daily dosage of metformin, reported side effects,concomitant medications.
Serum creatinine and HbA1c levels obtained within the previous two months were also required.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 65 Years 至 90 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult outpatients (≥65 years);
- •T2 diabetes mellitus;
- •Taking metformin for at least six months;
- •assuming three daily meals;
- •capable of informed consent.
排除标准
- •severe liver or renal failure (eGFR <30 mL/min/1.73 m2);
- •hospitalization for any cause in the last six month;
- •glucocorticoid treatment in the last six month;
- •oncologic treatment in the last six month;
- •Ramadan in the last six months.
结局指标
主要结局
metformin daily dose in diabetic outpatients type 2
时间窗: six months
relationship between metformin dose and filtration rate
次要结局
- renal filtration rate(six months)