Evaluate adherence to treatment with Glucophage sachets versus tablets in diabetes type 2 patients, previously treated with metformin tablets

MERCK, S.L.0 个研究点开始时间: 2011年10月13日最近更新: 2012年10月22日

试验速览

暂无简介。

•- Type 2 Diabetes diagnosed. Baseline Glycaemia > 7,0 mmol/L (126 mg/dL) or overload Glycemia > 11,0 mmol/L (198 mg/dL)
•- On treatment with metformin tablets
•- To fulfill at any time at least one of the following criteria for cardio-vascular risk:
•BP sistolic > 180 mmHg and/or >110 mmHg diastolic.
•BP sistolic > 160 mmHg and <70 mmHg diastolic.
•> 3 CV risk factors
•Stablished CV disease or nephropathy
•- Stablished dose of Metformin > 1.700 mg/day
•- Age > 18 years old
•- Given informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 140
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- not able to take medication orally
•- According to SmPC:
•Known hypersensitivity to metformin or any of its excipients
•Diabetic ketoacidosis or diabetic precoma in the previous week
•Renal impairment or dysfunction (Creatinine clearance < 60 mL/min)
•Acute disease which may produce renal dysfunction, tissue hypoxia as dehydration, severe infection, shock, administration of iodinated contrast.
•Acute or chronic disease which may produce tissue hypoxia as cardiovascular or respiratory collapse, recent myocardial infarction, shock.
•Liver impairment, alcohol poisoning o alcoholism
•- Participating in other clinical trial in the 30 days prior to randomisation.
•- Any other illnes or medical or psiquiatric condition, severe and uncontrolled that could interfere in the patient's participation or in the assesment of the study results.

发起方

MERCK, S.L.