Diabetes Mellitus, Type 2 Clinical Trial
Official title:
AMEMET Study - Observational Multicentric Clinical Study: Metformin in Patients Over 65 Years With Type 2 Diabetes (DM2)
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.
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.
Each participating center recruited about 50 diabetic outpatients. Inclusion criteria were as
follows: adult outpatients ≥ 65 years with T2 diabetes mellitus, using metformin for at least
six months, usually assuming three daily meals, and capable of informed consent.
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