Metformin in Older Adults With Type 2 Diabetes (AMEMET)

Associazione Medici Endocrinologi

Status: Unknown

Conditions: Diabetes Mellitus, Type 2

Study type: Observational

Funder types: Other

Identifiers

NCT04295031

AMEMET Study

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,500 estimated patients

Sex: All

Ages: 65 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult outpatients (≥65 years);
• T2 diabetes mellitus;
• Taking metformin for at least six months;
• assuming three daily meals;
• capable of informed consent.

Exclusion criteria

• 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.

Trial design

1,500 participants in 2 patient groups

DM2 without renal disease

Description:

patients with type 2 diabetes with normal renal function

DM2 with renal impairment

Description:

patients with type 2 diabetes with impaired renal function