Metformin in Older Adults With Type 2 Diabetes (AMEMET)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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AMEMET Study - Observational Multicentric Clinical Study: Metformin in Patients Over 65 Years With Type 2 Diabetes (DM2)

Conditions
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Diabetes Mellitus, Type 2

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| DM2 without renal disease<br>patients with type 2 diabetes with normal renal function | |
| DM2 with renal impairment<br>patients with type 2 diabetes with impaired renal function | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| metformin daily dose in diabetic outpatients type 2 | relationship between metformin dose and filtration rate | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| renal filtration rate | relationship between metformin rate and concomitant medication | six months |