Metformin in Older Adults With Type 2 Diabetes (AMEMET)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-09

Study Completion Date

2021-03-15

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.

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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.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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DM2 without renal disease

patients with type 2 diabetes with normal renal function

No interventions assigned to this group

DM2 with renal impairment

patients with type 2 diabetes with impaired renal function

No interventions assigned to this group

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.

Minimum Eligible Age

65 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No