Clinical trial NCT04295031: Metformin in Older Adults With Type 2 Diabetes (AMEMET)
Official title: AMEMET Study - Observational Multicentric Clinical Study: Metformin in Patients Over 65 Years With Type 2 Diabetes (DM2)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Associazione Medici Endocrinologi
Sponsor class: OTHER
First posted: 2020-03-04
Enrollment: 1500
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All diabetic patients respecting eligibility criteria

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: metformin daily dose in diabetic outpatients type 2
timeFrame: six months
Secondary outcomes:
measure: renal filtration rate
timeFrame: six months
Other outcomes:
Locations:
city: Udine
country: Italy
facility: AME - Associazione Medici Endocrinologi
Study officials:
affiliation: Associazione Medici Endocrinologi
name: Giorgio Borretta, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: LeRoith D, Biessels GJ, Braithwaite SS, Casanueva FF, Draznin B, Halter JB, Hirsch IB, McDonnell ME, Molitch ME, Murad MH, Sinclair AJ. Treatment of Diabetes in Older Adults: An Endocrine Society* Clinical Practice Guideline. J Clin Endocrinol Metab. 2019 May 1;104(5):1520-1574. doi: 10.1210/jc.2019-00198.
citation: Davies MJ, D'Alessio DA, Fradkin J, Kernan WN, Mathieu C, Mingrone G, Rossing P, Tsapas A, Wexler DJ, Buse JB. Management of hyperglycaemia in type 2 diabetes, 2018. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetologia. 2018 Dec;61(12):2461-2498. doi: 10.1007/s00125-018-4729-5.
citation: Garber AJ, Abrahamson MJ, Barzilay JI, Blonde L, Bloomgarden ZT, Bush MA, Dagogo-Jack S, DeFronzo RA, Einhorn D, Fonseca VA, Garber JR, Garvey WT, Grunberger G, Handelsman Y, Hirsch IB, Jellinger PS, McGill JB, Mechanick JI, Rosenblit PD, Umpierrez GE. CONSENSUS STATEMENT BY THE AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY ON THE COMPREHENSIVE TYPE 2 DIABETES MANAGEMENT ALGORITHM - 2019 EXECUTIVE SUMMARY. Endocr Pract. 2019 Jan;25(1):69-100. doi: 10.4158/CS-2018-0535. No abstract available.
citation: Schlender L, Martinez YV, Adeniji C, Reeves D, Faller B, Sommerauer C, Al Qur'an T, Woodham A, Kunnamo I, Sonnichsen A, Renom-Guiteras A. Efficacy and safety of metformin in the management of type 2 diabetes mellitus in older adults: a systematic review for the development of recommendations to reduce potentially inappropriate prescribing. BMC Geriatr. 2017 Oct 16;17(Suppl 1):227. doi: 10.1186/s12877-017-0574-5.