Metformin in Older Adults With Type 2 Diabetes (AMEMET)

Diabetes Mellitus, Type 2 Clinical Trial

— AMEMET  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04295031
• Other study ID #: AMEMET Study
• Status: Recruiting
• Start date: October 9, 2019
• Est. completion date: March 15, 2021

Study information

• Verified date: March 2020
• Source: Associazione Medici Endocrinologi
• Contact: Barbara Martello
• Phone: +39 0432 204050
• Email: segreteria[@]associazionemediciendocrinologi.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: March 15, 2021
• Est. primary completion date: December 31, 2020
• Gender: All
• Age group: 65 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Locations

Country	Name	City	State
Italy	AME - Associazione Medici Endocrinologi	Udine

Sponsors (1)

Lead Sponsor	Collaborator
Associazione Medici Endocrinologi

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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 Associatio — View 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. CO — View 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 — View Citation

Schlender L, Martinez YV, Adeniji C, Reeves D, Faller B, Sommerauer C, Al Qur'an T, Woodham A, Kunnamo I, Sönnichsen A, Renom-Guiteras A. Efficacy and safety of metformin in the management of type 2 diabetes mellitus in older adults: a systematic review f — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	metformin daily dose in diabetic outpatients type 2	relationship between metformin dose and filtration rate	six months
Secondary	renal filtration rate	relationship between metformin rate and concomitant medication	six months