Metformin in Older Adults With Type 2 Diabetes (AMEMET) (AMEMET)

March 3, 2020 updated by: Associazione Medici Endocrinologi

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

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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 90 years (Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All diabetic patients respecting eligibility criteria

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
DM2 without renal disease
patients with type 2 diabetes with normal renal function
DM2 with renal impairment
patients with type 2 diabetes with impaired renal function

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Associazione Medici Endocrinologi

Investigators

  • Principal Investigator: Giorgio Borretta, MD, Associazione Medici Endocrinologi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2019

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

March 15, 2021

Study Registration Dates

First Submitted

February 21, 2020

First Submitted That Met QC Criteria

March 3, 2020

First Posted (Actual)

March 4, 2020

Study Record Updates

Last Update Posted (Actual)

March 4, 2020

Last Update Submitted That Met QC Criteria

March 3, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMEMET Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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