Diabetes Mellitus, Type 2AMEMETNCT04295031
Metformin in Older Adults With Type 2 Diabetes (AMEMET)
An observational study of Diabetes Mellitus, Type 2, run by Associazione Medici Endocrinologi at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- How many people
- 1,500 participants
- Where
- 1 siteItaly
- Study dates
- 9 Oct 2019to 15 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- Older adult
Study population: All diabetic patients respecting eligibility criteria
Who may be able to join
- adult outpatients (≥65 years);
- T2 diabetes mellitus;
- Taking metformin for at least six months;
- assuming three daily meals;
- capable of informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Giorgio Borretta, MD contact
Italy1 site, 1 recruiting
- Recruiting
AME - Associazione Medici Endocrinologi
Udine, 33100
Barbara Martello, +39 0432 204050, segreteria@associazionemediciendocrinologi.it
Giorgio Borretta, MD, borretta.giorgio@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
metformin daily dose in diabetic outpatients type 2
relationship between metformin dose and filtration rate
Measured: six months
Secondary outcomes (1)
renal filtration rate
relationship between metformin rate and concomitant medication
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start9 Oct 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion15 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Associazione Medici Endocrinologi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giorgio Borretta, MD, Principal investigator, Associazione Medici Endocrinologi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04295031
- Sponsor's protocol ID
- AMEMET Study
- Acronym
- AMEMET
- Status last verified
- Mar 2020
- First submitted
- 21 Feb 2020
- Last updated
- 4 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30903688Davies 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.
PubMed 30288571Garber 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.
PubMed 30742570Schlender 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.
PubMed 29047344
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AMEMET Study - Observational Multicentric Clinical Study: Metformin in Patients Over 65 Years With Type 2 Diabetes (DM2)
- ClinicalTrials.gov ID
- NCT04295031
- Acronym / sponsor ID
- AMEMET / AMEMET Study
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Associazione Medici EndocrinologiUniversity, hospital or other
- Study start
- 9 Oct 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 15 Mar 2021 (estimated)
- First posted
- 4 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Age groups
- Older adult
- Study population
- All diabetic patients respecting eligibility criteria
Key inclusion criteria (5 listed)
- adult outpatients (≥65 years);
- T2 diabetes mellitus;
- Taking metformin for at least six months;
- assuming three daily meals;
- capable of informed consent.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
metformin daily dose in diabetic outpatients type 2
Time frame: six months
relationship between metformin dose and filtration rate
1 secondary outcome
renal filtration rate
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- Results publication: PubMed 30903688LeRoith 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.
- Results publication: PubMed 30288571Davies 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.
- Results publication: PubMed 30742570Garber 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.
- Results publication: PubMed 29047344Schlender 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giorgio Borretta, MD contact
Giorgio Borretta, MD principal investigator
Associazione Medici Endocrinologi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by Associazione Medici Endocrinologi at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Barbara Martello (+39 0432 204050, segreteria@associazionemediciendocrinologi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
metformin daily dose in diabetic outpatients type 2 (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04295031, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2020.