NCT04295031

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 9, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 4, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2021

Completed
Last Updated

March 4, 2020

Status Verified

March 1, 2020

Enrollment Period

1.2 years

First QC Date

February 21, 2020

Last Update Submit

March 3, 2020

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • metformin daily dose in diabetic outpatients type 2

    relationship between metformin dose and filtration rate

    six months

Secondary Outcomes (1)

  • renal filtration rate

    six months

Study Arms (2)

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

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All diabetic patients respecting eligibility criteria

You may qualify if:

  • adult outpatients (≥65 years);
  • T2 diabetes mellitus;
  • Taking metformin for at least six months;
  • assuming three daily meals;
  • capable of informed consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AME - Associazione Medici Endocrinologi

Udine, 33100, Italy

RECRUITING

Related Publications (4)

  • 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.

    PMID: 30903688RESULT

  • 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.

    PMID: 30288571RESULT

  • 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.

    PMID: 30742570RESULT

  • 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.

    PMID: 29047344RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Giorgio Borretta, MD

    Associazione Medici Endocrinologi

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbara Martello

CONTACT

+39 0432 204050segreteria@associazionemediciendocrinologi.it

Giorgio Borretta, MD

CONTACT

borretta.giorgio@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2020

First Posted

March 4, 2020

Study Start

October 9, 2019

Primary Completion

December 31, 2020

Study Completion

March 15, 2021

Last Updated

March 4, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)