Metformin Use in Chronic Kidney Disease: The CKD-Met Study (CKD-Met)

July 25, 2016 updated by: Hospices Civils de Lyon

Metformin is the most widely prescribed oral treatment for diabetes, and the only one that showed a survival benefit.

Yet, there is no consensus on the optimal dose and withdrawal of metformin in chronic kidney disease (CKD) patients.

The aim of the study is to describe the use and side-effects of metformin in CKD patients in routine practice.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1000

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 Locations

  • France
      • Pierre-Bénite, France, 69310
        • Recruiting
        • Claude Bernard University, Lyon, France, Lyon Sud university hospital
        • Contact:

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients with type 2 diabetes seen by a nephrologist at the University hospital of Lyon Sud, between March 2014 and March 2020

Description

Inclusion Criteria:

  • 18 years old or more
  • Type 2 diabetes
  • Seen by a nephrologist (consultation or hospitalization) between March 2014 and March 2020 in the Department of Nephrology, Lyon Sud university hospital, France

Exclusion Criteria:

  • On-going treatment by dialysis
  • Kidney transplantation
  • Type 1 diabetes
  • Missing data (metformin treatment)

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
Intervention / Treatment
6 groups, for each CKD stage (1, 2, 3a, 3b, 4, 5)
All patients with type 2 diabetes seen for the first time by a nephrologist.
Other: modalities of metformin prescription
Metformin prescription or not, in each CKD stage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients receiving metformin
Time Frame: every January 1st up to 2020
metformin use during chronic kidney disease. Percentage of patients receiving metformin will be recorded.
every January 1st up to 2020

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose of metformin
Time Frame: every January 1st up to 2020
metformin use during chronic kidney disease. Dose of metformin will be recorded.
every January 1st up to 2020
Occurence of reasons for non-prescription of metformin
Time Frame: every January 1st up to 2020
metformin use during chronic kidney disease. Occurence of reasons for non-prescription of metformin will be recorded.
every January 1st up to 2020
CKD stages
Time Frame: every January 1st up to 2020
CKD stages will be recorded.
every January 1st up to 2020
Doses of oral antidiabetes medications
Time Frame: every January 1st up to 2020
Oral antidiabetic medications use during chronic kidney disease. Doses of oral antidiabetes medications (sulfonylureas, alpha-glucosidase inhibitors, Dipeptidyl peptidase-4 (DPP4) inhibitors, incretin mimetics, SGLT2 inhibitors) will be recorded.
every January 1st up to 2020
starting time of insulin
Time Frame: every January 1st up to 2020
need for insulin
every January 1st up to 2020
occurrence of lactic acidosis
Time Frame: every January 1st up to 2020
data file analysis and record of lactic acidosis episodes
every January 1st up to 2020

Collaborators and Investigators

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

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Denis FOUQUE, MD PhD, Claude Bernard University, Lyon, France, Lyon Sud university hospital

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

March 1, 2014

Primary Completion (Anticipated)

March 1, 2018

Study Completion (Anticipated)

March 1, 2020

Study Registration Dates

First Submitted

July 20, 2016

First Submitted That Met QC Criteria

July 25, 2016

First Posted (Estimate)

July 26, 2016

Study Record Updates

Last Update Posted (Estimate)

July 26, 2016

Last Update Submitted That Met QC Criteria

July 25, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL16_0408

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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